Impact of Continuous Venovenous Haemofiltration on Organ Failure During the Early Phase of Severe Sepsis

Phase 4

Completed

• Conditions: Bacteremia; Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections; Pneumonia, Bacterial; Shock, Septic; Sepsis

• Registration Number: NCT00406198
• Lead Sponsor: Hopital Lariboisière

Brief Summary

The impact of continuous veno-venous haemofiltration (CVVH) on sepsis-induced multiple organ failure severity is controversial. We thus sought to assess the effect of early application of haemofiltration on the degree of organ dysfunction and plasma cytokine levels in patients with severe sepsis or septic shock.

Detailed Description

prospective, randomized, open, multicentre study was performed between 1997 and 1999 in 16 French intensive care units. Patients were enrolled within 24 hours of development of the first organ failure related to a new septic insult. They were randomized to group 1 (HF), who received haemofiltration for a 96 hr period, or group 2 (C) who were managed conventionally. The primary end-point was the number, severity and duration of organ failures at 14 days, as evaluated by the SOFA score, on an intention-to-treat analysis. Strict guidelines were provided to perform continuous haemofiltration under the same conditions and objectives in all centres.

Study Timeline

• Study Start: 1997-03
• Study Completion: 1999-12
• Status Verified: 2006-11
• Study First Submitted: 2006-11-30
• Study First Submitted QC: 2006-12-01
• Last Update Submitted: 2006-12-01
• Study First Posted: 2006-12-04
• Last Update Posted: 2006-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• clinically identified focus of infection associated with at least 2 SIRS criteria and one or more sepsis-induced organ failures within the 24 hours prior to inclusion, plus a SAPS II score between 35-63

Exclusion Criteria

• Patients were excluded if pregnant, younger than 18 years, in a moribund state, in chronic renal failure, or receiving immunosuppressive therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary end-point was the number, severity and duration of organ failures at 14 days, as evaluated by the SOFA score, on an intention-to-treat analysis

Secondary Outcome Measures

Name	Time	Method
Secondary end point : safety, ventilation and hemodynamic support weaning

Trial Locations

Locations (1)

Lariboisiere University Hospital; 🇫🇷 Paris, France