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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00406198
• Other study ID #: DP 97 02 06
• Secondary ID: ministère recher
• Status: Completed
• Phase: Phase 4
• First received: November 30, 2006
• Last updated: December 1, 2006
• Start date: March 1997
• Est. completion date: December 1999

Study information

• Verified date: November 2006
• Source: Hopital Lariboisière
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bacteremia
• Bacterial Infections
• Gram-Negative Bacterial Infections
• Gram-Positive Bacterial Infections
• Infection
• Pneumonia, Bacterial
• Sepsis
• Shock, Septic
• Toxemia

Intervention

Procedure:
• venovenous hemofiltration

Locations

Country	Name	City	State
France	Lariboisiere University Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Hopital Lariboisière	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Secondary end point : safety, ventilation and hemodynamic support weaning