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

NCT01228292 | Unknown Phase 4 DMC

• 2 other identifiers: 10/27/1792010-021665-68
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Kidney Injury; Hemodialysis

Keywords

Anticoagulation; Intensive Care Medicine; Hemodialysis; Critical Ill Patients

Outcome Measures

Primary Outcomes (1)

• The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting.

  6 hours after starting dialysis

Secondary Outcomes (5)

• 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

• The incidence of bleeding episodes. A bleeding episode is defined according to the WHO bleeding criteria

  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

  during the whole study period

• The incidence of metabolic derangements during the study period

  during the whole study period

• Dialysis efficiency expressed as Kt/V and URR

  6 hours after starting dialysis

Study Arms (2)

Standard Anticoagulation

ACTIVE COMPARATOR

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.

Drug: Unfractionated heparin

Citrasate

EXPERIMENTAL

Hemodialysis is performed with Citrasate

Drug: Citrasate

Interventions

Unfractionated heparin DRUG

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

Also known as: Unfractionated Heparin, LEO laboratories Ltd, MA #PL 0043/0041R

Standard Anticoagulation

Citrasate DRUG

Citrasate is infused as a dialysate

Also known as: Citrasate, Advanced Renal Technologies, MA #K000792

Citrasate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Need for hemodialysis in the ICU for at least one treatment
• No prior hemodialysis treatment in the ICU except continuous renal replacement therapy

You may not qualify if:

• Need for systemic anticoagulation with unfractionated or fractionated heparin, oral anticoagulants or intravenous anti-aggregants for other reasons
• 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

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Critical Care Department of the Antwerp University Hospital, Belgium

Edegem, Edegem, 2650, Belgium

Location

Related Publications (1)

• 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.

  PMID: 33314078 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Heparin

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Karin Jansen-Van doorn, MD

  Staff member Nephrology Department

  PRINCIPAL INVESTIGATOR

• Gert Verpooten, PhD, MD

  Head of Nephrology Department, University Hospital Antwerp, Belgium

  PRINCIPAL INVESTIGATOR

• Walter Verbrugghe, MD

  Staff member Critical Care Department, Antwerp University Hospital, Belgium

  PRINCIPAL INVESTIGATOR

• Philippe Jorens, PhD, MD

  Head of Critical Care Department, Antwerp University Hospital, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Walter Verbrugghe, MD

CONTACT

003238214149; walter.verbrugghe@uza.be

Philippe Jorens, PhD, MD

CONTACT

003238213639; philippe.jorens@uza.be

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 25, 2010
• First Posted: October 26, 2010
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2013
• Last Updated: October 26, 2010

Record last verified: 2010-09

Locations

BE (1)