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

This study has been completed.
Ministry of Health, France
Information provided by:
Hopital Lariboisière Identifier:
First received: November 30, 2006
Last updated: December 1, 2006
Last verified: November 2006
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
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Pneumonia, Bacterial
Shock, Septic
Procedure: venovenous hemofiltration
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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.

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.
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Please refer to this study by its identifier: NCT00406198

Lariboisiere University Hospital
Paris, France
Sponsors and Collaborators
Hopital Lariboisière
Ministry of Health, France
Principal Investigator: Didier Payen, MD, PhD Hpopital Lariboisiere
  More Information Identifier: NCT00406198     History of Changes
Other Study ID Numbers: DP 97 02 06
ministère recherche EA 322
Study First Received: November 30, 2006
Last Updated: December 1, 2006

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

Additional relevant MeSH terms:
Bacterial Infections
Gram-Negative Bacterial Infections
Gram-Positive Bacterial Infections
Communicable Diseases
Shock, Septic
Pneumonia, Bacterial
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Systemic Inflammatory Response Syndrome
Pathologic Processes
Shock processed this record on May 23, 2017