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

• ClinicalTrials.gov Identifier: NCT00241228
• Recruitment Status: Completed
• First Posted: October 18, 2005
• Last Update Posted: October 13, 2010
• Sponsor: University Hospital, Bordeaux
• Collaborator: Ministry of Health, France
• Information provided by: University Hospital, Bordeaux

Study Description

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

Detailed Description:

Background

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.

Study Design

• 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

Arms and Interventions

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)

Outcome Measures

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Belgium

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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
• ClinicalTrials.gov Identifier: NCT00241228
• Other Study ID Numbers: 9410-04; 2004-024
• First Posted: October 18, 2005
• 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; Mortality

Additional relevant MeSH terms:

Shock, Septic; Renal Insufficiency; Acute Kidney Injury; Shock; Pathologic Processes; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation