Haemofiltration Study : IVOIRE (hIgh VOlume in Intensive Care)
IVOIRE
Impact of High-volume Veno-venous Continuous Hemofiltration in the Early Management of Septic Shock Patients With Acute Renal Failure
2 other identifiers
interventional
139
3 countries
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2005
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2005
CompletedFirst Submitted
Initial submission to the registry
October 17, 2005
CompletedFirst Posted
Study publicly available on registry
October 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedOctober 13, 2010
October 1, 2010
5 years
October 17, 2005
October 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
all-cause mortality.
28-day
Secondary Outcomes (8)
Haemodynamic parameters and volume loading
Every 12 hours during 96 hours after inclusion
Doses and duration of catecholamine infusions
Every 12 hours during 96 hours after inclusion
Organ failures
During 96 hours after inclusion
Duration of mechanical ventilation
Total during the stay in intensive care
Duration of renal replacement therapy
Total during the stay in Intensive Care Unity (ICU)
- +3 more secondary outcomes
Study Arms (2)
High Volume
EXPERIMENTALultra filtration : High volume : 70 ml/kg/h
Medium Volume
ACTIVE COMPARATORUltra filtration : conventional volume : 35 ml/kg/h
Interventions
High Volume ultra filtration (70 ml/kg/h)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- cirrhosis
- age over 80 years
- life expectancy less than 3 months or metastatic cancer
- for women : pregnancy and breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital, Bordeauxlead
- Ministry of Health, Francecollaborator
Study Sites (16)
Cliniques de l'Europe
Brussels, Belgium
Astrid Queen Military Hospital
Bruxelles (Neder Over Hembeek), Belgium
TIVOLI Hospital
La Louvière, Belgium
University Hospital
Liège, Belgium
St-Pierre Para-University Hospital
Ottignies-Louvain-la-Neuve, Belgium
Hospital
Agen, 47923, France
Clinic Bordeaux Nord
Bordeaux, 33077, France
University Hospital
Brest, 29200, France
University Hospital
Grenoble, 38600, France
Hospital R Boulin - Libourne
Libourne, 33505, France
University Hospital
Lyon, 69317, France
Aphp - Hegp
Paris, 75908, France
Service d'Anesthésie-Réanimation II, Groupe Hospitalier Sud, CHU de Bordeaux
Pessac, 33604, France
Hospital
Tourcoing, 59209, France
Hospital
Delf, Netherlands
Hospital
Heerlen, Netherlands
Related Publications (2)
Medica D, Quercia AD, Marengo M, Fanelli V, Castellano G, Fabbrini P, Migliori M, Merlotti G, Camussi G, Joannes-Boyau O, Honore PM, Cantaluppi V. High-volume hemofiltration does not protect human kidney endothelial and tubular epithelial cells from septic plasma-induced injury. Sci Rep. 2024 Aug 7;14(1):18323. doi: 10.1038/s41598-024-69202-z.
PMID: 39112634DERIVEDJoannes-Boyau O, Honore PM, Perez P, Bagshaw SM, Grand H, Canivet JL, Dewitte A, Flamens C, Pujol W, Grandoulier AS, Fleureau C, Jacobs R, Broux C, Floch H, Branchard O, Franck S, Roze H, Collin V, Boer W, Calderon J, Gauche B, Spapen HD, Janvier G, Ouattara A. High-volume versus standard-volume haemofiltration for septic shock patients with acute kidney injury (IVOIRE study): a multicentre randomized controlled trial. Intensive Care Med. 2013 Sep;39(9):1535-46. doi: 10.1007/s00134-013-2967-z. Epub 2013 Jun 6.
PMID: 23740278DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 17, 2005
First Posted
October 18, 2005
Study Start
October 1, 2005
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
October 13, 2010
Record last verified: 2010-10