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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00241228 |
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Date of registration:
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17/10/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Haemofiltration Study : IVOIRE (hIgh VOlume in Intensive Care)
IVOIRE |
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Scientific title:
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Impact of High-volume Veno-venous Continuous Hemofiltration in the Early Management of Septic Shock Patients With Acute Renal Failure |
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Date of first enrolment:
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October 2005 |
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Target sample size:
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139 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00241228 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Belgium
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France
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Netherlands
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Contacts
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Name:
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Paul Perez, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Bordeaux, France |
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Name:
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Patrick HONORE, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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Quuen Astrid Military Hospital, BRUXELLES - Belgium |
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Name:
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Olivier JOANNES-BOYAU, Dr |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Bordeaux, France |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Renal Failure, Acute
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Shock, Septic
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Intervention(s)
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Device: Venovenous haemofiltration (renal replacement therapy)
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Primary Outcome(s)
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all-cause mortality.
[Time Frame: 28-day]
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Secondary Outcome(s)
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Duration of renal replacement therapy
[Time Frame: Total during the stay in Intensive Care Unity (ICU)]
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Organ failures
[Time Frame: During 96 hours after inclusion]
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Duration of mechanical ventilation
[Time Frame: Total during the stay in intensive care]
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Haemodynamic parameters and volume loading
[Time Frame: Every 12 hours during 96 hours after inclusion]
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Doses and duration of catecholamine infusions
[Time Frame: Every 12 hours during 96 hours after inclusion]
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Morbidity
[Time Frame: Total during the stay in intensive care]
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Mortality
[Time Frame: in ICU (96 first hours after inclusion), 60 and 90-day]
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Length of stay in ICU and hospital
[Time Frame: End of hospitalization]
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Secondary ID(s)
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2004-024
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9410-04
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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