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

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ClinicalTrials.gov Identifier: NCT00406198
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : December 4, 2006
Ministry of Health, France
Information provided by:
Hopital Lariboisière

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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 : March 1997
Estimated Study Completion Date : December 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. Secondary end point : safety, ventilation and hemodynamic support weaning

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406198

Lariboisiere University Hospital
Paris, France
Sponsors and Collaborators
Hopital Lariboisière
Ministry of Health, France
Principal Investigator: Didier Payen, MD, PhD Hpopital Lariboisiere

ClinicalTrials.gov Identifier: NCT00406198     History of Changes
Other Study ID Numbers: DP 97 02 06
ministère recherche EA 322
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: December 4, 2006
Last Verified: November 2006

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

Additional relevant MeSH terms:
Communicable Diseases
Bacterial Infections
Shock, Septic
Pneumonia, Bacterial
Gram-Positive Bacterial Infections
Gram-Negative Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes