NCT07061457

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 14, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

November 20, 2025

Status Verified

July 1, 2025

Enrollment Period

4 months

First QC Date

June 18, 2025

Last Update Submit

November 19, 2025

Conditions

Keywords

brachial-to-radial gradientvasoactive agentsvasopressorcritically ill

Outcome Measures

Primary Outcomes (1)

  • Frequency of significant brachial-to-radial gradient

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

    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

    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

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

  • Brachial-to-radial gradient and lactates

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

Study Arms (1)

Adult critically-ill patients receiving vasoactive agents

Adult critically-ill patients receiving vasoactive agents and undergoing invasive blood pressure monitoring in the radial artery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients admitted to the intensive care unit, requiring invasive blood pressure monitoring, and undergoing vasoactive therapy.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

5 Szpital Wojskowy z Polikliniką w Krakowie

Krakow, Poland

Location

Uniwersytecki Szpital w Opolu

Opole, Poland

Location

Uniwersyteckie Centrum Kliniczne w Warszawie

Warsaw, Poland

Location

MeSH Terms

Conditions

ShockCritical Illness

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Zbigniew Putowski, MD PhD

    Center for Intensive Care and Perioperative Medicine, Jagiellonian University Medical College, Cracow, Poland

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2025

First Posted

July 11, 2025

Study Start

April 14, 2025

Primary Completion

July 31, 2025

Study Completion

August 31, 2025

Last Updated

November 20, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations