Impact of Continuous Venovenous Haemofiltration on Organ Failure During the Early Phase of Severe Sepsis - Full Text View

Sponsor:	Hopital Lariboisière
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Bacterial Infections Pneumonia Sepsis

U.S. FDA Resources

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

No publications provided

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

Keywords provided by Hopital Lariboisière:

Sepsis syndrom
severe sepsis
septic shock
hemofiltration
multiple organ failure

Additional relevant MeSH terms:

Bacterial Infections
Systemic Inflammatory Response Syndrome
Communicable Diseases
Bacteremia
Infection
Gram-Negative Bacterial Infections
Inflammation
Sepsis
Gram-Positive Bacterial Infections

Pathologic Processes
Shock
Respiratory Tract Infections
Respiratory Tract Diseases
Lung Diseases
Pneumonia, Bacterial
Shock, Septic
Pneumonia

ClinicalTrials.gov processed this record on November 27, 2009