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cardiac surgery

compare the

 

 

surgery requiring

presence of

 

n, mortality,

groups (43

 

 

similar in the 2 groups. This

in the setting of

efficacy of

 

 

sternotomy were

active

 

characteristic

cases in the

 

 

trial suggests that

a high

vancomycin

 

 

considered

infection, the

 

s of

vancomycin

 

 

vancomycin and cefazolin

prevalence of

prophylaxis

 

 

eligible for the

use of

 

microorganis

group, 9.5%, vs.

 

 

have similar efficacy in

methicillin-

with that of

 

 

trial.

antibiotics

 

ms isolated

39 cases in the

 

 

preventing SSI in cardiac

resistant

cefazolin in

 

 

 

within 2 wk

 

from the

cefazolin group,

 

 

surgery.

staphylococcal

preventing

 

 

 

before the

 

infection site

9.0%, p=0.8).

 

 

 

infections. 2002

SSI in a

 

 

 

operation,

 

 

Superficial and

 

 

 

(245)

tertiary

 

 

 

and a

 

 

deep incisional

 

 

 

 

medical

 

 

 

previous

 

 

SSI rates were

 

 

 

 

center with a

 

 

 

cardiac

 

 

also similar in

 

 

 

 

high

 

 

 

operation

 

 

the 2 groups.

 

 

 

 

prevalence of

 

 

 

requiring

 

 

SSI caused by

 

 

 

 

methicillin-

 

 

 

sternotomy

 

 

methicillin-

 

 

 

 

resistant

 

 

 

within 1 y of

 

 

susceptible

 

 

 

 

staphylococca

 

 

 

enrollment in

 

 

staphylococci

 

 

 

 

l infections.

 

 

 

this trial.

 

 

were

 

 

 

 

 

 

 

 

 

 

 

significantly

 

 

 

 

 

 

 

 

 

 

 

more common

 

 

 

 

 

 

 

 

 

 

 

in the

 

 

 

 

 

 

 

 

 

 

 

vancomycin

 

 

 

 

 

 

 

 

 

 

 

group (17 cases,

 

 

 

 

 

 

 

 

 

 

 

3.7%, vs. 6

 

 

 

 

 

 

 

 

 

 

 

cases, 1.3%;

 

 

 

 

 

 

 

 

 

 

 

p=0.04).

 

 

 

Comparative

To compare 3

RCT

321

Adult patients

Patients with

The

The mean

The prevalence

p=0.05

N/A

Vancomycin deserves

study of

regimens,

 

 

undergoing

renal disease

prevalence of

duration of

of surgical

(prevalenc

 

consideration for inclusion

cefazolin,

using

 

 

cardiac or major

or evidence

surgical

postoperative

wound infection

e of

 

in the prophylactic regimen

cefamandole,

intravenous

 

 

vascular

of infection at

wound

hospitalizatio

was lowest with

surgical

 

(1) for prosthetic valve

and

cefazolin,

 

 

operations who

the time of

infection

n, adverse

vancomycin (4

wound

 

replacement and prosthetic

vancomycin for

cefamandole,

 

 

did not have renal

operation and

 

effects

infections

infections

 

vascular graft implantation,

surgical

or

 

 

disease or

with a known

 

 

[3.7%] vs. 14

in

 

to reduce the risk of implant

prophylaxis in

vancomycin

 

 

evidence of

adverse

 

 

[12.3%] and 13

vancomyci

 

infection by methicillin-

cardiac and

for

 

 

infection at the

reaction to a

 

 

[11.5%] in the

n group

 

resistant coagulase-negative

vascular

prophylaxis

 

 

time of operation

beta-lactam

 

 

cefazolin and

vs.

 

staphylococci and

operations: a

against SSI.

 

 

and had not had a

antibiotic or

 

 

cefamandole

cefazolin

 

enterococci; (2) for any

double-blind

 

 

 

known adverse

vancomycin

 

 

groups,

and

 

cardiovascular operation if

randomized

 

 

 

reaction to a beta-

were

 

 

respectively;

cefamando

 

the patient has recently

trial. 1992 (246)

 

 

 

lactam antibiotic

excluded.

 

 

p=0.05); there

le)

 

received broad-spectrum

 

 

 

 

or vancomycin

 

 

 

were no

 

 

antimicrobial therapy; and

 

 

 

 

were eligible for

 

 

 

thoracic wound

 

 

(3) for all CV operations in

 

 

 

 

participation in

 

 

 

infections in

 

 

centers with a high

© American College of Cardiology Foundation and American Heart Association, Inc.

 

 

 

 

this study.

 

 

 

cardiac

 

 

prevalence of surgical

 

 

 

 

 

 

 

 

operations in

 

 

infection with methicillin-

 

 

 

 

 

 

 

 

the vancomycin

 

 

resistant staphylococci or

 

 

 

 

 

 

 

 

group (p=0.04).

 

 

enterococci.

 

 

 

 

 

 

 

 

The mean

 

 

 

 

 

 

 

 

 

 

 

duration of

 

 

 

 

 

 

 

 

 

 

 

postoperative

 

 

 

 

 

 

 

 

 

 

 

hospitalization

 

 

 

 

 

 

 

 

 

 

 

was lowest in

 

 

 

 

 

 

 

 

 

 

 

the vancomycin

 

 

 

 

 

 

 

 

 

 

 

group (10.1 d;

 

 

 

 

 

 

 

 

 

 

 

p<0.01) and

 

 

 

 

 

 

 

 

 

 

 

highest in the

 

 

 

 

 

 

 

 

 

 

 

cefazolin group

 

 

 

 

 

 

 

 

 

 

 

(12.9 d). Thus,

 

 

 

 

 

 

 

 

 

 

 

administration

 

 

 

 

 

 

 

 

 

 

 

of vancomycin

 

 

 

 

 

 

 

 

 

 

 

(approximately

 

 

 

 

 

 

 

 

 

 

 

15 mg/kg),

 

 

 

 

 

 

 

 

 

 

 

immediately

 

 

 

 

 

 

 

 

 

 

 

preoperatively,

 

 

 

 

 

 

 

 

 

 

 

provides

 

 

 

 

 

 

 

 

 

 

 

therapeutic

 

 

 

 

 

 

 

 

 

 

 

blood levels for

 

 

 

 

 

 

 

 

 

 

 

surgical

 

 

 

 

 

 

 

 

 

 

 

prophylaxis

 

 

 

 

 

 

 

 

 

 

 

throughout

 

 

 

 

 

 

 

 

 

 

 

most cardiac

 

 

 

 

 

 

 

 

 

 

 

and vascular

 

 

 

 

 

 

 

 

 

 

 

operations,

 

 

 

 

 

 

 

 

 

 

 

resulting in

 

 

 

 

 

 

 

 

 

 

 

protection

 

 

 

 

 

 

 

 

 

 

 

against

 

 

 

 

 

 

 

 

 

 

 

postoperative

 

 

 

 

 

 

 

 

 

 

 

infection

 

 

 

 

 

 

 

 

 

 

 

superior to that

 

 

 

 

 

 

 

 

 

 

 

obtained with

 

 

 

 

 

 

 

 

 

 

 

cefazolin or

 

 

 

 

 

 

 

 

 

 

 

cefamandole.

 

 

 

Comparative

The primary

RCT

3,027

Adult (≥18 y of

Exclusion

SSI rates at

Bacteremia,

Thirty day

p=0.032

N/A

Cefazolin was more

efficacy of

objective of

 

 

age) patients

criteria

hospital

respiratory

postoperatively,

(DSWI at

 

effective prophylaxis than

teicoplanin and

the study was

 

 

undergoing

included the

discharge, 30 d

infections,

there was a

6 mo)

 

teicoplanin against

© American College of Cardiology Foundation and American Heart Association, Inc.

cefazolin for

to compare

 

 

elective CABG,

following:

postoperativel

UTI at

trend to more

 

 

postoperative wound

cardiac

the efficacy

 

 

valve operations

patients who

y, 6 mo

hospital

deep

 

 

infections after elective

operation

of single-dose

 

 

(replacement or

were

postoperativel

discharge, 30

sternotomy

 

 

cardiac operations.

prophylaxis in

teicoplanin

 

 

repair), or both

pregnant and

y

d

wound

 

 

 

3,027 patients.

with

 

 

were eligible for

those who

 

postoperativel

infections in the

 

 

 

2000 (247)

multiple-dose

 

 

the trial.

had

 

y, 6 mo

teicoplanin

 

 

 

 

cefazolin in

 

 

 

previously

 

postoperativel

group (31 vs.

 

 

 

 

the

 

 

 

undergone

 

y

18, p=0.087),

 

 

 

 

prophylaxis

 

 

 

sternotomy

 

 

which became

 

 

 

 

of SSI 1 mo

 

 

 

procedures;

 

 

significant by 6

 

 

 

 

after elective

 

 

 

patients with

 

 

m (36 vs. 19;

 

 

 

 

cardiac

 

 

 

severe

 

 

p=0.032).

 

 

 

 

operations.

 

 

 

concomitant

 

 

Infection rates

 

 

 

 

Secondary

 

 

 

diseases, such

 

 

were low with

 

 

 

 

objectives

 

 

 

as the

 

 

either treatment.

 

 

 

 

were to

 

 

 

immunocomp

 

 

 

 

 

 

 

compare both

 

 

 

romised;

 

 

 

 

 

 

 

drugs in the

 

 

 

patients who

 

 

 

 

 

 

 

prevention of

 

 

 

were

 

 

 

 

 

 

 

SSI at the

 

 

 

morbidly

 

 

 

 

 

 

 

time of

 

 

 

obese; and

 

 

 

 

 

 

 

hospital

 

 

 

individuals

 

 

 

 

 

 

 

discharge and

 

 

 

with

 

 

 

 

 

 

 

6 mo

 

 

 

osteotomies.

 

 

 

 

 

 

 

postoperativel

 

 

 

Medically

 

 

 

 

 

 

 

y; to compare

 

 

 

unstable

 

 

 

 

 

 

 

both drugs in

 

 

 

patients and

 

 

 

 

 

 

 

the

 

 

 

those with

 

 

 

 

 

 

 

prevention of

 

 

 

VAD and/or

 

 

 

 

 

 

 

nonsurgical

 

 

 

requiring

 

 

 

 

 

 

 

infections,

 

 

 

IABPs,

 

 

 

 

 

 

 

noninfectious

 

 

 

transplant, or

 

 

 

 

 

 

 

complications

 

 

 

total artificial

 

 

 

 

 

 

 

, and

 

 

 

hearts were

 

 

 

 

 

 

 

mortality at

 

 

 

not enrolled.

 

 

 

 

 

 

 

discharge, 1

 

 

 

Patients who

 

 

 

 

 

 

 

mo, and 6 mo

 

 

 

had received

 

 

 

 

 

 

 

after the

 

 

 

systemic

 

 

 

 

 

 

 

operation; to

 

 

 

antibiotics in

 

 

 

 

 

 

 

compare the

 

 

 

the

 

 

 

 

 

 

 

microorganis

 

 

 

preoperative

 

 

 

 

 

 

 

ms

 

 

 

w and those

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

 

responsible

 

 

 

allergic to

 

 

 

 

 

 

 

for infections

 

 

 

glycopeptides

 

 

 

 

 

 

 

after

 

 

 

, penicillins,

 

 

 

 

 

 

 

operations;

 

 

 

or

 

 

 

 

 

 

 

and to

 

 

 

cephalosporin

 

 

 

 

 

 

 

compare the

 

 

 

s were not

 

 

 

 

 

 

 

safety of the

 

 

 

eligible.

 

 

 

 

 

 

 

2 drugs.

 

 

 

Active

 

 

 

 

 

 

 

 

 

 

 

bacterial

 

 

 

 

 

 

 

 

 

 

 

infections

 

 

 

 

 

 

 

 

 

 

 

precluded

 

 

 

 

 

 

 

 

 

 

 

entry into the

 

 

 

 

 

 

 

 

 

 

 

study, but

 

 

 

 

 

 

 

 

 

 

 

asymptomatic

 

 

 

 

 

 

 

 

 

 

 

bacteriuria

 

 

 

 

 

 

 

 

 

 

 

was allowed.

 

 

 

 

 

 

 

 

 

 

 

Patients with

 

 

 

 

 

 

 

 

 

 

 

serum

 

 

 

 

 

 

 

 

 

 

 

creatinine

 

 

 

 

 

 

 

 

 

 

 

levels of 250

 

 

 

 

 

 

 

 

 

 

 

µmol/L or

 

 

 

 

 

 

 

 

 

 

 

more (2.8

 

 

 

 

 

 

 

 

 

 

 

mg/dL) or

 

 

 

 

 

 

 

 

 

 

 

neutropenia

 

 

 

 

 

 

 

 

 

 

 

of 1,000

 

 

 

 

 

 

 

 

 

 

 

cells/mm ≤3

 

 

 

 

 

 

 

 

 

 

 

were

 

 

 

 

 

 

 

 

 

 

 

excluded. Use

 

 

 

 

 

 

 

 

 

 

 

of an

 

 

 

 

 

 

 

 

 

 

 

investigationa

 

 

 

 

 

 

 

 

 

 

 

l drug or

 

 

 

 

 

 

 

 

 

 

 

device in the

 

 

 

 

 

 

 

 

 

 

 

30 d before

 

 

 

 

 

 

 

 

 

 

 

the operation

 

 

 

 

 

 

 

 

 

 

 

was not

 

 

 

 

 

 

 

 

 

 

 

allowed nor

 

 

 

 

 

 

 

 

 

 

 

was prior

 

 

 

 

 

 

 

 

 

 

 

participation

 

 

 

 

 

 

 

 

 

 

 

in a trial with

 

 

 

 

 

 

 

 

 

 

 

teicoplanin.

 

 

 

 

 

 

 

 

 

 

 

Patients of

 

 

 

 

 

 

 

 

 

 

 

mental

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

 

 

 

 

 

capacity so

 

 

 

 

 

 

 

 

 

 

 

limited as to

 

 

 

 

 

 

 

 

 

 

 

preclude

 

 

 

 

 

 

 

 

 

 

 

informed

 

 

 

 

 

 

 

 

 

 

 

consent were

 

 

 

 

 

 

 

 

 

 

 

not enrolled.

 

 

 

 

 

 

Ceftriaxone

This study

RCT

200

All patients

Patients with

Overall rate of

N/A

The overall

NS

N/A

The findings of this study

versus

compared the

 

 

undergoing

serum

infections

 

infection rate

 

 

support the adequacy of a

vancomycin

efficacy of

 

 

elective heart

creatinine

(wound

 

was 13.4% in

 

 

simple single dose of

prophylaxis in

this narrow-

 

 

surgery

levels higher

infections,

 

the ceftriaxone

 

 

ceftriaxone prophylaxis in

CV surgery.

spectrum

 

 

 

than 17 mg/L

mediastinitis,

 

and 10.7% in

 

 

cardiac surgery, at least in

1999 (248)

glycopeptide

 

 

 

were

asymptomatic

 

the vancomycin

 

 

hospitals with low incidence

 

4 with a

 

 

 

excluded.

bacteriuria,

 

group. 4 (4%)

 

 

of vancomycin-resistant

 

single dose of

 

 

 

 

respiratory

 

wound

 

 

staphylococcal infections.

 

ceftriaxone.

 

 

 

 

infections)

 

infections,

 

 

 

 

 

 

 

 

 

 

 

including one

 

 

 

 

 

 

 

 

 

 

 

mediastinitis,

 

 

 

 

 

 

 

 

 

 

 

occurred in the

 

 

 

 

 

 

 

 

 

 

 

ceftriaxone

 

 

 

 

 

 

 

 

 

 

 

group and 5

 

 

 

 

 

 

 

 

 

 

 

(5%) in the

 

 

 

 

 

 

 

 

 

 

 

vancomycin

 

 

 

 

 

 

 

 

 

 

 

group, with no

 

 

 

 

 

 

 

 

 

 

 

statistically

 

 

 

 

 

 

 

 

 

 

 

significant

 

 

 

 

 

 

 

 

 

 

 

difference.

 

 

 

Comparison of

To

RCT

884

All patients

Patients with

Rate of in-

N/A

The overall

NS

difference between proportions -

The data suggest that

vancomycin

investigate

 

 

scheduled for

a known

hospital and

 

immediate SSI

 

0.3 (95% CI: -2.6 to 2.1)

vancomycin has no

and cefuroxime

clinically

 

 

CABG without

allergy to

late (1 mo) SSI

 

rate was 3.2%

 

 

clinically significant

for infection

significant

 

 

valvular surgery

cephalosporin

 

 

in the

 

 

advantages over

prophylaxis in

differences

 

 

 

os or

 

 

cefuroxime

 

 

cephalosporin in terms of

coronary artery

between

 

 

 

vancomycin,

 

 

group and 3.5%

 

 

antimicrobial prophylaxis.

bypass surgery.

vancomycin

 

 

 

an active

 

 

in the

 

 

We suggest that cefuroxime

1998 (249)

and

 

 

 

infection, or

 

 

vancomycin

 

 

(or first-generation

 

cefuroxime

 

 

 

who had

 

 

group

 

 

cephalosporins, which were

 

for

 

 

 

received

 

 

(difference, -

 

 

not studied here) is a good

 

perioperative

 

 

 

prescribed

 

 

0.3; 95% CI: -

 

 

choice for infection

 

infection

 

 

 

antibiotic

 

 

2.6 to 2.1).

 

 

prophylaxis in connection

 

prophylaxis

 

 

 

within the

 

 

 

 

 

with CABG in institutions

 

in CABG.

 

 

 

previous 2

 

 

 

 

 

without methicillin-resistant

 

 

 

 

 

wk, were

 

 

 

 

 

Staphylococcus aureus

 

 

 

 

 

excluded, as

 

 

 

 

 

problems. In addition to the

© American College of Cardiology Foundation and American Heart Association, Inc.

 

 

 

 

 

were patients

 

 

 

 

 

increasing vancomycin-

 

 

 

 

 

undergoing a

 

 

 

 

 

resistant enterococci

 

 

 

 

 

repeat bypass

 

 

 

 

 

problem, the easier

 

 

 

 

 

 

 

 

 

 

 

administration and usually

 

 

 

 

 

 

 

 

 

 

 

lower price of cefuroxime

 

 

 

 

 

 

 

 

 

 

 

make it preferable to

 

 

 

 

 

 

 

 

 

 

 

vancomycin.

Antibiotic

In this present

RCT (2

Trial 1:

All patients

Exclusion

Wound scores

Rates of

Teicoplanin

p<0.01

N/A

In the first trial, teicoplanin

prophylaxis in

study, the

trials in 1

314;

undergoing

criteria of age

 

bacteremia,

prophylaxis

 

 

(400 mg on induction of

cardiac surgery:

development

paper)

Trial 2:

cardiac surgery

under 18 y,

 

respiratory

resulted in a

 

 

anaesthesia and 200 mg 24 h

a prospective

of wound

 

203

involving CPB

pregnancy,

 

and urinary

significantly

 

 

later), was compared with

comparison of 2

infection

 

 

were to be

history of

 

infections

greater number

 

 

tobramycin and

dosage

following

 

 

considered for the

allergy to

 

 

of sternal

 

 

flucloxacillin. Gram-

regimens of

cardiac

 

 

trial.

penicillin or

 

 

wound

 

 

negative bacteria were

teicoplanin with

surgery has

 

 

 

vancomycin,

 

 

infections

 

 

responsible for more

a combination

been

 

 

 

serum

 

 

(p<0.01), due to

 

 

respiratory and urinary

of flucloxacillin

examined

 

 

 

creatinine

 

 

gram-positive

 

 

infections after teicoplanin

and tobramycin.

with a scoring

 

 

 

over

 

 

bacteria. In the

 

 

prophylaxis.

1998 (250)

method that

 

 

 

150/onol/l,

 

 

second trial the

 

 

 

 

measures the

 

 

 

active

 

 

teicoplanin dose

 

 

 

 

clinical

 

 

 

infection or

 

 

regimen was

 

 

 

 

appearance of

 

 

 

antibiotic

 

 

changed to

 

 

 

 

the wound

 

 

 

treatment

 

 

three doses of

 

 

 

 

and any

 

 

 

within the last

 

 

400 mg but this

 

 

 

 

changes in

 

 

 

7 d, were

 

 

did not improve

 

 

 

 

management

 

 

 

agreed.

 

 

the rates of

 

 

 

 

related to

 

 

 

Midstream

 

 

infection.

 

 

 

 

infection. In

 

 

 

urine

 

 

 

 

 

 

 

the paper

 

 

 

specimens

 

 

 

 

 

 

 

there are 2

 

 

 

would be

 

 

 

 

 

 

 

trials

 

 

 

taken

 

 

 

 

 

 

 

described,

 

 

 

preoperativel

 

 

 

 

 

 

 

both

 

 

 

y and patients

 

 

 

 

 

 

 

compared

 

 

 

with more

 

 

 

 

 

 

 

different

 

 

 

than 10^5

 

 

 

 

 

 

 

regimens of

 

 

 

Gramnegative

 

 

 

 

 

 

 

teicoplanin

 

 

 

bacteria per

 

 

 

 

 

 

 

vs.

 

 

 

ml of urine

 

 

 

 

 

 

 

fluclocsacillin

 

 

 

were to be

 

 

 

 

 

 

 

+tobramycin.

 

 

 

excluded

 

 

 

 

 

 

 

 

 

 

 

unless a

 

 

 

 

 

 

 

 

 

 

 

repeat

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

 

 

 

 

 

 

 

 

 

 

 

 

specimen was

 

 

 

 

 

 

 

 

 

 

 

shown to be

 

 

 

 

 

 

 

 

 

 

 

sterile.

 

 

 

 

 

 

Intraoperative

To compare 2

RCT

58

Adult patients

Valvular

The rate and

Hemodynami

In the

p<0.01

Not reported

The results show that a

and

surgical

 

 

requiring elective

heart disease

frequency of

c data

vancomycin

 

 

significantly greater number

postoperative

population

 

 

CABG

requiring

norepinephrine

 

group, 50% of

 

 

of patients who received

effects of

randomized

 

 

 

surgical

infusions

 

patients

 

 

vancomycin required a

vancomycin

to receive

 

 

 

repair or

 

 

received a

 

 

norepinephrine infusion and

administration

antibiotic

 

 

 

replacement,

 

 

norepinephrine

 

 

that, despite norepinephrine

in cardiac

prophylaxis

 

 

 

a history of

 

 

infusion in the

 

 

infusion therapy, systemic

surgery

consisting of

 

 

 

prior open-

 

 

intraoperative

 

 

vascular resistance was not

patients: a

either

 

 

 

heart surgery,

 

 

and/or

 

 

normalized in this group of

prospective,

cefazolin or

 

 

 

LVEF of

 

 

postoperative

 

 

patients. The study supports

double-blind,

both cefasolin

 

 

 

<0.4,

 

 

period as

 

 

the conclusion that

randomized

and

 

 

 

emergency

 

 

compared with

 

 

perioperative administration

trial. 1993 (251)

vancomycin.

 

 

 

surgery,

 

 

14% in the

 

 

of vancomycin in cardiac

 

In these

 

 

 

chronic renal

 

 

normal saline

 

 

surgery patients may result

 

groups

 

 

 

insufficiency

 

 

group (p<0.01).

 

 

in hypotension requiring the

 

norepinephrin

 

 

 

(creatinine of

 

 

 

 

 

use of a vasopressor in an

 

use was

 

 

 

>1.8 mg/dL)

 

 

 

 

 

attempt to normalize

 

compared.

 

 

 

or renal

 

 

 

 

 

hemodynamic indices.

 

 

 

 

 

failure, a

 

 

 

 

 

 

 

 

 

 

 

history of

 

 

 

 

 

 

 

 

 

 

 

allergic or

 

 

 

 

 

 

 

 

 

 

 

adverse

 

 

 

 

 

 

 

 

 

 

 

reaction to

 

 

 

 

 

 

 

 

 

 

 

cephalosporin

 

 

 

 

 

 

 

 

 

 

 

antibiotics or

 

 

 

 

 

 

 

 

 

 

 

vancomycin,

 

 

 

 

 

 

 

 

 

 

 

chronic

 

 

 

 

 

 

 

 

 

 

 

administratio

 

 

 

 

 

 

 

 

 

 

 

n of calcium

 

 

 

 

 

 

 

 

 

 

 

entry

 

 

 

 

 

 

 

 

 

 

 

blockers (due

 

 

 

 

 

 

 

 

 

 

 

to effects on

 

 

 

 

 

 

 

 

 

 

 

the peripheral

 

 

 

 

 

 

 

 

 

 

 

vascular

 

 

 

 

 

 

 

 

 

 

 

system),

 

 

 

 

 

 

 

 

 

 

 

pregnancy,

 

 

 

 

 

 

 

 

 

 

 

prisoners, and

 

 

 

 

 

 

 

 

 

 

 

the mentally

 

 

 

 

 

 

 

 

 

 

 

impaired.

 

 

 

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

 

 

 

 

 

 

 

Clinical trial of

To compare 3

RCT

1,641

N/A

N/A

Number of

The depth of

Of the 1,641

NS

N/A

Because no differences in

cefamandole,

cephalosporin

 

 

 

 

sites of

tissue

participants,

 

 

effectiveness in preventing

cefazolin, and

s (cefazolin,

 

 

 

 

infection

involvement

141 (8.6%) had

 

 

postoperative site infections

cefuroxime for

cefamandole,

 

 

 

 

 

 

≥1 operative

 

 

were demonstrated in a

antibiotic

cefuroxime)

 

 

 

 

 

 

site infections:

 

 

rigorously designed trial, the

prophylaxis in

for antibiotic

 

 

 

 

 

 

46 of 549

 

 

costs of the drugs, including

cardiac

prophylaxis

 

 

 

 

 

 

(8.4%)

 

 

the costs of their preparation

operations.

in cardiac

 

 

 

 

 

 

cefamandole

 

 

and delivery, may be the

1993 (252)

surgery.

 

 

 

 

 

 

recipients, 46 of

 

 

only variables by which to

 

 

 

 

 

 

 

 

547 (8.4%)

 

 

choose among these 3

 

 

 

 

 

 

 

 

cefazolin

 

 

antibiotic prophylaxis

 

 

 

 

 

 

 

 

recipients, and

 

 

regimens.

 

 

 

 

 

 

 

 

49 of 545

 

 

 

 

 

 

 

 

 

 

 

(9.0%)

 

 

 

 

 

 

 

 

 

 

 

cefuroxime

 

 

 

 

 

 

 

 

 

 

 

recipients

 

 

 

 

 

 

 

 

 

 

 

(p=0.92). The

 

 

 

 

 

 

 

 

 

 

 

sites of

 

 

 

 

 

 

 

 

 

 

 

infection and

 

 

 

 

 

 

 

 

 

 

 

the depth of

 

 

 

 

 

 

 

 

 

 

 

tissue

 

 

 

 

 

 

 

 

 

 

 

involvement

 

 

 

 

 

 

 

 

 

 

 

were NS

 

 

 

 

 

 

 

 

 

 

 

different across

 

 

 

 

 

 

 

 

 

 

 

groups.

 

 

 

Efficacy of

To compare

RCT

1,030

All adult patients

Patients who

Sternal and

Cost of

Patients

p<0.02

N/A

These data suggest that ,

cefazolin,

cefazolin vs

 

 

scheduled for

received

donor site

hospitalizatio

receiving

(sternal

 

compared with

cefamandole,

cefamandole

 

 

elective median

antibiotics or

infection rates

n

cefamandole-

wound

 

cefamandole, cefazolin

and gentamicin

for antibiotic

 

 

sternotomy

patients with

 

 

gentamicin had

infection

 

offers unreliable

as prophylactic

prophylaxis

 

 

incision who

infections

 

 

a significantly

rate with

 

prophylaxis against deep

agents in

in cardiac

 

 

were free of

 

 

 

lower sternal

gentamici

 

infection at both the sternal

cardiac surgery.

surgery.

 

 

infection and not

 

 

 

wound infection

n added),

 

and donor sites, and that

Results of a

 

 

 

receiving any

 

 

 

rate than those

p<0.05

 

gentamicin has no role as a

prospective,

 

 

 

therapeutic

 

 

 

receiving

(sternal

 

prophylactic antibiotic in

randomized,

 

 

 

antibiotics were

 

 

 

cefazolin-

wound

 

cardiac surgery.

double-blind

 

 

 

considered

 

 

 

gentamicin (0%

infection

 

 

trial in 1,030

 

 

 

eligible for

 

 

 

and 2.4%,

rate with

 

 

patients (253).

 

 

 

inclusion in the

 

 

 

respectively;

or without

 

 

 

 

 

 

study.

 

 

 

p<0.02).

gentamici

 

 

 

 

 

 

 

 

 

 

Patients

n), p<0.02

 

 

 

 

 

 

 

 

 

 

receiving

(donor site

 

 

 

 

 

 

 

 

 

 

cefamandole

infection

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.

 

 

 

 

 

 

 

 

with or without

rate with

 

 

 

 

 

 

 

 

 

 

gentamicin had

or without

 

 

 

 

 

 

 

 

 

 

a significantly

gentamici

 

 

 

 

 

 

 

 

 

 

lower infection

n)

 

 

 

 

 

 

 

 

 

 

rate than

 

 

 

 

 

 

 

 

 

 

 

patients

 

 

 

 

 

 

 

 

 

 

 

receiving

 

 

 

 

 

 

 

 

 

 

 

cefazolin with

 

 

 

 

 

 

 

 

 

 

 

or without

 

 

 

 

 

 

 

 

 

 

 

gentamicin at

 

 

 

 

 

 

 

 

 

 

 

both the sternal

 

 

 

 

 

 

 

 

 

 

 

(0.4% vs. 1.8%,

 

 

 

 

 

 

 

 

 

 

 

p<0.05) and

 

 

 

 

 

 

 

 

 

 

 

donor sites (0%

 

 

 

 

 

 

 

 

 

 

 

vs.1.3%,

 

 

 

 

 

 

 

 

 

 

 

p<0.02).

 

 

 

CABG indicates coronary artery bypass graft; CI, confidence interval; CPB, cardiopulmonary bypass; CV, cardiovascular; d, day; DSWI, deep sternal wound infection; HR, hazard ratio; IABP, intra aortic balloon pump; LVEF, left ventricular ejection fraction; mon, month; N/A, not applicable; NS, non-significant; OR, odds ratio; RCT, randomized controlled trial; RR, relative risk; SSI, surgical site infection; UTI, urinary tract infection; and VAD, ventricular assist device.

Data Supplement 37. Renal Dysfunction

Article Title

Aim of Study

Study

Study

Patient Population/Inclusion &

Endpoints

Statistical Analysis

P-Values

OR / HR /

Study Summary

 

 

Type

Size

Exclusion Criteria

 

 

Reported

& 95% CI

RR

 

 

 

 

 

Inclusion Criteria

Exclusion

Primary

Secondary

 

 

 

 

 

 

 

 

 

Criteria

Endpoint

Endpoint

 

 

 

 

Efficacy of

To assess the

Systemat

1,163

RCTs of adults

 

Incidence of ARI

Maximum change

Compared with

p=0.24

RR: 0.91;

 

NAC in

potential

ic review

 

undergoing cardiac

 

 

in serum

placebo, NAC did not

(incidence

95% CI:

 

preventing

efficacy and

and

 

surgery, in which at

 

 

creatinine from

provide a statistically

of ARI)

0.79 to

 

renal injury

adverse effects

meta-

 

least 1 of the

 

 

baseline within 5 d

significant reduction

 

1.06

 

after heart

of

analysis

 

treatment groups

 

 

following surgery,

in any of the assessed

 

(incidence

 

surgery: a

perioperative

 

 

received NAC,

 

 

need for

outcomes. There was

 

of ARI)

NAC did not statistically reduce

systematic

NAC

 

 

administered orally

 

 

postoperative

no difference in the

 

 

the length of ICU or hospital

review of

administration

 

 

or intravenously,

 

 

haemodialysis, all-

incidence of ARI

 

 

stay. However, there was a trend

RCTs. 2009

in adults

 

 

immediately before,

 

 

cause mortality,

[35% NAC vs. 37%

 

 

towards reduced ARI incidence

(254)

undergoing

 

 

during, or

 

 

and LOS in the

placebo; RR: 0.91;

 

 

among patients with baseline

 

cardiac

 

 

immediately after

 

 

ICU and the

95% CI: 0.79 to 1.06;

 

 

CKD randomized to NAC (RR:

 

surgery.

 

 

cardiac surgery at

 

 

hospital.

p=0.24] or maximum

 

 

0.86; 95% CI: 0.70 to1.05;

 

 

 

 

any dose, for any

 

 

 

change in serum

 

 

p=0.14), particularly if NAC

 

 

 

 

length of time, with

 

 

 

creatinine from

 

 

preparations were administered

 

 

 

 

reported

 

 

 

baseline (0.32 mg/dL

 

 

intravenously (RR: 0.80; 95%

 

 

 

 

preoperative

 

 

 

±0.51 vs. 0.32 mg/dL

 

 

CI: 0.64 to 1.01; p=0.06).

© American College of Cardiology Foundation and American Heart Association, Inc.

 

 

 

 

(baseline) and

 

 

 

±0.47; p=0.95).

 

 

 

 

 

 

 

postoperative (within

 

 

 

Overall, 3.3% of

 

 

 

 

 

 

 

5 d after surgery)

 

 

 

patients required

 

 

 

 

 

 

 

creatinine levels or

 

 

 

haemodialysis (NAC

 

 

 

 

 

 

 

the incidence of ARI

 

 

 

vs. placebo; RR: 1.13;

 

 

 

 

 

 

 

after heart surgery in

 

 

 

95% CI: 0.59 to 2.17)

 

 

 

 

 

 

 

each treatment group

 

 

 

and 3% of patients

 

 

 

 

 

 

 

were included.

 

 

 

died (RR: 1.10; 95%

 

 

 

 

 

 

 

 

 

 

 

CI: 0.56 to 2.16).

 

 

 

Effect of

To evaluate

RCT

100

Patients undergoing

Exclusion

The mean

The rate of MI (as

N/A

p=NS

N/A

No differences were noted in the

intravenous

the effects of

 

 

primary CABG with

criteria were

postoperative

defined by CK-

 

 

 

incidence of renal dysfunction

NAC on

intravenous

 

 

CPB

emergency

release of cardiac

MB level >50

 

 

 

over a 4-d period after CPB

outcomes

NAC on

 

 

 

operations,

troponin T levels

and/or new Q

 

 

 

comparing NAC-group and

after CABG:

clinical and

 

 

 

acute MI within

between the 2

wave on

 

 

 

placebo-group.

a

biochemical

 

 

 

<3 wk, prior

groups (1-, 2-, 4-

electrocardiogram

 

 

 

 

randomized,

outcomes after

 

 

 

cardiac surgery,

, 8-, 12-, and 24-

in a given

 

 

 

 

double-

CABG with

 

 

 

age >80 y,

h

territory), renal

 

 

 

 

blind,

CPB.

 

 

 

EF<20%, and

postoperatively,

function

 

 

 

 

placebo-

 

 

 

 

concomitant

then 2-, 3-, and

(creatinine),

 

 

 

 

controlled

 

 

 

 

procedures.

4-d

bleeding, low

 

 

 

 

clinical trial.

 

 

 

 

 

postoperatively)

cardiac output

 

 

 

 

2007 (255)

 

 

 

 

 

 

syndromes,

 

 

 

 

 

 

 

 

 

 

 

arrhythmias, and

 

 

 

 

 

 

 

 

 

 

 

mean levels of

 

 

 

 

 

 

 

 

 

 

 

CK-MB.

 

 

 

 

Phase II,

To assess the

RCT

60

Patients at high-risk

Exclusion

The absolute

The relative

There was no

p=NS

N/A

There was no evidence for

randomized,

effect of high-

 

 

of postoperative

criteria were

change in serum

change in serum

significant attenuation

 

 

differences in any other clinical

controlled

dose NAC on

 

 

renal dysfunction

age <18,

creatinine from

creatinine, the

in the increase in

 

 

outcome.

trial of high-

renal function

 

 

(age >70, preexisting

allergy or

baseline to peak

peak serum

serum creatinine from

 

 

 

dose NAC

in cardiac

 

 

renal impairment,

hypersensitivity

level within the

creatinine, the

baseline to peak when

 

 

 

in high-risk

surgery

 

 

NYHA 3/4, valve

to NAC,

first 5

absolute and

comparing NAC with

 

 

 

cardiac

patients at

 

 

surgery or complex

emergency

postoperative d.

relative change in

placebo (64.5±91.2

 

 

 

surgery

higher risk of

 

 

surgery, redo cardiac

operations,

 

serum cystatin C,

and 38.0±42.4

 

 

 

patients.

postoperative

 

 

surgery, insulin-

planned off-

 

and the urinary

mumol/L,

 

 

 

2007 (256)

renal failure

 

 

dependent diabetes

pump surgery,

 

output (to

respectively; p=0.15).

 

 

 

 

 

 

 

mellitus) who were

enrolled in

 

calculate the AKI

Also, there was no

 

 

 

 

 

 

 

scheduled for

conflicting

 

rate), the use of

attenuation in the

 

 

 

 

 

 

 

elective or urgent

study. Known

 

renal replacement

increase in serum

 

 

 

 

 

 

 

cardiac surgery

blood-born

 

therapy, duration

cystatin C from

 

 

 

 

 

 

 

necessitating the use

infectious

 

of ventilation,

baseline to peak for

 

 

 

 

 

 

 

of CPB at 2 tertiary

disease, chronic

 

chest tube

NAC compared with

 

 

 

 

 

 

 

referral hospitals.

inflammatory

 

drainage, need for

placebo (0.45±0.43

 

 

 

© American College of Cardiology Foundation and American Heart Association, Inc.