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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-021665-68-BE

Enrollment

250

Registered

2010-09-20

Start date

2010-10-06

Completion date

Unknown

Last updated

2024-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 12.1 Level: LLT Classification code 10018875 Term: Haemodial

Interventions

Trade Name: Citrasate Product Name: Citrasate Pharmaceutical Form: Solution for haemodialysis CAS Number: 77-92-9 Other descriptive name: CITRIC ACID Concentration unit: g/l gram(s)/litre Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026