NCT03562754

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 8, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
9 months until next milestone

Study Start

First participant enrolled

March 11, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2021

Completed
Last Updated

December 4, 2025

Status Verified

November 1, 2020

Enrollment Period

2.2 years

First QC Date

June 8, 2018

Last Update Submit

November 26, 2025

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (1)

  • Duration of intermittent hemodialysis between groups

    Minutes

    End of intermittent hemodialysis session (average 4 hours)

Secondary Outcomes (6)

  • Hemodialysis treatment adequacy

    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

    End of intermittent hemodialysis session (average 4 hours)

  • Occurrence of hemorrhage

    Hour 12

  • Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose)

    Hour 12

  • +1 more secondary outcomes

Study Arms (2)

Control

ACTIVE COMPARATOR
Procedure: reduced systemic heparin anticoagulation

Prometheus System

EXPERIMENTAL
Procedure: Regional Citrate Anticoagulation

Interventions

reduced systemic heparin anticoagulationPROCEDURE

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

Control
Regional Citrate AnticoagulationPROCEDURE

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

Prometheus System

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • The patient is participating in, or has participated in over the past three months, another interventional trial.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

  • Faguer S, Serre JE, Brusq C, Bongard V, Casemayou A, Moranne O, Pfirmann P, Rafat C, Cointault O. A randomized crossover trial of regional anticoagulation modalities for intermittent haemodialysis. Nephrol Dial Transplant. 2025 Feb 28;40(3):537-543. doi: 10.1093/ndt/gfae155.

    PMID: 38977911RESULT

Study Officials

  • Olivier Moranne, MD

    CHU Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2018

First Posted

June 19, 2018

Study Start

March 11, 2019

Primary Completion

May 27, 2021

Study Completion

May 27, 2021

Last Updated

December 4, 2025

Record last verified: 2020-11

Locations

FR(1)