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CompletedNCT00406198Updated Dec 4, 2006

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

A Phase 4 interventional study of venovenous hemofiltration in Bacteremia, Gram-Negative Bacterial Infections and Gram-Positive Bacterial Infections, sponsored by Hopital Lariboisière. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2006-12-04.

Sponsored by Hopital Lariboisière · Phase 4, Interventional, and Supportive care

Phase
Phase 4
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's enrollment of 400 is above the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

Hopital Lariboisière is the lead sponsor of 29 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • Patients were excluded if pregnant, younger than 18 years, in a moribund state, in chronic renal failure, or receiving immunosuppressive therapy.
05

Study design

Phase
Phase 4
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
400 participants

Interventions

  • Procedurevenovenous hemofiltration
06

What researchers measure

Primary outcomes

  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 outcomes

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

07

Study locations

1 site
  • Lariboisiere University Hospital
    Paris, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00406198
Lead sponsor
Hopital Lariboisière
Collaborators
Ministry of Health, France
First posted
Dec 4, 2006
Start date
Mar 1997
Completion
Dec 1999
Last update
Dec 4, 2006

Study contacts

Didier Payen, MD, PhD
principal investigator · Hpopital Lariboisiere
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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