Skip to main content
OpenTrials
Completed

NCT Number: NCT03562754

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hemodialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

reduced systemic heparin anticoagulation

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

Regional Citrate Anticoagulation

Procedure

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

Primary outcomes

  1. Duration of intermittent hemodialysis between groups

    Time frame: End of intermittent hemodialysis session (average 4 hours)

    Minutes

Secondary outcomes

  1. Hemodialysis treatment adequacy

    Time frame: End of intermittent hemodialysis session (average 4 hours)

    KT/V value

  2. Transmembrane pressure between groups

    Time frame: End of intermittent hemodialysis session (average 4 hours)

  3. Blood aspect in the extracorporeal treatment circuit

    Time frame: End of intermittent hemodialysis session (average 4 hours)

    Clotting phenomena

  4. Occurrence of hemorrhage

    Time frame: Hour 12

    Yes/no

  5. Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose)

    Time frame: Hour 12

    Yes/no

  6. Occurance of unexpected complications (almost none recorded in the literature)

    Time frame: End of intermittent hemodialysis session (average 4 hours)

    Yes/no

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: ROBIN

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2018
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.