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

This study has been completed.

Sponsors and Collaborators: Hopital Lariboisière
Ministry of Health, France
Information provided by: Hopital Lariboisière
ClinicalTrials.gov Identifier: NCT00406198
  Purpose

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 Intervention Phase
Bacteremia
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Pneumonia, Bacterial
Shock, Septic
Sepsis
Procedure: venovenous hemofiltration
Phase IV

MedlinePlus related topics:   Bacterial Infections    Pneumonia    Sepsis   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:   Phase 4 Randomized Multicentric Controlled Study on Impact of Continuous Venovenous Hemofiltration on Organ Failure at the Early Phase of Severe Sepsis

Further study details as provided by Hopital Lariboisière:

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

Estimated Enrollment:   400
Study Start Date:   March 1997
Estimated Study Completion Date:   December 1999

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00406198

Locations
France
Lariboisiere University Hospital    
      Paris, France

Sponsors and Collaborators
Hopital Lariboisière
Ministry of Health, France

Investigators
Principal Investigator:     Didier Payen, MD, PhD     Hpopital Lariboisiere    
  More Information

Study ID Numbers:   DP 97 02 06, ministère recherche EA 322
First Received:   November 30, 2006
Last Updated:   December 1, 2006
ClinicalTrials.gov Identifier:   NCT00406198
Health Authority:   France: Afssaps - French Health Products Safety Agency

Keywords provided by Hopital Lariboisière:
Sepsis syndrom  
severe sepsis  
septic shock  
hemofiltration  
multiple organ failure  

Study placed in the following topic categories:
Bacterial Infections
Systemic Inflammatory Response Syndrome
Bacteremia
Gram-Negative Bacterial Infections
Inflammation
Sepsis
Gram-Positive Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Shock
Pneumonia, Bacterial
Multiple Organ Failure
Lung Diseases
Shock, Septic
Pneumonia

Additional relevant MeSH terms:
Communicable Diseases
Pathologic Processes
Infection

ClinicalTrials.gov processed this record on August 29, 2008




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