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

Sponsor

Hopital Lariboisière (Other)

Overall Status

Completed

CT.gov ID

NCT00406198

Collaborator

Ministry of Health, France (Other)

400

Enrollment

Location

Duration (Months)

12.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bacteremia Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Pneumonia, Bacterial Shock, Septic Sepsis	Procedure: venovenous hemofiltration	Phase 4

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Phase 4 Randomized Multicentric Controlled Study on Impact of Continuous Venovenous Hemofiltration on Organ Failure at the Early Phase of Severe Sepsis

Study Start Date :

Mar 1, 1997

Study Completion Date :

Dec 1, 1999

Outcome Measures

Primary Outcome Measures

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

Secondary end point : safety, ventilation and hemodynamic support weaning []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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