Impact of Continuous Venovenous Haemofiltration on Organ Failure During the Early Phase of Severe Sepsis
Primary Purpose
Bacteremia, Gram-Negative Bacterial Infections, Gram-Positive Bacterial Infections
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
venovenous hemofiltration
Sponsored by
About this trial
This is an interventional supportive care trial for Bacteremia focused on measuring Sepsis syndrom, severe sepsis, septic shock, hemofiltration, multiple organ failure
Eligibility 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.
Sites / Locations
- Lariboisiere University Hospital
Outcomes
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
Full Information
NCT ID
NCT00406198
First Posted
November 30, 2006
Last Updated
December 1, 2006
Sponsor
Hopital Lariboisière
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT00406198
Brief Title
Impact of Continuous Venovenous Haemofiltration on Organ Failure During the Early Phase of Severe Sepsis
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 Type
Interventional
2. Study Status
Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
March 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Hopital Lariboisière
Collaborators
Ministry of Health, France
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacteremia, Gram-Negative Bacterial Infections, Gram-Positive Bacterial Infections, Pneumonia, Bacterial, Shock, Septic, Sepsis
Keywords
Sepsis syndrom, severe sepsis, septic shock, hemofiltration, multiple organ failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
venovenous hemofiltration
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Secondary end point : safety, ventilation and hemodynamic support weaning
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Didier Payen, MD, PhD
Organizational Affiliation
Hpopital Lariboisiere
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lariboisiere University Hospital
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
Impact of Continuous Venovenous Haemofiltration on Organ Failure During the Early Phase of Severe Sepsis
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