Vasopressor Support, Mean Arterial Pressure and Capillary Refill Time in Critically Ill Patients

December 21, 2022 updated by: Łukasz Krzych, Medical University of Silesia

Influence of Vasopressor Support and Mean Arterial Pressure on Capillary Refill Time Values in Critically Ill Patients: Prospective, Observational Study

The goal of this observational study is to learn whether different doses of various vasopressor drugs influence capillary refill time (CRT) value in crtically ill patients. The main questions it aims to answer are:

  • How do vasopressor drugs determine CRT value
  • How does mean arterial pressure (MAP) determine CRT value
  • How often CRT value is normal (< 3 sec) despite hypotensive MAP (<65 mmHg)

Participants will have the CRT measured over the course of the ICU hospitalization. At the end of the study, multiple linear regression will be performed to verify whether different doses of vasopressor drugs influence CRT value.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this observational study is to learn whether different doses of various vasopressor drugs influence capillary refill time (CRT) value in critically ill patients. The main questions it aims to answer are:

  • How does norepinephrine dose influence CRT value
  • How does epinephrine dose influence CRT value
  • How does argipressin dose influence CRT value
  • How does dobutamine dose influence CRT value
  • How does mean arterial pressure (MAP) determine CRT value
  • How often CRT value is normal (< 3 sec) despite hypotensive MAP (<65 mmHg)

Participants will have the CRT measured over the course of the ICU hospitalization. At the end of the study, multiple linear regression will be performed to verify whether different doses of vasopressor drugs influence CRT value. CRT will be a dependent variable. Independent variables will be as follows: age, MAP, norepinephrine dose, epinephrine dose, argipressin dose, dobutamine dose.

CRT measurements will be performed in a standarized rigor (light, chronometer, pressure and ambient temperature will be the same in all patients)

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Silesia
      • Katowice, Silesia, Poland, 40-752
        • Recruiting
        • University Clinical Center named after prof. K. Gibiński of the Medical University of Silesia in Katowice
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult critically ill patients requiring vasopressor support will be included in the study. Over the course of the ICU hospitalization, a maximal number of 5 CRT measurements will be made.

Description

Inclusion Criteria:

  • critical illness requiring vasopressor support
  • invasive blood pressure monitoring

Exclusion Criteria:

  • finger distal phalanx not available
  • patient in a room of suboptimal ambient temperature

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study group
Critically ill patients undergoing any vasopressor treatment. CRT will be measured over the course of hospitalization. Maximal number of CRT measurements from a single patient is limited to 5.
Diagnostic test: Capillary refill time
CRT will be measured by applying firm pressure to the ventral surface of the index finger distal phalanx with a glass microscope slide. The pressure will be increased until the skin is blank and then maintained for 10 seconds. The time for return of the normal skin color will be registered with a chronometer, and > 3 seconds is defined as abnormal. Light and ambient temperature will be the same for all individuals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of norepinephrine dose on CRT value
Time Frame: Through study completion, an average of 1 year
In a multiple linear regression, it will be verified whether different doses of norepinephrine determine CRT value.
Through study completion, an average of 1 year
Effect of mean arterial pressure on CRT value
Time Frame: Through study completion, an average of 1 year
In a multiple linear regression, it will be verified whether different values of MAP determine CRT value.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of epinephrine dose on CRT value
Time Frame: Through study completion, an average of 1 year
In a multiple linear regression, it will be verified whether different doses of epinephrine determine CRT value.
Through study completion, an average of 1 year
Effect of argipressin dose on CRT value
Time Frame: Through study completion, an average of 1 year
In a multiple linear regression, it will be verified whether different doses of argipressin determine CRT value.
Through study completion, an average of 1 year
Effect of dobutamine dose on CRT value
Time Frame: Through study completion, an average of 1 year
In a multiple linear regression, it will be verified whether different doses of dobutamine determine CRT value.
Through study completion, an average of 1 year
CRT value in MAP <65 mmHg
Time Frame: Through study completion, an average of 1 year
It will be analyzed whether in hypotensive conditions (MAP <65 mmHg), CRT values are normal (< 3 sec)
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Investigators

  • Study Chair: Łukasz Krzych, Professor, Medical University of Silesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2022

Primary Completion (Anticipated)

October 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

December 11, 2022

First Submitted That Met QC Criteria

December 21, 2022

First Posted (Estimate)

January 6, 2023

Study Record Updates

Last Update Posted (Estimate)

January 6, 2023

Last Update Submitted That Met QC Criteria

December 21, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PCN/CBN/0052/KB/242/22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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