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

NCT ID: NCT06055907

Last Updated: 2023-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-15

Study Completion Date

2024-09-30

Brief Summary

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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

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Conditions

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Critical Illness Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NOR+ARG

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

Serum anti-Xa activity

Intervention Type DIAGNOSTIC_TEST

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.

Serum anti-Xa activity

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Serum anti-Xa activity

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Gdansk

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Radosław Owczuk, MD., PhD., Prof.

Role: STUDY_DIRECTOR

Medical University of Gdansk

Locations

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Medical University of Gdańsk - Departament of Anesthesiology and Intensive Care

Gdansk, , Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Jan Stefaniak, MD.

Role: CONTACT

505694054 ext. 0048

Facility Contacts

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Radosław Owczuk, MD, PhD

Role: primary

Other Identifiers

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SKN+JS

Identifier Type: -

Identifier Source: org_study_id

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