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

Hemodialysis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03562754
• Other study ID #: 2016/NIMAO2/OM-01
• Status: Completed
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: November 11, 2020

Study information

• Verified date: November 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 11, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis
• Hemorrhage

Intervention

Procedure:
• 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
• Regional Citrate Anticoagulation
intermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of intermittent hemodialysis between groups	Minutes	End of intermittent hemodialysis session (average 4 hours)
Secondary	Hemodialysis treatment adequacy	KT/V value	End of intermittent hemodialysis session (average 4 hours)
Secondary	Transmembrane pressure between groups		End of intermittent hemodialysis session (average 4 hours)
Secondary	Blood aspect in the extracorporeal treatment circuit	Clotting phenomena	End of intermittent hemodialysis session (average 4 hours)
Secondary	Occurrence of hemorrhage	Yes/no	Hour 12
Secondary	Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose)	Yes/no	Hour 12
Secondary	Occurance of unexpected complications (almost none recorded in the literature)	Yes/no	End of intermittent hemodialysis session (average 4 hours)