search
Back to results

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

Primary Purpose

Hemodialysis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
reduced systemic heparin anticoagulation
Regional Citrate Anticoagulation
Sponsored by
Centre Hospitalier Universitaire de Nīmes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU Nimes

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Prometheus System

Arm Description

Outcomes

Primary Outcome Measures

Duration of intermittent hemodialysis between groups
Minutes

Secondary Outcome Measures

Hemodialysis treatment adequacy
KT/V value
Transmembrane pressure between groups
Blood aspect in the extracorporeal treatment circuit
Clotting phenomena
Occurrence of hemorrhage
Yes/no
Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose)
Yes/no
Occurance of unexpected complications (almost none recorded in the literature)
Yes/no

Full Information

First Posted
June 8, 2018
Last Updated
January 15, 2021
Sponsor
Centre Hospitalier Universitaire de Nīmes
search

1. Study Identification

Unique Protocol Identification Number
NCT03562754
Brief Title
Control Trial of Intermittent Hemodialysis With Regional Citrate VS Priming Heparin With Predilution in Patients at Risk of Bleeding
Acronym
ROBIN
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
November 11, 2020 (Actual)
Study Completion Date
November 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Title
Prometheus System
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
reduced systemic heparin anticoagulation
Intervention Description
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
Intervention Name(s)
Regional Citrate Anticoagulation
Intervention Description
intermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer
Primary Outcome Measure Information:
Title
Duration of intermittent hemodialysis between groups
Description
Minutes
Time Frame
End of intermittent hemodialysis session (average 4 hours)
Secondary Outcome Measure Information:
Title
Hemodialysis treatment adequacy
Description
KT/V value
Time Frame
End of intermittent hemodialysis session (average 4 hours)
Title
Transmembrane pressure between groups
Time Frame
End of intermittent hemodialysis session (average 4 hours)
Title
Blood aspect in the extracorporeal treatment circuit
Description
Clotting phenomena
Time Frame
End of intermittent hemodialysis session (average 4 hours)
Title
Occurrence of hemorrhage
Description
Yes/no
Time Frame
Hour 12
Title
Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose)
Description
Yes/no
Time Frame
Hour 12
Title
Occurance of unexpected complications (almost none recorded in the literature)
Description
Yes/no
Time Frame
End of intermittent hemodialysis session (average 4 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Moranne, MD
Organizational Affiliation
CHU Nimes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs