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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-11

Study Completion Date

2021-05-27

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

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Detailed Description

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Conditions

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Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control

Group Type ACTIVE_COMPARATOR

reduced systemic heparin anticoagulation

Intervention Type PROCEDURE

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

Prometheus System

Group Type EXPERIMENTAL

Regional Citrate Anticoagulation

Intervention Type PROCEDURE

intermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer

Interventions

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reduced systemic heparin anticoagulation

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

Intervention Type PROCEDURE

Regional Citrate Anticoagulation

intermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No