Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-29 @ 9:25 PM
Study NCT ID:
NCT07061457
Status:
COMPLETED
Last Update Posted:
2025-11-20
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Brachial-radial Pressure Gradient Phenomenon in Critically Ill Patients Treated With Vasoactive Agents
Sponsor:
Jagiellonian University
Organization:
Study Overview
Official Title:
Brachial-radial Pressure Gradient Phenomenon in Critically Ill Patients Treated With Vasoactive Agents: an Observational Study
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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. 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?
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?
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: