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

NCT06055907 | Unknown

• 1 other identifier: SKN+JS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Thrombosis

Outcome Measures

Primary Outcomes (1)

• Anti-Xa activity

  IU anty-Xa/ml

  4 hours after third dose

Study Arms (2)

NOR+ARG

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

Diagnostic Test: Serum anti-Xa activity

NOR

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

Diagnostic Test: Serum anti-Xa activity

Interventions

Serum anti-Xa activity DIAGNOSTIC_TEST

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

NOR; NOR+ARG

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort study will be conducted on a population of 50 adult patients of both sexes treated in the Intensive Care Unit at the University Clinical Center in Gdansk, Poland.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care

Gdansk, 80-214, Poland

RECRUITING

MeSH Terms

Conditions

Critical Illness; Thrombosis

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Radosław Owczuk, MD., PhD., Prof.

  Medical University of Gdansk

  STUDY DIRECTOR

Central Study Contacts

Jan Stefaniak, MD.

CONTACT

505694054; jan.stefaniak@gumed.edu.pl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: September 28, 2023
• Study Start: May 15, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

PL (1)