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Completed PHASE4 INTERVENTIONAL NCT00406198

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

Phase 4 Randomized Multicentric Controlled Study on Impact of Continuous Venovenous Hemofiltration on Organ Failure at the Early Phase of Severe Sepsis

Sponsor: Hopital Lariboisière

Updated 5 times since 2017 Last updated: Dec 1, 2006 Started: Mar 31, 1997 Completion: Dec 31, 1999
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Bacteremia and Gram-Negative Bacterial Infections, this trial is completed. The trial is conducted by Hopital Lariboisière and has accumulated 5 data snapshots since 1997. Infectious disease trials contribute critical data for public health response and treatment development.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

5 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE4

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

  5. Jan 2017 — Jun 2018 [monthly]

    Completed PHASE4

    First recorded

Mar 1997

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Hopital Lariboisière
  • Ministry of Health, France
Data source: Hopital Lariboisière

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations