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

Sponsor

Medical University of Gdansk (Other)

Overall Status

Recruiting

CT.gov ID

NCT06055907

Collaborator

(none)

Enrollment

Location

15.6

Anticipated Duration (Months)

3.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Critical Illness Thrombosis	Diagnostic Test: Serum anti-Xa activity

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Anti-Xa Activity in Patients Receiving Different Vasopressors.

Actual Study Start Date :

May 15, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
NOR+ARG Critically ill patients receiving norepinephrine and argipressin, with antithrombotic prophylaxis with 5000 IU of dalteparin.	Diagnostic Test: Serum anti-Xa activity 4 hours after third dose of dalteparin, serum anti-Xa activity is measured
NOR Critically ill patients receiving norepinephrine alone, with antithrombotic prophylaxis with 5000 IU of dalteparin.	Diagnostic Test: Serum anti-Xa activity 4 hours after third dose of dalteparin, serum anti-Xa activity is measured

Arm

Intervention/Treatment

NOR+ARG

Critically ill patients receiving norepinephrine and argipressin, with antithrombotic prophylaxis with 5000 IU of dalteparin.

Diagnostic Test: Serum anti-Xa activity

4 hours after third dose of dalteparin, serum anti-Xa activity is measured

NOR

Critically ill patients receiving norepinephrine alone, with antithrombotic prophylaxis with 5000 IU of dalteparin.

Diagnostic Test: Serum anti-Xa activity

4 hours after third dose of dalteparin, serum anti-Xa activity is measured

Outcome Measures

Primary Outcome Measures

Anti-Xa activity [4 hours after third dose]
IU anty-Xa/ml

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care	Gdańsk		Poland	80-214

Sponsors and Collaborators

Medical University of Gdansk

Investigators

Study Director: Radosław Owczuk, MD., PhD., Prof., Medical University of Gdansk

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Gdansk

ClinicalTrials.gov Identifier:

NCT06055907

Other Study ID Numbers:

SKN+JS

First Posted:

Sep 28, 2023

Last Update Posted:

Sep 28, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thrombosis

Critical Illness

Heparin, Low-Molecular-Weight

Dalteparin

Study Results

No Results Posted as of Sep 28, 2023