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Completed

NCT Number: NCT07061457

Brachial-radial Pressure Gradient Phenomenon in Critically Ill Patients Treated With Vasoactive Agents

The goal of this observational study is to observe brachial-to-radial pressure gradient in critically-ill patients receiving vasoactive agents. The main questions it aims to answer are:

1. What is the frequency of brachial-to-radial gradient in critically-ill patients receiving vasoactive agents? 2. Is brachial-to-radial gradient greater in patients receiving high doses of vasoactive agents? 3. Is brachial-to-radial gradient associated with worse peripheral perfusion?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

5 Szpital Wojskowy z Polikliniką w Krakowie, Krakow, Poland

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About this study

Pathological conditions, such as arterial stenosis, use of vasoconstrictive drugs, or massive vasodilatation, can cause significant differences in mean arterial pressure (MAP) in different parts of the arterial system. For example, in the case of stenosis between the brachial and radial arteries, the pressure behind the stenosis is lower than in front of it, which can lead to erroneous conclusions about the actual arterial pressure. The use of vasoconstrictive drugs in patients with circulatory insufficiency can result in reduced peripheral arterial pressure transmission, as evidenced by studies showing lower pressures in the radial artery compared to the femoral artery. Inadequate MAP assessments can lead to excessive use of vasoactive drugs and fluids, increasing the risk of complications such as cardiac ischemia, atrial fibrillation, and renal failure. One method to detect a significant gradient between central MAP (e.g., aorta or femoral artery) and peripheral MAP is non-invasive, oscillometric measurement of MAP on the brachial artery and comparing it to MAP obtained from invasive radial access (known as NIBR-APG). The brachial-radial MAP gradient is highly correlated with the femoral-radial gradient and may be indicative of significantly higher central pressure. The aim of this project is to evaluate the frequency of the brachial-radial gradient phenomenon in patients undergoing vasoconstrictive treatment in intensive care units.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult (>18 years) patients admitted to the ICU
  • must be after initial resuscitation
  • invasive blood pressure monitoring in the radial artery
  • need for vasoactive drug therapy

Exclusion criteria

  • pregnancy
  • pressure transduction across invasive blood pressure circuit deemed to be inadequate
  • mechanical circulatory support
  • inability to match non-invasive cuff size to the patient's arm
  • need for any hemodynamic intervention during performing study's measurements
  • patient's decline to have the measurements done

Treatment and study plan

Primary outcomes

  1. Frequency of significant brachial-to-radial gradient

    Time frame: At baseline (after initial resuscitation). The gradient will be assessed only once, in a cross-sectional manner.

    Frequency of significant brachial-to-radial gradient > 11 mmHg MAP

Secondary outcomes

  1. Determinants of the brachial-to-radial gradient

    Time frame: At baseline (after initial resuscitation). The variables will be collected only once in a cross-sectional manner.

    Odds ratio (OR) of norepinephrine equivalent dose and OR of other potential risk factors (diabetes, age and body surface area) for significant brachial-radial gradient (>11 mmHg MAP)

  2. Brachial-to-radial gradient and capillary refill time

    Time frame: At baseline (after initial resuscitation). Variables will be collected only once in a cross-sectional manner.

    Correlation between brachial-to-radial gradient and capillary refill time

  3. Brachial-to-radial gradient and lactates

    Time frame: At baseline (after initial resuscitation). Variables will be collected only once in a cross-sectional manner.

    Correlation between brachial-to-radial gradient and lactate concentration

Sponsors and collaborators

Lead sponsor

Jagiellonian University

Other

Registry information

Official study title

Brachial-radial Pressure Gradient Phenomenon in Critically Ill Patients Treated With Vasoactive Agents: an Observational Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 11, 2025
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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