Not Yet RecruitingPhase 4ACTRN12606000285550

The pharmacodynamics of unfractionated heparin and fondaparinux in critically ill patients with severe sepsis.

Sponsor

Dr M Robertson

Enrollment

15 participants

Start Date

Jul 1, 2006

Study Type

Interventional

Conditions

Critically ill patients with severe sepsis.

Summary

Given the significant incidence of deep venous thromboses (DVT) in critically ill patients and the failure of current prophylactic regimens to fully prevent DVT, additional pharmacokinetic information regarding the efficacy of heparin and fondaparinux in critically ill patients is required. We aim to assess the bioavailability of heparin administered subcutaneously and intravenously and fondaparinux administered subcutaneously in a cohort of critically ill patients with severe sepsis.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates the pharmacodynamics of unfractionated heparin and fondaparinux in critically ill patients with severe sepsis. It is looking for both men and women, aged 18 and older who have 1. core temperature ³38oC or £36oC 2. heart rate ³90 beats/min unless known medical condition associated with increased heart rate or on medication.... If you are interested, you may need to attend study visits and follow the research team's instructions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

This is a pharmacokinetic study to assess the bioavailability of heparin and fondaparinux (blood thinning agents) in Intensive care Unit (ICU) patients with sepsis. The bioavailability of these blood

This is a pharmacokinetic study to assess the bioavailability of heparin and fondaparinux (blood thinning agents) in Intensive care Unit (ICU) patients with sepsis. The bioavailability of these blood thinning agents will be measured by blood tests of the factor Xa inhibition during the 72 hour study period. Patients will be randomised to receive the three anticoagulant (blood thinning) regimens sequentially and have repeated tests of the inhibition of factor Xa activity. The three heparin regimes to be assessed are: 1. Heparin 5000 Units administered subcutaneously twice daily. 2. Heparin 10 000 Units intravenously over 24 hours. 3. Fondaparinux 2.5 mg subcutaneously once daily.

Locations(1)

Australia

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ACTRN12606000285550