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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
Hopital Lariboisière
ClinicalTrials.gov Identifier:
NCT00406198
First received: November 30, 2006
Last updated: December 1, 2006
Last verified: November 2006

November 30, 2006
December 1, 2006
March 1997
Not Provided
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
Same as current
Complete list of historical versions of study NCT00406198 on ClinicalTrials.gov Archive Site
Secondary end point : safety, ventilation and hemodynamic support weaning
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Bacteremia
  • Gram-Negative Bacterial Infections
  • Gram-Positive Bacterial Infections
  • Pneumonia, Bacterial
  • Shock, Septic
  • Sepsis
Procedure: venovenous hemofiltration
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
400
December 1999
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00406198
DP 97 02 06, ministère recherche EA 322
Not Provided
Not Provided
Hopital Lariboisière
Ministry of Health, France
Principal Investigator: Didier Payen, MD, PhD Hpopital Lariboisiere
Hopital Lariboisière
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP