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Argatroban Versus Lepirudin in Critically Ill Patients

NCT00798525 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2012-06-21

No results posted yet for this study

Summary

The purpose of this study is to test the hypotheses that argatroban significantly increases efficacy and safety of renal replacement therapy measured as life time of haemodialysis filters as compared to lepirudin

Conditions

  • Heparin Induced Thrombocytopenia (HIT)

Interventions

DRUG

Argatroban

Argatra (Argatroban) will be diluted to 0.6 mg/ml and 0.5 µg/kg/min will be administered continuously in patients without liver disfunction. In patients with liver disfunction, defined by a bilirubin of \> 4mg/dl, argatroban will be administered as a continuous infusion of 0,25 µg/kg/min with a final concentration of 0,3 mg/ml.

DRUG

Lepirudin

Refludan (Lepirudin) will be diluted to a final concentration of 0.1mg/ml and initiated as a continuous infusion of 5µg/kg/h in patients with continuous renal replacement therapy. In patients with moderate renal impairment (Creatinine ≥1,3 mg/dl) a final concentration 0,2 mg/ml of will be used to provide continuous infusion of 10 µg/kg/h. Patients without renal impairment (Creatinine \< 1,3 mg/dl) will receive a continuous infusion of 50 µg/kg/h by a final concentration of 1 mg/ml of Lepirudin.

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Peter Kienbaum, MD · Uniklinik Düsseldorf, Klinik für Anästhesiologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00798525 on ClinicalTrials.gov