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NCT06055907 Clinical Trial

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

Critical Illness Clinical Trial

Official title:
Anti-Xa Activity in Patients Receiving Different Vasopressors.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06055907
Other study ID # SKN+JS
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 15, 2023
Est. completion date September 2024

Study information
Verified date September 2023
Source Medical University of Gdansk
Contact Jan Stefaniak, MD.
Phone 505694054
Email jan.stefaniak@gumed.edu.pl
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 50
Est. completion date September 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Circulatory failure - Supported by continuous infusion of noradrenaline or noradrenaline and argipressin - Receiving subcutaneous dalteparin for the prevention of venous thromboembolism. 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Serum anti-Xa activity
4 hours after third dose of dalteparin, serum anti-Xa activity is measured

Locations
Country Name City State
Poland Medical University of Gdansk - Departament of Anesthesiology and Intensive Care Gdansk

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anti-Xa activity IU anty-Xa/ml 4 hours after third dose
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