Haemofiltration Study : IVOIRE (hIgh VOlume in Intensive Care)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00241228
First received: October 17, 2005
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

Sepsis and septic shock are still important causes of mortality in intensive care medicine. Renal replacement therapy by standard volume haemofiltration is currently used, but a higher-volume haemofiltration may improve the prognosis. The study is a prospective randomized multicenter trial comparing two treatments in patients suffering from septic shock complicated with acute renal failure admitted to ICU. One group will be treated by early high volume haemofiltration (70 ml/kg/h) and the second group by standard volume haemofiltration (35 ml/kg/h). The main outcome will be one-month mortality.


Condition Intervention
Shock, Septic
Renal Failure, Acute
Device: Venovenous haemofiltration (renal replacement therapy)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of High-volume Veno-venous Continuous Hemofiltration in the Early Management of Septic Shock Patients With Acute Renal Failure

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • all-cause mortality. [ Time Frame: 28-day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Haemodynamic parameters and volume loading [ Time Frame: Every 12 hours during 96 hours after inclusion ] [ Designated as safety issue: Yes ]
  • Doses and duration of catecholamine infusions [ Time Frame: Every 12 hours during 96 hours after inclusion ] [ Designated as safety issue: Yes ]
  • Organ failures [ Time Frame: During 96 hours after inclusion ] [ Designated as safety issue: No ]
  • Duration of mechanical ventilation [ Time Frame: Total during the stay in intensive care ] [ Designated as safety issue: No ]
  • Duration of renal replacement therapy [ Time Frame: Total during the stay in Intensive Care Unity (ICU) ] [ Designated as safety issue: No ]
  • Morbidity [ Time Frame: Total during the stay in intensive care ] [ Designated as safety issue: No ]
  • Length of stay in ICU and hospital [ Time Frame: End of hospitalization ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: in ICU (96 first hours after inclusion), 60 and 90-day ] [ Designated as safety issue: No ]

Enrollment: 139
Study Start Date: October 2005
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Volume
ultra filtration : High volume : 70 ml/kg/h
Device: Venovenous haemofiltration (renal replacement therapy)
High Volume ultra filtration (70 ml/kg/h)
Active Comparator: Medium Volume
Ultra filtration : conventional volume : 35 ml/kg/h
Device: Venovenous haemofiltration (renal replacement therapy)
Conventional Volume (35 ml/kg/h)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • septic shock (Bone criteria) for less than 24 hours
  • RIFLE criteria : injury or worse
  • age over 18 years
  • written informed consent by next of kin.

Exclusion Criteria:

  • cirrhosis
  • age over 80 years
  • life expectancy less than 3 months or metastatic cancer
  • for women : pregnancy and breastfeeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00241228

Locations
Belgium
Cliniques de l'Europe
Bruxelles, Belgium
Astrid Queen Military Hospital
Bruxelles (Neder Over Hembeek), Belgium
TIVOLI Hospital
La Louviere, Belgium
University Hospital
Liege, Belgium
St-Pierre Para-University Hospital
Ottignies-Louvain-La-Neuve, Belgium
France
Hospital
Agen, France, 47923
Clinic Bordeaux Nord
Bordeaux, France, 33077
University Hospital
Brest, France, 29200
University Hospital
Grenoble, France, 38600
Hospital R Boulin - Libourne
Libourne, France, 33505
University Hospital
Lyon, France, 69317
Aphp - Hegp
Paris, France, 75908
Service d'Anesthésie-Réanimation II, Groupe Hospitalier Sud, CHU de Bordeaux
Pessac, France, 33604
Hospital
Tourcoing, France, 59209
Netherlands
Hospital
Delf, Netherlands
Hospital
Heerlen, Netherlands
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
Investigators
Principal Investigator: Olivier JOANNES-BOYAU, Dr University Hospital, Bordeaux, France
Principal Investigator: Patrick HONORE, Dr Quuen Astrid Military Hospital, BRUXELLES - Belgium
Study Chair: Paul Perez, Dr University Hospital, Bordeaux, France
  More Information

No publications provided by University Hospital, Bordeaux

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00241228     History of Changes
Other Study ID Numbers: 9410-04, 2004-024
Study First Received: October 17, 2005
Last Updated: October 12, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Bordeaux:
Shock, Septic
Renal Failure, Acute
Venovenous Hemofiltration
Randomized Controlled Trial
Multicenter Study
Mortality

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Shock
Shock, Septic
Infection
Inflammation
Kidney Diseases
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014