Impact of Continuous Venovenous Haemofiltration on Organ Failure During the Early Phase of Severe Sepsis
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study 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 |
- 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 end point : safety, ventilation and hemodynamic support weaning
| Estimated Enrollment: | 400 |
| Study Start Date: | March 1997 |
| Estimated Study Completion Date: | December 1999 |
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 |
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 More Information
No publications provided
| ClinicalTrials.gov 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 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hopital Lariboisière:
|
Sepsis syndrom severe sepsis septic shock hemofiltration multiple organ failure |
Additional relevant MeSH terms:
|
Bacteremia Bacterial Infections Pneumonia, Bacterial Pneumonia Sepsis Toxemia Shock Shock, Septic Gram-Negative Bacterial Infections |
Gram-Positive Bacterial Infections Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 23, 2013