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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
dose 5-10 IU/kg/hrs adaptations of infusion rate upon APTT measurements during hemodialysis
Citrasate is infused as a dialysate
Critical Care Department of the Antwerp University Hospital, Belgium
Edegem, Edegem, Belgium
The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.
Time frame: 6 hours after starting dialysis
The incidence of technique failure defined as the number of patients who develop a contra-indication for the allocated anticoagulation regimen during the study period
Time frame: during whole wtudy
The incidence of bleeding episodes. A bleeding episode is defined according to the WHO bleeding criteria
Time frame: during the whole study period
The transfusion requirements defined as the total of units blood products administrated during the ICU stay and per dialysis treatment
Time frame: during the whole study period
The incidence of metabolic derangements during the study period
* Metabolic alkalosis (defined as a pH \> 7,5 and a bicarbonate \> 24 mmol/l) * Metabolic acidosis (defined as a pH \< 7,25 and a bicarbonate \< 18 mmol/l) * Hypocalcemia (defined as an ionized calcium \< 0,9 mmol/l) * Hypercalcemia (defined as an ionized calcium \> 1,2 mol/l) * Hypernatremia (defined as a Na+ \> 145 mmol/l) * Hyponatremia (defined a a Na+ \< 130 mmol/l) * Citrate toxicity (defined as a total calcium/ionized calcium ratio \> 2,5)
Time frame: during the whole study period
Dialysis efficiency expressed as Kt/V and URR
Time frame: 6 hours after starting dialysis
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