Influence of Vasopressors on Anti-Xa Activity in Critically Ill Patients

Recruiting

• Conditions: Critical Illness; Thrombosis
• Interventions: Diagnostic Test: Serum anti-Xa activity

• Registration Number: NCT06055907
• Lead Sponsor: Medical University of Gdansk

Brief Summary

Critically ill patients require antithrombotic prophylaxis. At the same time, majority of them is receiving various vasopressors. The aim of the study is to determine whether there is a difference in anti-Xa activity, which is a marker of anti thrombotic activity of low molecular weight heparins, between the patients receiving norepinephrine with argipressin, compared to those receiving norepinephrine alone.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-15
• Status Verified: 2023-09
• Study First Submitted: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Last Update Submitted: 2023-09-20
• Study First Posted: 2023-09-28
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Circulatory failure
• Supported by continuous infusion of noradrenaline or noradrenaline and argipressin
• Receiving subcutaneous dalteparin for the prevention of venous thromboembolism.

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Exclusion Criteria

• Contraindications for dalteparin
• Severe coagulopathy
• Acute or subacute bacterial endocarditis
• Pregnant women
• BMI (body mass index) > 30kg/m2
• Chronic kidney disease with eGFR (estimated glomerular filtration rate) < 30 ml/min/1.73 m2
• Renal replacement therapy
• The patient died within 52 hours of starting VTE (venous thromboembolism) prophylaxis with dalteparin

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NOR+ARG	Serum anti-Xa activity	Critically ill patients receiving norepinephrine and argipressin, with antithrombotic prophylaxis with 5000 IU of dalteparin.
NOR	Serum anti-Xa activity	Critically ill patients receiving norepinephrine alone, with antithrombotic prophylaxis with 5000 IU of dalteparin.

Primary Outcome Measures

Name	Time	Method
Anti-Xa activity	4 hours after third dose	IU anty-Xa/ml

Trial Locations

Locations (1)

Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care; 🇵🇱 Gdańsk, Poland