- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03562754
Control Trial of Intermittent Hemodialysis With Regional Citrate VS Priming Heparin With Predilution in Patients at Risk of Bleeding (ROBIN)
January 15, 2021 updated by: Centre Hospitalier Universitaire de Nīmes
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nîmes, France, 30029
- CHU Nîmes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
|
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
|
Experimental: Prometheus System
|
intermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of intermittent hemodialysis between groups
Time Frame: End of intermittent hemodialysis session (average 4 hours)
|
Minutes
|
End of intermittent hemodialysis session (average 4 hours)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemodialysis treatment adequacy
Time Frame: End of intermittent hemodialysis session (average 4 hours)
|
KT/V value
|
End of intermittent hemodialysis session (average 4 hours)
|
Transmembrane pressure between groups
Time Frame: End of intermittent hemodialysis session (average 4 hours)
|
End of intermittent hemodialysis session (average 4 hours)
|
|
Blood aspect in the extracorporeal treatment circuit
Time Frame: End of intermittent hemodialysis session (average 4 hours)
|
Clotting phenomena
|
End of intermittent hemodialysis session (average 4 hours)
|
Occurrence of hemorrhage
Time Frame: Hour 12
|
Yes/no
|
Hour 12
|
Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose)
Time Frame: Hour 12
|
Yes/no
|
Hour 12
|
Occurance of unexpected complications (almost none recorded in the literature)
Time Frame: End of intermittent hemodialysis session (average 4 hours)
|
Yes/no
|
End of intermittent hemodialysis session (average 4 hours)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Olivier Moranne, MD, CHU Nîmes
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 11, 2019
Primary Completion (Actual)
November 11, 2020
Study Completion (Actual)
November 11, 2020
Study Registration Dates
First Submitted
June 8, 2018
First Submitted That Met QC Criteria
June 8, 2018
First Posted (Actual)
June 19, 2018
Study Record Updates
Last Update Posted (Actual)
January 20, 2021
Last Update Submitted That Met QC Criteria
January 15, 2021
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/NIMAO2/OM-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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