Hemodialysis
Conditions
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
Interventions
PROCEDUREreduced 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
PROCEDURERegional Citrate Anticoagulation
intermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of intermittent hemodialysis between groups | End of intermittent hemodialysis session (average 4 hours) | Minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transmembrane pressure between groups | End of intermittent hemodialysis session (average 4 hours) | — |
| Blood aspect in the extracorporeal treatment circuit | End of intermittent hemodialysis session (average 4 hours) | Clotting phenomena |
| Hemodialysis treatment adequacy | End of intermittent hemodialysis session (average 4 hours) | KT/V value |
| 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 |
| Occurrence of hemorrhage | Hour 12 | Yes/no |
Countries
France
Outcome results
None listed