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

Acute Kidney Injury Clinical Trial

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

Status Not yet recruiting

Clinical Trial Summary

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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Critical Illness
• Hemodialysis

• NCT number: NCT01228292
• Study type: Interventional
• Source: University Hospital, Antwerp
• Contact: Walter Verbrugghe, MD
• Phone: 003238214149
• Email: walter.verbrugghe@uza.be
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: January 2011
• Completion date: January 2013