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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by University Hospital, Antwerp.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01228292
First received: October 25, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Acute Kidney Injury
Hemodialysis
Drug: Unfractionated heparin
Drug: Citrasate
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Slow Efficiency Daily Dialysis (SLEDD) With Unfractionated Heparin Versus Citrasate in Critically Ill Patients.

Resource links provided by NLM:


Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • The incidence of premature interruptions of the dialysis procedure attributed to hemofilter clotting. [ Time Frame: 6 hours after starting dialysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • The incidence of bleeding episodes. A bleeding episode is defined according to the WHO bleeding criteria [ Time Frame: during the whole study period ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • The incidence of metabolic derangements during the study period [ Time Frame: during the whole study period ] [ Designated as safety issue: Yes ]
    • 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)

  • Dialysis efficiency expressed as Kt/V and URR [ Time Frame: 6 hours after starting dialysis ] [ Designated as safety issue: No ]

Estimated Enrollment: 250
Study Start Date: January 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Drug: Unfractionated heparin
dose 5-10 IU/kg/hrs adaptations of infusion rate upon APTT measurements during hemodialysis
Other Name: Unfractionated Heparin, LEO laboratories Ltd, MA #PL 0043/0041R
Experimental: Citrasate
Hemodialysis is performed with Citrasate
Drug: Citrasate
Citrasate is infused as a dialysate
Other Name: Citrasate, Advanced Renal Technologies, MA #K000792

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228292

Contacts
Contact: Walter Verbrugghe, MD 003238214149 walter.verbrugghe@uza.be
Contact: Philippe Jorens, PhD, MD 003238213639 philippe.jorens@uza.be

Locations
Belgium
Critical Care Department of the Antwerp University Hospital, Belgium Not yet recruiting
Edegem, Belgium, 2650
Contact: Walter Verbrugghe, MD    003238214149    walter.Verbrugghe@uza.be   
Contact: Philippe Jorens, PhD, MD    003238213639    philippe.jorens@uza.be   
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
Principal Investigator: 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
  More Information

No publications provided

Responsible Party: Walter Verbrugghe, Critical Care Physician
ClinicalTrials.gov Identifier: NCT01228292     History of Changes
Other Study ID Numbers: 10/27/179, 2010-021665-68
Study First Received: October 25, 2010
Last Updated: October 25, 2010
Health Authority: Belgium : Belgium, FAGG (Federaal Agentschap voor Geneesmiddelen en Gezondheidsprodukten)
Europe : EudraCT

Keywords provided by University Hospital, Antwerp:
Anticoagulation
Intensive Care Medicine
Hemodialysis
Critical Ill Patients

Additional relevant MeSH terms:
Critical Illness
Acute Kidney Injury
Wounds and Injuries
Disease Attributes
Pathologic Processes
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 17, 2014