INTENSIV-News
Randomized, controlled trial of selective digestive
decontamination in 600 mechanically ventilated patients in a
multidisciplinary intensive care unit
Charles Verwaest, Jan Verhaegen, Patrick Ferdinande, et al. Crit Care Med 1997; 25:63-71
OBJECTIVE:
To evalute the efficacy of two regimens of selective decontamination of
the digestive tract in mechanically ventilated patients.
DESIGN: Prospective, randomized, concurrent trial.
SETTING: Multidisciplinary intensive care unit (ICU) in a 1,800-bed university hospital.
PATIENTS:
Consecutive patients (n=660) who were likely to require mechanical
ventilation for at least 48 hrs were randomized to one of three groups:
conventional antibiotic regimen (control group A); oral and enteral
ofloxacin-amphotericin B (group B); and oral and enteral polymyxin
E-tobramycin-amphotericon B (group C). Both treatment groups received
systematic antibiotics for 4 days (ofloxacin in group B and cefotaxime
in group C).
INTERVENTIONS: Patients were randomized to receive
standard treatment (control croup A, n = 220), selective decontamination
regimen B (group B, n = 220), and selective decontamination regimen C
(group C, n = 220). After early deaths and exclusions from the study,
185 controls (group A) and 193 (group B)/200 (group C) selective
decontamination regimen patients were available for analysis.
MEASUREMENTS
AND MAIN RESULTS: Measurements included colonization and
primary/secondary infection rate, ICU mortality rate, emergence of
antibiotic resistance, length of ICU stay, and antimicrobial agent
costs. The study duration was 19 months. The patient groups were fully
comparable for age, diagnostic category, and severity of illness. One
third of patients in each group suffered a nosocomial infection at the
time of admission. There was a significant difference between treatment
group B and control group A in the number of infected patients (odds
ratio of 0.42,95% confidence interval of 0.27 to 0.64), secondary lower
respiratory tract infection (odds ratio of 0.47, 95% confidence interval
of 0.26 to 0.82), and urinary tract infection (odds ratio of 0.47, 95%
confidence interval of 0.27 to 0.81). Significantly more Gram-positive
bacteremias occurred in treatment group C vs. group A (odds ratio of
1.22, 95% confidence interval 0.72 to 2.08). Infection at the time of
admission proved to be the most significant risk factor for subsequent
infection in control and both treatment groups. ICU mortality rate was
almost identical (group A 16,8%, group B 17,6%, and group C 15,5%) and
was not significantly related to primary or secondary infection.
Increased antimicrobial resistance was recorded in both treatment
groups: tobramycin-resistant enterobacteriaceae (group C 48% vs. group A
14%, p < .01), ofloxacin-resistant enterobacteriaceae (group B 50%
vs. group A 11%, p < .02), ofloxacin-resistant nonfermenters (group B
81% vs. group A 52%, p < .02), and methicillin-resistant
Staphylococcus aureus (group C 83% vs. group A 55%, p < .05).
Antimicrobial agent costs were comparable in control and group C
patients; one third less was spent for group B patients.
CONCLUSIONS:
In cases of high coloniziation and infection rates at the time of ICU
admission, the preventive benefit of selective decontamination is highly
debatable. Emergence of multiple antibiotic-resistant microorganisms
creates a clinical problem and a definite change in the ecology of
environmental, colonizing, and infecting bacteria. The selection of
multiple antibiotic-resistant Gram-positive cocci is particularly
hazardous. No beneficial effect on survival is observed. Moreover,
selective decontamination adds substantially to the cost of ICU care.
Anfang der achtziger Jahre stellten Stoutenbeek und Mitarbeiter das Konzept der "selektiven Dekontamination des Digestionstrakes (SDD)” bei Intensivpatienten vor. Ziel dieser Behandlung war es, mit enteraler Verabreichung von drei antimikrobiellen Substanzen (Polymyxin E, Tobramycin und Amphotericin B) und enteraler Applikation von Cefotaxim während der ersten 4 Tage, eine Reduktion von nosokomialen Infektionen und der Sterblichkeit zu erzielen. Die anfangs publizierten Daten waren durchaus ermutigend und zeigten durchwegs signifikate Resultate hinsichtlich Reduktion der Pneumonierate und es gab kaum eine Intensivstation, auf der nicht irgendeine Form der SDD zumindest kurzfristig versucht wurde. Letztlich gelang es aber keiner Studie einen klinisch relevanten und statistisch signifikanten Einfluß der SDD auf Mortalität und Liegedauer der Intensivpatienten nachzuweisen. Deshalb wurden Meta-Analysen mehrerer Studien angestellt, die allerdings auch keinen durchschlagenden Effekt der SDD zeigen konnten. Die vorliegende Studie von Verwaest und Mitarbeitern vergleicht eine Kontrollgruppe mit einer moderneren bzw. der ursprünglichen Variante der SDD.
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