Control Trial of Intermittent Hemodialysis With Regional Citrate VS Priming Heparin With Predilution in Patients at Risk of Bleeding

Study Overview
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Brief Summary
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The study investigators hypothesize that intermittent hemodialysis with regional citrate anticoagulation (Prometheus system/Frésénius) is more efficient than reduced systemic heparin anticoagulation in patients at bleeding risk hospitalized in nephrology intensive care unit

Official Title
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Randomized Controlled Trial of Intermittent Hemodialysis With Regional Citrate Anticoagulation Versus Systemic Low Dose Heparin Anticoagulation in Patients at Risk of Bleeding in Nephrology Intensive Care Unit

Conditions
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Hemodialysis

Intervention / Treatment
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* Procedure: reduced systemic heparin anticoagulation
* Procedure: Regional Citrate Anticoagulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has been correctly informed. The patient must have given his/her informed and signed consent. The legal guardian or trusted-person of an adult under guardianship must have given their informed and signed consent. The patient has health insurance coverage via the French social security system. The patient is at least 18 years old. The patient is at bleeding risk; the bleeding risk is defined by the clinical situation and according to predefined clinical situations (before or after surgery or biopsy, hemorrhage). The patient requires an intermittent hemodialysis in a nephrology ICU setting. Exclusion Criteria: The patient is participating in, or has participated in over the past three months, another interventional trial. The patient is in an exclusion period determined by a previous study. The patient is under judicial protection. The parents (or legal guardian) of the patient refuse to sign the consent. It is impossible to correctly inform the patient/parents (or legal guardian) of the patient (language barrier). Contraindication to heparin treatment. Indication of continuous dialysis in ICU. Pregnancy.

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Procedure: reduced systemic heparin anticoagulation<br>* receive intermittent hemodialysis (Frésenius 4008) with blood flow at least of (200 ml/min) with double vascular access, biocompatible membrane dialyzer, low dose non fractionated heparine (5000 UI initially) and predilution with 25 mls/min dialysate<br>|
| Experimental: Prometheus System<br> | Procedure: Regional Citrate Anticoagulation<br>* intermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of intermittent hemodialysis between groups | Minutes | End of intermittent hemodialysis session (average 4 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodialysis treatment adequacy | KT/V value | End of intermittent hemodialysis session (average 4 hours) | 
| Transmembrane pressure between groups |  | End of intermittent hemodialysis session (average 4 hours) | 
| Blood aspect in the extracorporeal treatment circuit | Clotting phenomena | End of intermittent hemodialysis session (average 4 hours) | 
| Occurrence of hemorrhage | Yes/no | Hour 12 | 
| Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose) | Yes/no | Hour 12 | 
| Occurance of unexpected complications (almost none recorded in the literature) | Yes/no | End of intermittent hemodialysis session (average 4 hours) |