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

Not Applicable

Completed

• Conditions: Hemodialysis
• Interventions: Procedure: reduced systemic heparin anticoagulation; Procedure: Regional Citrate Anticoagulation

• Registration Number: NCT03562754
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-06-08
• Study First Submitted QC: 2018-06-08
• Study First Posted: 2018-06-19
• Study Start: 2019-03-11
• Status Verified: 2020-11
• Primary Completion: 2020-11-11
• Study Completion: 2020-11-11
• Last Update Submitted: 2021-01-15
• Last Update Posted: 2021-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	reduced systemic heparin anticoagulation	-
Prometheus System	Regional Citrate Anticoagulation	-

Primary Outcome Measures

Name	Time	Method
Duration of intermittent hemodialysis between groups	End of intermittent hemodialysis session (average 4 hours)	Minutes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France