NCT01228292

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: University Hospital, Antwerp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Acute Kidney Injury
• Hemodialysis

Interventions

Type	Name	Description
DRUG	Unfractionated heparin	dose 5-10 IU/kg/hrs adaptations of infusion rate upon APTT measurements during hemodialysis
DRUG	Citrasate	Citrasate is infused as a dialysate

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-01-01
• Completion: 2013-01-01
• First posted: 2010-10-26
• Last updated: 2010-10-26

Locations

1 site across 1 country: Belgium