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

September 20, 2023 updated by: Medical University of Gdansk

Anti-Xa Activity in Patients Receiving Different Vasopressors.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Gdańsk, Poland, 80-214
        • Recruiting
        • Medical University of Gdansk - Departament of Anesthesiology and Intensive Care
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anti-Xa activity
Time Frame: 4 hours after third dose
IU anty-Xa/ml
4 hours after third dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 15, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

September 20, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SKN+JS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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