Haemofiltration Study : IVOIRE (hIgh VOlume in Intensive Care)
NCT ID: NCT00241228
Last Updated: 2010-10-13
Study Results
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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COMPLETED
NA
139 participants
INTERVENTIONAL
2005-10-31
2010-10-31
Brief Summary
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Detailed Description
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Sepsis and septic shock are still important causes of mortality in intensive care medicine nowadays. Mortality ranges from 40 up to 80 % depending on the number of organ failures. Therapeutic strategy consists of two major components: haemodynamic stabilization with restoration of adequate arterial pressure and optimization of peripheral perfusion delivery, and infection treatment. Mortality remains high despite the use of new antimicrobial therapy and adjuvant therapies such as activated protein C, low dose corticoids and haemofiltration. Initial observations in patients with acute renal failure treated by haemofiltration showed azotemia control, restoration of the sodium-water balance, elimination of inflammatory mediators and improvement of the cardiac and pulmonary functions was demonstrated independently of a negative water balance. There is no human randomized study so far demonstrating these preliminary findings. Nevertheless, several authors have demonstrated inflammatory mediators elimination by the use of haemofiltration. Moreover, the clinical improvement seems to be related to the ultra filtration dose and to the early initiation of therapy. Joannes-Boyau et al carried out a pilot study in abdominal surgery patients demonstrating that the use of high volume haemofiltration in patients with septic shock and multiple organ failure restores hemodynamic stability with drastic reductions in catecholamine requirements and a substantial reduction of observed vs. expected mortality.
Objectives
The principal objective of the study is to evaluate the effect of early Continuous High Volume Haemofiltration on 28-day mortality in patients with septic shock complicated by acute renal failure. The secondary objectives are to assess the effect of High Volume Haemofiltration on haemodynamics, doses of catecholamines, organ failures, duration of mechanical ventilation, duration of renal replacement therapy need, morbidity, length of ICU and hospital stay, and 60- and 90-day mortality.
Study design
Open label randomized multicenter controlled trial on two parallel groups of patients with septic shock and acute renal failure admitted to ICU, treated early either by high volume (70 ml/kg/h) or by standard volume (35 ml/kg/h) haemofiltration.
Eligibility criteria
Inclusion criteria. Septic shock (Bone criteria) for less than 24 hours, RIFLE criteria : injury or worse, age over 18 years, and written informed consent by next of kin. Non inclusion criteria. Cirrhosis, age over 80 years, life expectancy less than 3 months or metastatic cancer.
Intervention
High volume (70 ml/kg/h) vs. standard volume (35 ml/kg/h) haemofiltration during 96 hours. Further renal replacement therapy (if haemofiltration, only standard volume is allowed) may be used according to investigator decision.
Primary endpoint
All cause 28-day mortality.
Statistical aspects
460 patients are planned to be included (230 in each group). A 15 % absolute reduction in 28-days all-cause mortality in the high volume group compared with the standard group is expected. However, as this reduction might be greater, an interim analysis is planned when half of the total sample size will have been included. Data will be analyzed on an intention-to-treat basis.
Duration of the study: 3 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High Volume
ultra filtration : High volume : 70 ml/kg/h
Venovenous haemofiltration (renal replacement therapy)
High Volume ultra filtration (70 ml/kg/h)
Medium Volume
Ultra filtration : conventional volume : 35 ml/kg/h
Venovenous haemofiltration (renal replacement therapy)
Conventional Volume (35 ml/kg/h)
Interventions
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Venovenous haemofiltration (renal replacement therapy)
High Volume ultra filtration (70 ml/kg/h)
Venovenous haemofiltration (renal replacement therapy)
Conventional Volume (35 ml/kg/h)
Eligibility Criteria
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Inclusion Criteria
* RIFLE criteria : injury or worse
* age over 18 years
* written informed consent by next of kin.
Exclusion Criteria
* age over 80 years
* life expectancy less than 3 months or metastatic cancer
* for women : pregnancy and breastfeeding
18 Years
80 Years
ALL
No
Sponsors
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Ministry of Health, France
OTHER_GOV
University Hospital, Bordeaux
OTHER
Responsible Party
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University Hospital, Bordeaux
Principal Investigators
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Olivier JOANNES-BOYAU, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux, France
Patrick HONORE, Dr
Role: PRINCIPAL_INVESTIGATOR
Quuen Astrid Military Hospital, BRUXELLES - Belgium
Paul Perez, Dr
Role: STUDY_CHAIR
University Hospital, Bordeaux, France
Locations
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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, , France
Clinic Bordeaux Nord
Bordeaux, , France
University Hospital
Brest, , France
University Hospital
Grenoble, , France
Hospital R Boulin - Libourne
Libourne, , France
University Hospital
Lyon, , France
Aphp - Hegp
Paris, , France
Service d'Anesthésie-Réanimation II, Groupe Hospitalier Sud, CHU de Bordeaux
Pessac, , France
Hospital
Tourcoing, , France
Hospital
Delf, , Netherlands
Hospital
Heerlen, , Netherlands
Countries
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References
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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.
Joannes-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.
Other Identifiers
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2004-024
Identifier Type: -
Identifier Source: secondary_id
9410-04
Identifier Type: -
Identifier Source: org_study_id