Circulatory FailureNCT07061457
Brachial-radial Pressure Gradient Phenomenon in Critically Ill Patients Treated With Vasoactive Agents
An observational study of Circulatory Failure and Shock, run by Jagiellonian University at 3 sites in Poland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Circulatory Failure, Shock, Vasopressor Agents
- How many people
- 300 participants
- Where
- 3 sitesPoland
- Study dates
- 14 Apr 2025to 31 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the intensive care unit, requiring invasive blood pressure monitoring, and undergoing vasoactive therapy.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Poland3 sites
5 Szpital Wojskowy z Polikliniką w Krakowie
Krakow
Uniwersytecki Szpital w Opolu
Opole
Uniwersyteckie Centrum Kliniczne w Warszawie
Warsaw
About this study
Official title: Brachial-radial Pressure Gradient Phenomenon in Critically Ill Patients Treated With Vasoactive Agents: an Observational Study
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:
- What is the frequency of brachial-to-radial gradient in critically-ill patients receiving vasoactive agents?
- Is brachial-to-radial gradient greater in patients receiving high doses of vasoactive agents?
- Is brachial-to-radial gradient associated with worse peripheral perfusion?
Read the detailed description
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.
- Conditions
- Circulatory Failure, Shock, Vasopressor Agents, Blood Pressure
- Keywords
- brachial-to-radial gradient, vasoactive agents, vasopressor, critically ill
- Medical subject headings
- Shock, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult critically-ill patients receiving vasoactive agents | Adult critically-ill patients receiving vasoactive agents and undergoing invasive blood pressure monitoring in the radial artery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of significant brachial-to-radial gradient
Frequency of significant brachial-to-radial gradient > 11 mmHg MAP
Measured: At baseline (after initial resuscitation). The gradient will be assessed only once, in a cross-sectional manner.
Secondary outcomes (3)
Determinants of the brachial-to-radial gradient
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)
Measured: At baseline (after initial resuscitation). The variables will be collected only once in a cross-sectional manner.
Brachial-to-radial gradient and capillary refill time
Correlation between brachial-to-radial gradient and capillary refill time
Measured: At baseline (after initial resuscitation). Variables will be collected only once in a cross-sectional manner.
Brachial-to-radial gradient and lactates
Correlation between brachial-to-radial gradient and lactate concentration
Measured: At baseline (after initial resuscitation). Variables will be collected only once in a cross-sectional manner.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start14 Apr 2025
- Primary completion31 Jul 2025
- Study completion31 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circulatory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wojciech Szczeklik, Jagiellonian University
- Investigators
- Zbigniew Putowski, MD PhD, Study chair, Center for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Cracow, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061457
- Sponsor's protocol ID
- 118.0043.1.305.2024
- Status last verified
- Jul 2025
- First submitted
- 18 Jun 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brachial-radial Pressure Gradient Phenomenon in Critically Ill Patients Treated With Vasoactive Agents: an Observational Study
- ClinicalTrials.gov ID
- NCT07061457
- Acronym / sponsor ID
- 118.0043.1.305.2024
- Conditions
- Circulatory Failure, Shock, Vasopressor Agents, Blood Pressure
- Keywords
- brachial-to-radial gradient, vasoactive agents, vasopressor, critically ill
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 31 Aug 2025 (actual)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What is the frequency of brachial-to-radial gradient in critically-ill patients receiving vasoactive agents?
- Is brachial-to-radial gradient greater in patients receiving high doses of vasoactive agents?
- Is brachial-to-radial gradient associated with worse peripheral perfusion?
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult critically-ill patients receiving vasoactive agents | – | –Adult critically-ill patients receiving vasoactive agents and undergoing invasive blood pressure monitoring in the radial artery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the intensive care unit, requiring invasive blood pressure monitoring, and undergoing vasoactive therapy.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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.
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.
Brachial-to-radial gradient and lactates
Time frame: At baseline (after initial resuscitation). Variables will be collected only once in a cross-sectional manner.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zbigniew Putowski, MD PhD study chair
Center for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Cracow, Poland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Circulatory Failure and Shock, run by Jagiellonian University at 3 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.