Clinical trial NCT03562754: Control Trial of Intermittent Hemodialysis With Regional Citrate VS Priming Heparin With Predilution in Patients at Risk of Bleeding
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
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Duration of intermittent hemodialysis between groups
timeFrame: End of intermittent hemodialysis session (average 4 hours)
Secondary outcomes:
measure: Hemodialysis treatment adequacy
timeFrame: End of intermittent hemodialysis session (average 4 hours)
measure: Transmembrane pressure between groups
timeFrame: End of intermittent hemodialysis session (average 4 hours)
measure: Blood aspect in the extracorporeal treatment circuit
timeFrame: End of intermittent hemodialysis session (average 4 hours)
measure: Occurrence of hemorrhage
timeFrame: Hour 12
measure: Occurrence of metabolic disorders (hypocalcemia, metabolic alkalose)
timeFrame: Hour 12
measure: Occurance of unexpected complications (almost none recorded in the literature)
timeFrame: End of intermittent hemodialysis session (average 4 hours)
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Olivier Moranne, MD
role: PRINCIPAL_INVESTIGATOR
References: