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

NCT ID: NCT01228292

Last Updated: 2010-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-01-31

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

Conditions

Acute Kidney Injury; Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Anticoagulation

Hemodialysis is performed using standard anticoagulation using unfractionated heparin if no contra-indications for the use of heparin exist. If contra-indications for heparin exist a heparin coated hemofilter (Evodial) will be used. The use of unfractionated heparin or no heparin (with coated hemofilter) is a decision to be taken before every hemodialysis.

Group Type: ACTIVE_COMPARATOR

Unfractionated heparin

Intervention Type: DRUG

dose 5-10 IU/kg/hrs adaptations of infusion rate upon APTT measurements during hemodialysis

Citrasate

Hemodialysis is performed with Citrasate

Group Type: EXPERIMENTAL

Citrasate

Intervention Type: DRUG

Citrasate is infused as a dialysate

Interventions

Unfractionated heparin

dose 5-10 IU/kg/hrs adaptations of infusion rate upon APTT measurements during hemodialysis

Intervention Type: DRUG

Citrasate

Citrasate is infused as a dialysate

Intervention Type: DRUG

Other Intervention Names

Unfractionated Heparin, LEO laboratories Ltd, MA #PL 0043/0041R; Citrasate, Advanced Renal Technologies, MA #K000792

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Critical Care Physician

Principal Investigators

Karin Jansen-Van doorn, MD

Role: PRINCIPAL_INVESTIGATOR

Staff member Nephrology Department

Gert Verpooten, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Nephrology Department, University Hospital Antwerp, Belgium

Walter Verbrugghe, MD

Role: PRINCIPAL_INVESTIGATOR

Staff member Critical Care Department, Antwerp University Hospital, Belgium

Philippe Jorens, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

Head of Critical Care Department, Antwerp University Hospital, Belgium

Locations

Critical Care Department of the Antwerp University Hospital, Belgium

Edegem, Edegem, Belgium

Countries

Belgium

Central Contacts

Walter Verbrugghe, MD

Role: CONTACT

walter.verbrugghe@uza.be

003238214149

Philippe Jorens, PhD, MD

Role: CONTACT

philippe.jorens@uza.be

003238213639

Facility Contacts

Walter Verbrugghe, MD

Role: primary

walter.Verbrugghe@uza.be

003238214149

Philippe Jorens, PhD, MD

Role: backup

philippe.jorens@uza.be

003238213639

References

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.

Reference Type: DERIVED

PMID: 33314078 (View on PubMed)

Other Identifiers

2010-021665-68

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

10/27/179

Identifier Type: -

Identifier Source: org_study_id