OBJECTIVE: In a previous non-randomized study, we demonstrated that no difference occurred in the rate of acquisition of bacteriuria between a complex closed drainage system (CCDS) and a two-chamber drainage system (TCDS) in patients in an intensive care unit (ICU). To confirm this result, we performed a randomized, prospective, and powerful study assessing the effectiveness of the CCDS and the TCDS in ICU patients. DESIGN: Randomized, prospective, and controlled study. SETTING: Medico-surgical intensive care unit (16 beds) in a teaching hospital. PATIENTS AND INTERVENTIONS: Three hundred and eleven patients requiring an indwelling urinary catheter for longer than 48 h were assigned individuals to the TCDS group or CCDS group to compare the rate of acquisition of bacteriuria. MEASUREMENTS AND RESULTS: Patients did not receive prophylactic antibiotics during placement management or catheter withdrawal. 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. There was no statistical difference in the rate of bacteriuria between the two groups. Bacteriuria occurred in 8% and 8.5% of patients for TCDS and CCDS, respectively. Rates of urinary tract infection were 12.1 and 12.8 episodes per 1,000 days of catheter. CONCLUSION: This randomized study, that compares the effectiveness of a TCDS and a CCDS in ICU patients, confirms the results of our previous study. No differences were noted between the two systems (a =0.05). The higher cost of CCDS is not justified for ICU patients.
RCT Entities:
OBJECTIVE: In a previous non-randomized study, we demonstrated that no difference occurred in the rate of acquisition of bacteriuria between a complex closed drainage system (CCDS) and a two-chamber drainage system (TCDS) in patients in an intensive care unit (ICU). To confirm this result, we performed a randomized, prospective, and powerful study assessing the effectiveness of the CCDS and the TCDS in ICU patients. DESIGN: Randomized, prospective, and controlled study. SETTING: Medico-surgical intensive care unit (16 beds) in a teaching hospital. PATIENTS AND INTERVENTIONS: Three hundred and eleven patients requiring an indwelling urinary catheter for longer than 48 h were assigned individuals to the TCDS group or CCDS group to compare the rate of acquisition of bacteriuria. MEASUREMENTS AND RESULTS:Patients did not receive prophylactic antibiotics during placement management or catheter withdrawal. 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. There was no statistical difference in the rate of bacteriuria between the two groups. Bacteriuria occurred in 8% and 8.5% of patients for TCDS and CCDS, respectively. Rates of urinary tract infection were 12.1 and 12.8 episodes per 1,000 days of catheter. CONCLUSION: This randomized study, that compares the effectiveness of a TCDS and a CCDS in ICU patients, confirms the results of our previous study. No differences were noted between the two systems (a =0.05). The higher cost of CCDS is not justified for ICU patients.
Authors: Marc Leone; Anne-Sophie Perrin; Isabelle Granier; Pierre Visintini; Valery Blasco; François Antonini; Jacques Albanèse; Claude Martin Journal: Intensive Care Med Date: 2007-02-09 Impact factor: 17.440