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

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacity of Hemodiafiltration Versus Hemofiltration for Renal Insufficiency During Intensive Care: a Randomized, Open, Cross-over Study

Conditions
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Renal Failure, Acute

Intervention / Treatment
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* Procedure: Hemodiafiltration first
* Procedure: Hemofiltration first


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (hemodiafiltration first)<br>This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration. | Procedure: Hemodiafiltration first<br>* Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.<br>|
| Active Comparator: Group 2 (hemofiltration first)<br>This group of patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration. | Procedure: Hemofiltration first<br>* Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of dialysis sequences for which the rate of plasma urea reduction > 60%. | 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. | 12 hours | 

Secondary Outcome Measures

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