Comparison of Slow Efficiency dialysis (SLEDD) with Unfractionated Heparin versus Citrasate in Critically Ill Patients

Conditions: To compare the feasability, safety and efficacy of Sustained Slow Efficiency Dialys (SLEDD) using regional anticoagulation with Citrasate compared to systemic anticoagulation with Unfractionated Heparin (UF) in critically ill patients. Prospective, randomized, single-center clinical trial recruiting patients with Acute Kidney Injury (AKI) stage III according to the RIFLE criteria and needing renal replacement therapie.
MedDRA version: 12.1Level: LLTClassification code 10018875Term: Haemodialysis
MedDRA version: 12.1Level: LLTClassification code 10052259Term: Artificial kidney clotting during dialysis

Registration Number: EUCTR2010-021665-68-BE

Lead Sponsor: niversity Hospital Antwerp

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

? Need for hemodialysis in the ICU for at least one treatment
? No prior hemodialysis treatment in the ICU except continuous renal replacement therapy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

? Need for systemic anticoagulation with unfractionated or fractionated heparin, oral anticoagulants or intravenous anti-aggregants for other reasons
? Need for continued thrombolysis therapy within the 6 hours before inclusion
? Need for continued treatment with activated protein C (drotrecogin alfa) within the 12 hours before inclusion
? Need for continued treatment with intravenous anti-aggregants (abciximab, eptifabide) withing 12 hours before inclusion
? Liver failure (acute and acute-on-chronic)
? Confirmed or suspected Heparin Induced Thrombocytopenia (HIT)
? Heparin allergies
? Severe uncorrected hypocalcemia (ionized calcium < 0,8 mmol/l)
? Refusal of informed consent

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary endpoint : The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.;Secondary Objective: Secondary endpoints :<br>? The incidence of bleeding episodes as defined by the WHO-criteria<br>? The transfusion requirements<br>? The incidence of technique failure <br>? The incidence of metabolic derangements (metabolic alkalosis, metabolic acidosis, hypocalcemia, hypercalcemia, hypernatremia, hyponatremia)<br>? The incidence of citrate intoxication <br>? The dialysis efficiency expressed as Kt/V and URR<br>Tertiary end points :<br>? All cause mortality at day 28 and day 90 after inclusion<br>;Primary end point(s): ? The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting

Secondary Outcome Measures