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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01228292
• Other study ID #: 10/27/179
• Secondary ID: 2010-021665-68
• Status: Not yet recruiting
• Phase: Phase 4
• First received: October 25, 2010
• Last updated: October 25, 2010
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: September 2010
• Source: University Hospital, Antwerp
• Contact: Walter Verbrugghe, MD
• Phone: 003238214149
• Email: walter.verbrugghe[@]uza.be
• Is FDA regulated: No
• Health authority: Belgium : Belgium, FAGG (Federaal Agentschap voor Geneesmiddelen en Gezondheidsprodukten)Europe : EudraCT
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: January 2013
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Intervention

Drug:
• Unfractionated heparin
dose 5-10 IU/kg/hrs adaptations of infusion rate upon APTT measurements during hemodialysis
• Citrasate
Citrasate is infused as a dialysate

Locations

Country	Name	City	State
Belgium	Critical Care Department of the Antwerp University Hospital, Belgium	Edegem

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.		6 hours after starting dialysis	No
Secondary	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		during whole wtudy	No
Secondary	The incidence of bleeding episodes. A bleeding episode is defined according to the WHO bleeding criteria		during the whole study period	Yes
Secondary	The transfusion requirements defined as the total of units blood products administrated during the ICU stay and per dialysis treatment		during the whole study period	Yes
Secondary	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)	during the whole study period	Yes
Secondary	Dialysis efficiency expressed as Kt/V and URR		6 hours after starting dialysis	No