(Chest. 2001;120:220-224.)
© 2001
American College of Chest Physicians
Prevention of Nosocomial Urinary Tract Infection in ICU Patients*
Comparison of Effectiveness of Two Urinary Drainage Systems
Marc Leone, MD;
Franck Garnier, MD;
Myriam Dubuc, MD;
Marie Christine Bimar, MD and
Claude Martin, MD, FCCP
*
From the Intensive Care Unit and Trauma Center (Drs. Leone, Garnier, Bimar, and Martin), and Department of Biostatistics (Dr. Dubuc), Nord Hospital, Marseilles University Hospital System, Marseilles School of Medicine, Marseilles, France.
Correspondence to: Marc Leone, MD, Service de Réanimation Polyvalente, Hôpital Nord, 13915 Marseille Cédex 1, France; e-mail: mleone{at}mail.ap-hm.fr
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Abstract
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Study objectives: To determine whether the rate of
acquisition of bacteriuria differs between the use of a complex closed
drainage system (CCDS) with a preattached catheter, antireflux valve,
drip chamber, and povidone-iodine releasing cartridge, and a
two-chamber open drainage system (TCOS) in ICU patients.
Design: Prospective, nonrandomized, controlled trial.
Setting: Medical/surgical/trauma ICU in a university
hospital.
Patients: Two hundred twenty-four ICU
patients requiring an indwelling urinary catheter.
Intervention: We compared the rate of acquisition of
bacteriuria in two groups of consecutive patients (n = 113 and
n = 111, respectively) who underwent bladder catheterization with a
TCOS during the first 6 months and with a CCDS during the next 6
months. Urinary catheters were managed by a team of trained nurses
following the same written protocol. No prophylactic antibiotics were
administered, either during management of catheter placements or
catheter withdrawal, but 75% of patients received one or more
antimicrobial medications for treatment of infected sites other than
the urinary tract. Urine samples were obtained weekly for the duration
of catheterization and within 24 h after catheter removal, and
each time symptoms of urinary infection were suspected. Only patients
who required an indwelling catheter for > 48 h were evaluated.
Measurements and results: There was no statistical
difference in the rate of bacteriuria between the two groups.
Bacteriuria occurred in 11.5% and 13.5% of patients, and was
diagnosed on day 14 ± 8 and 13 ± 9 of catheterization
(mean ± SD) for the TCOS and the CCDS, respectively. A CCDS cost $3
(US dollars) more than the TCOS.
Conclusions: To our
knowledge, this is the first study to compare the effectiveness of a
TCOS and a CCDS in ICU patients. No differences were noted between the
two systems (
= 0.05). The higher cost of a CCDS is not justified
for ICU patients.
Key Words: bacteriuria • closed drainage system • ICU • urinary tract infection
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Introduction
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Urinary
tract infections are the second most common nosocomial infections in
ICUs in Europe1
and the first in the United
States.2
They may involve a urosepsis, which carries a
mortality rate that may be as high as 25 to 60%.3
They
often occur in patients with an indwelling urinary catheter. The lumen
and external surfaces of the catheter are the routes for bacterial
entry into the bladder. For preventing infection, the maintenance of a
closed sterile drainage system is described as the most successful
method.4
5
6
7
8
9
10
11
12
13
A closed drainage system was described for
the first time in 1928,4
and its benefit was appreciated
much later.5
6
7
8
ICUs are the place in the hospital where the most severely ill patients
are admitted, with the use of multiple invasive devices and frequent
prescription of broad-spectrum antimicrobial agents. For these reasons,
optimization of nursing-care procedures and adherence to antibiotic
prescription rules are strongly recommended for the control of
nosocomial infections. Most patients in these units require an
indwelling urinary catheter to monitor diuresis. A closed drainage
system is strongly recommended to prevent catheter-associated urinary
tract infections. However, to our knowledge, no comparative
trial comparing open and closed drainage systems has been conducted in
ICU patients.
The present study was designed to compare the rate of nosocomial
urinary tract infections in ICU patients catheterized with a
two-chamber open drainage system (TCOS) or a complex closed drainage
system (CCDS).
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Materials and Methods
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Trial Design
After obtaining informed consent from the patients or their next
of kin, and with the approval of the ethics committee of our
institution, all ICU patients requiring an indwelling urinary catheter
were included in the study. The study was carried out at Nord Hospital,
an 550-bed, tertiary-care center affiliated with the University of the
Mediterranean Sea. The 16-bed ICU admits medical, surgical, and trauma
patients. No patients were admitted for postoperative surveillance.
Only patients who required an indwelling urethral catheter for > 48 h
were evaluated. The study was done during two consecutive periods of 6
months each; during these two periods, a TCOS (January to June) and a
CCDS (July to December) were successively used without restrictions
regardless of the underlying illness or medications used. The
simplified acute physiology score (SAPS) II, which includes 17
variables (12 physiology, 1 age, 1 type of admission, and 3 underlying
disease), was used to provide an estimate of the
prognosis.14
No changes in the management of patients
occurred between these periods. The same written protocols for the
management of urinary catheters were followed, these protocols having
been implemented in the ICU 5 years ago. During the two consecutive
periods, only two new nurses were included in the team, during each
period.
Urine Drainage Systems
The two urinary drainage systems were a TCOS (Appareil pour la
diurèse ouverte, 964.00; Vygon; Ecouen, France; Fig 1 ) and a CCDS with an antireflux valve (Curity Infection Control System,
model 8120; Kendall Company; Boston, MA). The TCOS contains a Foley
catheter connected to an output-measure recipient and a urine
collection bag. The CCDS comprises a preconnected coated latex
catheter, a tamper-discouraging seal at the catheter-drainage tubing
junction, a drip chamber, an antireflux valve, a drainage bag vent, and
a povidone-iodine releasing cartridge at the drain port of the urine
collection bag.
Catheter Care
Catheterization and drainage system care were practiced by a
team of trained nurses according to the French National General
Guidelines and Intensive Care Recommendations.15
One aim
of these recommendations is to obtain a nontraumatic, sterile
catheterization. Careful attention is given to the drainage system,
limiting the duration of catheterization, disposing of the urine
accumulated in the collection bag, replacing a malfunctioning
collecting system, and keeping the system closed when a closed system
is used. The insertion of the indwelling urethral catheter was
performed after surgical hand washing, wearing sterile gloves, a face
mask and a cap, and using sterile drapes. Routine meatal and perineal
hygiene with povidone-iodine, water, and nonsterile gloves was
performed once daily or more if the perineal zone was soiled. The same
urinary drainage system was maintained for a given patient during the
whole study period.
Bacteriologic Analysis
A urine sample was obtained aseptically within 24 h of
catheter insertion, then weekly for the duration of catheterization,
and within 24 h after removal of the catheter and each time
symptoms of urinary infection were suspected.
A catheter-associated bacteriuria was defined as
105 cfu/mL with no more than two different
species of organisms, according to the Centers for Disease Control and
Prevention criteria.16
Patients with bacteria within
24 h of catheter insertion were excluded from the analysis
(n = 3).
Statistical Analysis
Data were analyzed on an intent-to-treat basis and are presented
as mean ± SD. The Mantel-Haenszel 
2
statistic was calculated for stratified analysis of occurrence of
infection between the two groups. Continuous variables were compared
using Student’s t test for normally distributed variables
and Wilcoxon’s rank sum test for nonnormally distributed variables. A
p < 0.05 was considered statistically significant.
Kaplan-Meier cumulative frequency of infection analysis was used to
assess differences between the TCOS group and the CCDS
group.17
The target sample size was 224 patients. This
number yields a power of 61% to detect a difference of 10%
between the CCDS and the TCOS ( = 5%).
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Results
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Population Characteristics
A total of 224 subjects was studied during the 12-month study
period, 113 in the TCOS group and 111 in the CCDS group. Both groups
were comparable in age, sex ratio, and SAPS II score (Table 1
).14
Use of antimicrobials was similar between the two
groups: 75% of patients received one or more antimicrobials for the
treatment of infected sites other than the urinary tract. The mean
duration of urinary catheterization was 8 ± 7 days in the TCOS group
and 9 ± 7 days in the CCDS group.
Bacteriuria
Catheter-associated bacteriuria occurred in 27 of 224 patients
(12%): 12 of 113 patients (11.5%) in the TCOS group and 15 of 111
patients (13.5%) in the CCDS group. There was no statistical
difference in the incidence of bacteriuria between the two groups.
Bacteriuria occurred on day 14 ± 8 of catheterization in the
TCOS group and day 13 ± 9 of catheterization in the CCDS group
(Table 2 ). Escherichia coli was
the most frequently isolated organism. Polymicrobial culture findings
occurred in two patients. The distribution and resistance of organisms
are shown in Table 3 . Duration of
catheterization (8 ± 7 days vs 19 ± 10 days in the TCOS group
[p < 0.05] and 10 ± 8 days vs 19 ± 10 days in the CCDS group
[p < 0.05]) and length of stay in the ICU (11.5 ± 9.5 days vs
25 ± 10 days in the TCOS group [p < 0.05] and 11 ± 9 vs
22 ± 9 days in the CCDS group) were found as risk factors of
bacteriuria. In both groups, the rate of bacteriuria was higher in
women than in men: 6 of 28 women (22%) vs 7 of 85 men (8%) in the
TCOS group (p < 0.05), and 6 of 28 women (22%) vs 9 of 83 men
(11%) in the CCDS group (p < 0.01). The distribution of episodes of
urinary tract infections with respect to the duration of
catheterization is shown in Figure 2 . No difference was found between the two groups (Fig 3
).
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Figure 3.. Kaplan-Meier curves demonstrating the lack of
difference between the two system of urinary drainage. The data of
uninfected patients were censored on catheter removal day. Comparisons
between the time distribution of both groups were performed by means of
the log rank (Mantel-Cox) test (p = 0.215).
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Discussion
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The main result from the present study is that no difference was
noted between the two systems of urine drainage in the rate of urinary
tract infections. The same risk factors for bacteriuria were found in
both groups: duration of catheterization, length of stay in the ICU,
and female gender.
Historically, "open systems" were large, uncapped glass
bottles. The drainage catheters were inserted into the glass bottles,
often below the level of urine. Urine was stagnant, and bacteria could
easily grow and ascend through the drainage catheter.5
The
open system that was tested in the present study was much more
sophisticated: the two-chamber design might prevent reflux of urine
from the drainage bag, but the system is open to the air, without a
plugged vent.
According to previous studies, a CCDS may not be more effective than
simpler systems for bacteriuria prevention. A randomized
study8
comparing a nonpreconnected drainage system vs a
preconnected drainage system showed the effectiveness of a preconnected
drainage system in a subgroup of patients who did not receive
antibiotic treatment, and these results were not confirmed by another
study9
with a comparable methodology and no difference
between the two groups. One study,13
comparing in
surgical patients a simple closed drainage system and a CCDS during the
first 5 days after catheter insertion, concluded that complex features
aimed at preventing intraluminal spread of bacteria did not reduce the
risk of urinary tract infection. These findings are at variance with
the results of a previous study11
that found a 6% rate of
bacteriuria with a CCDS vs 23% with a simple drainage system. The
difference between the two systems should vary from the level of care
provided by nurses in ICU, medical, or surgical wards, but this
hypothesis remains to be determined in carefully controlled randomized
studies.
A TCOS is a quite simple device, with no filter and a nonantireflux
valve between the three components of the system: Foley catheter,
output-measure recipient, and urine collection bag. A port without a
filter is opened when urine samples are needed. A CCDS with an
antireflux valve, a tamper-discouraging seal at the catheter-drainage
tubing junction, and the addition of hydrogen peroxide and
chlorhexidine to the drainage bag have failed to demonstrate
effectiveness in preventing catheter-associated bladder bacteriuria.
These processes add cost to catheter management and may cause a false
sense of security. Considering the weak rate of catheter-associated
bacteriuria in ICU, it may not be cost-effective to invest in an
expensive drainage system,18
as Degroot-Kosolcharoen et
al10
explain in a comparative study conducted in male
surgical and medical patients.
Based on our results, the higher cost for purchasing a CCDS is not
justified in all ICUs. One limitation of the present study is the
absence of randomization, but no changes occurred in the ICU during the
two consecutive periods. All nurses followed the same written protocols
that have been in use in the ICU for the last 5 years. In addition, the
distribution among medical, surgical, and trauma patients, age, sex,
and SAPS II14
was similar from the TCOS group to the CCDS
group.
In conclusion, to our knowledge, this is the first study to compare the
effectiveness of a TCOS and a CCDS in ICU patients. No differences were
noted between the two drainage systems: catheter-associated bacteriuria
occurs in 11.5% of patients with a TCOS and in 13.5% of patients with
a CCDS. The higher cost of a CCDS is not justified for patients
hospitalized in ICUs.
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Acknowledgements
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The authors thank the nurses of the ICU for their
constant effort to provide the best level of care to the patients. The
nurses should also be congratulated for their enthusiastic support
during the study period.
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Footnotes
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Abbreviations: CCDS = complex closed drainage
system; SAPS = simplified acute physiology score;
TCOS = two-chamber open drainage system
Received for publication January 28, 2000.
Accepted for publication November 28, 2000.
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Abstract
Introduction
