Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.

Antwerp University Hospital (UZA)

Status and phase: Unknown; Phase 4

Conditions: Hemodialysis; Acute Kidney Injury

Treatments: Drug: Unfractionated heparin; Drug: Citrasate

Study type: Interventional

Funder types: Other

Identifiers

NCT01228292

2010-021665-68 (EudraCT Number)

10/27/179

Details and patient eligibility

About

The purpose of this study is to compare the feasibility, safety and efficacy of hemodialysis with unfractionated heparin compared to hemodialysis with Citrasate in Critically Ill Patients.

Full description

Objective : To compare the feasibility, safety and efficacy of Sustained Low Efficiency Daily Hemodialysis (SLEDD) using regional anticoagulation with Citrasate® compared to systemic anticoagulation with unfractionated heparin in critically ill patients.

Design : Prospective, randomized, single-center clinical trial Setting : mixed medical-surgical 45 bed ICU in a tertiary university hospital Patients : 250 patients with Acute Kidney Injury (AKI) stage III needing renal replacement therapy Interventions : Patients are randomized to receive SLEDD using standard dialysate and systemic anticoagulation with UF versus SLEDD using Citrasate®-dialysate with no additional UF.

Measurements and main results :

Primary end point :

• The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.

Secondary end points :

• 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

Enrollment: 250 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

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) within 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

250 participants in 2 patient groups

Standard Anticoagulation

Active Comparator group

Description:

Hemodialysis is performed using standard anticoagulation using unfractionated heparin if no contra-indications for the use of heparin exist. If contra-indications for heparin exist a heparin coated hemofilter (Evodial) will be used. The use of unfractionated heparin or no heparin (with coated hemofilter) is a decision to be taken before every hemodialysis.

Treatment:

Drug: Unfractionated heparin

Citrasate

Experimental group

Description:

Hemodialysis is performed with Citrasate

Treatment:

Drug: Citrasate