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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis; Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections; Shock, Septic; Bacteremia; Pneumonia, Bacterial
• Intervention / Treatment: Procedure: venovenous hemofiltration

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 Type: Interventional
• Enrollment: 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Lariboisiere University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Secondary end point : safety, ventilation and hemodynamic support weaning

Collaborators and Investigators

• Sponsor: Hopital Lariboisière
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Didier Payen, MD, PhD, Hpopital Lariboisiere

Study record dates

Study Major Dates

• Study Start: March 1, 1997
• Study Completion: December 1, 1999

Study Registration Dates

• First Submitted: November 30, 2006
• First Submitted That Met QC Criteria: December 1, 2006
• First Posted (Estimate): December 4, 2006

Study Record Updates

• Last Update Posted (Estimate): December 4, 2006
• Last Update Submitted That Met QC Criteria: December 1, 2006
• Last Verified: November 1, 2006

More Information

Terms related to this study

• Keywords: septic shock; severe sepsis; hemofiltration; multiple organ failure; Sepsis syndrom
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Bacterial Infections and Mycoses; Shock; Sepsis; Toxemia; Infections; Communicable Diseases; Shock, Septic; Bacteremia; Pneumonia, Bacterial; Bacterial Infections; Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections
• Other Study ID Numbers: DP 97 02 06; ministère recherche EA 322