Clinical trial NCT01228292: Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.
Official title: Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Acute Kidney Injury
Hemodialysis
Keywords: Anticoagulation
Intensive Care Medicine
Hemodialysis
Critical Ill Patients
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2010-10-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility 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

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

Primary outcomes:
measure: The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.
timeFrame: 6 hours after starting dialysis
Secondary outcomes:
measure: 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
timeFrame: during whole wtudy
measure: The incidence of bleeding episodes. A bleeding episode is defined according to the WHO bleeding criteria
timeFrame: during the whole study period
measure: The transfusion requirements defined as the total of units blood products administrated during the ICU stay and per dialysis treatment
timeFrame: during the whole study period
measure: The incidence of metabolic derangements during the study period
timeFrame: during the whole study period
measure: Dialysis efficiency expressed as Kt/V and URR
timeFrame: 6 hours after starting dialysis
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Critical Care Department of the Antwerp University Hospital, Belgium
Study officials:
affiliation: Staff member Nephrology Department
name: Karin Jansen-Van doorn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Nephrology Department, University Hospital Antwerp, Belgium
name: Gert Verpooten, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Staff member Critical Care Department, Antwerp University Hospital, Belgium
name: Walter Verbrugghe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Head of Critical Care Department, Antwerp University Hospital, Belgium
name: Philippe Jorens, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tsujimoto H, Tsujimoto Y, Nakata Y, Fujii T, Takahashi S, Akazawa M, Kataoka Y. Pharmacological interventions for preventing clotting of extracorporeal circuits during continuous renal replacement therapy. Cochrane Database Syst Rev. 2020 Dec 14;12(12):CD012467. doi: 10.1002/14651858.CD012467.pub3.