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Haemofiltration Study : IVOIRE (hIgh VOlume in Intensive Care) (IVOIRE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00241228
Recruitment Status : Completed
First Posted : October 18, 2005
Last Update Posted : October 13, 2010
Ministry of Health, France
Information provided by:
University Hospital, Bordeaux

Brief Summary:
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 or disease Intervention/treatment Phase
Shock, Septic Renal Failure, Acute Device: Venovenous haemofiltration (renal replacement therapy) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : October 2005
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. all-cause mortality. [ Time Frame: 28-day ]

Secondary Outcome Measures :
  1. Haemodynamic parameters and volume loading [ Time Frame: Every 12 hours during 96 hours after inclusion ]
  2. Doses and duration of catecholamine infusions [ Time Frame: Every 12 hours during 96 hours after inclusion ]
  3. Organ failures [ Time Frame: During 96 hours after inclusion ]
  4. Duration of mechanical ventilation [ Time Frame: Total during the stay in intensive care ]
  5. Duration of renal replacement therapy [ Time Frame: Total during the stay in Intensive Care Unity (ICU) ]
  6. Morbidity [ Time Frame: Total during the stay in intensive care ]
  7. Length of stay in ICU and hospital [ Time Frame: End of hospitalization ]
  8. Mortality [ Time Frame: in ICU (96 first hours after inclusion), 60 and 90-day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00241228

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Astrid Queen Military Hospital
Bruxelles (Neder Over Hembeek), Belgium
Cliniques de l'Europe
Bruxelles, Belgium
TIVOLI Hospital
La Louviere, Belgium
University Hospital
Liege, Belgium
St-Pierre Para-University Hospital
Ottignies-Louvain-La-Neuve, Belgium
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
Tourcoing, France, 59209
Delf, Netherlands
Heerlen, Netherlands
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry of Health, France
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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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00241228    
Other Study ID Numbers: 9410-04
First Posted: October 18, 2005    Key Record Dates
Last Update Posted: October 13, 2010
Last Verified: October 2010
Keywords provided by University Hospital, Bordeaux:
Shock, Septic
Renal Failure, Acute
Venovenous Hemofiltration
Randomized Controlled Trial
Multicenter Study
Additional relevant MeSH terms:
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Shock, Septic
Renal Insufficiency
Acute Kidney Injury
Pathologic Processes
Kidney Diseases
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Systemic Inflammatory Response Syndrome