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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-03-31

Study Completion Date

1999-12-31

Brief Summary

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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

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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.

Conditions

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Bacteremia Gram-Negative Bacterial Infections Gram-Positive Bacterial Infections Pneumonia, Bacterial Shock, Septic Sepsis

Keywords

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Sepsis syndrom severe sepsis septic shock hemofiltration multiple organ failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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venovenous hemofiltration

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Didier Payen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hpopital Lariboisiere

Locations

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Lariboisiere University Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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ministère recherche EA 322

Identifier Type: -

Identifier Source: secondary_id

DP 97 02 06