The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care

Not Applicable

Completed

• Conditions: Renal Failure, Acute

• Registration Number: NCT01403220
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

The primary objective of this study is to compare the efficacity of hemodiafiltration and hemofiltration for decreasing plasma urea at 12h among intensive care patients. Secondary objectives include comparing urea clearance, filter duration, and %down-time, between the two techniques.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-26
• Study First Posted: 2011-07-27
• Study Start: 2012-04
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-26
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

Inclusion Criteria

• According to RIFLE score, patient is stage 'F'
• The patient must be insured or beneficiary of a health insurance plan
• The patient meets at least one of the following criteria:
• metabolic acidosis (pH < 7.2), excluding keto-acidosis
• plasma urea > 25 mmol/l
• hyper-hydration is not controlled by diuretics

Exclusion Criteria

• Chronic, terminal renal insufficiency with dialysis
• The patient is under judicial protection, under tutorship or curatorship
• Suspect hyperkaliemia (Kaliemia > 6.5 mmol/l with electrocardiographic effects)
• Intoxications treated via dialysis
• Pregnant, lactating, parturient women
• Medical indication for localized citrate anticoagulation
• dialysis of less than 12 h
• patient or representative refuses to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.	12 hours	Proportion of dialysis sequences for which the rate of plasma urea reduction \> 60%. Rate of plasma urea reduction = (initial urea concentration - urea concentration after 12h our dialysis)/initial urea concentration.

Secondary Outcome Measures

Name	Time	Method
Filter lifespan (hours) for the dialysis sequence under study.	12 hours.	Filter lifespan (hours) for the dialysis sequence under study.
Fluid replacement (yes/no)	24 hours	Was fluid replacement necessary during the studied dialysis sequence?
Urea clearance (ml/min) for the dialysis sequence under study	12 hours	Urea clearance (ml/min) for the dialysis sequence under study.
Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%.	24 hours	Proportion of dialysis sequences for which the rate of plasma urea reduction \> 60%. Rate of plasma urea reduction = (initial urea concentration - urea concentration after 12h our dialysis)/initial urea concentration.
The percentage down-time for the first 24 hours of dialysis	24 hours	The percentage down-time for the first 24 hours of dialysis = (number of hours where the exchange is not effective / 24 hours)\*100

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Nîmes; 🇫🇷 Nîmes Cedex 09, Gard, France