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

NCT ID: NCT05674084

Last Updated: 2023-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-03

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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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)

Conditions

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Critical Illness

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Capillary refill time

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Silesia

OTHER

Sponsor Role lead

Responsible Party

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Łukasz Krzych

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Łukasz Krzych, Professor

Role: STUDY_CHAIR

Medical University of Silesia

Locations

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University Clinical Center named after prof. K. Gibiński of the Medical University of Silesia in Katowice

Katowice, Silesian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Zbigniew Putowski, Dr

Role: CONTACT

+48 32 789 42 01

Facility Contacts

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Zbigniew Putowski, Dr

Role: primary

+48 32 789 42 01

References

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McGuire D, Gotlib A, King J. Capillary Refill Time. 2023 Apr 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557753/

Reference Type BACKGROUND
PMID: 32491685 (View on PubMed)

Hernandez G, Ospina-Tascon GA, Damiani LP, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Granda-Luna V, Cavalcanti AB, Bakker J; The ANDROMEDA SHOCK Investigators and the Latin America Intensive Care Network (LIVEN); Hernandez G, Ospina-Tascon G, Petri Damiani L, Estenssoro E, Dubin A, Hurtado J, Friedman G, Castro R, Alegria L, Teboul JL, Cecconi M, Cecconi M, Ferri G, Jibaja M, Pairumani R, Fernandez P, Barahona D, Cavalcanti AB, Bakker J, Hernandez G, Alegria L, Ferri G, Rodriguez N, Holger P, Soto N, Pozo M, Bakker J, Cook D, Vincent JL, Rhodes A, Kavanagh BP, Dellinger P, Rietdijk W, Carpio D, Pavez N, Henriquez E, Bravo S, Valenzuela ED, Vera M, Dreyse J, Oviedo V, Cid MA, Larroulet M, Petruska E, Sarabia C, Gallardo D, Sanchez JE, Gonzalez H, Arancibia JM, Munoz A, Ramirez G, Aravena F, Aquevedo A, Zambrano F, Bozinovic M, Valle F, Ramirez M, Rossel V, Munoz P, Ceballos C, Esveile C, Carmona C, Candia E, Mendoza D, Sanchez A, Ponce D, Ponce D, Lastra J, Nahuelpan B, Fasce F, Luengo C, Medel N, Cortes C, Campassi L, Rubatto P, Horna N, Furche M, Pendino JC, Bettini L, Lovesio C, Gonzalez MC, Rodruguez J, Canales H, Caminos F, Galletti C, Minoldo E, Aramburu MJ, Olmos D, Nin N, Tenzi J, Quiroga C, Lacuesta P, Gaudin A, Pais R, Silvestre A, Olivera G, Rieppi G, Berrutti D, Ochoa M, Cobos P, Vintimilla F, Ramirez V, Tobar M, Garcia F, Picoita F, Remache N, Granda V, Paredes F, Barzallo E, Garces P, Guerrero F, Salazar S, Torres G, Tana C, Calahorrano J, Solis F, Torres P, Herrera L, Ornes A, Perez V, Delgado G, Lopez A, Espinosa E, Moreira J, Salcedo B, Villacres I, Suing J, Lopez M, Gomez L, Toctaquiza G, Cadena Zapata M, Orazabal MA, Pardo Espejo R, Jimenez J, Calderon A, Paredes G, Barberan JL, Moya T, Atehortua H, Sabogal R, Ortiz G, Lara A, Sanchez F, Hernan Portilla A, Davila H, Mora JA, Calderon LE, Alvarez I, Escobar E, Bejarano A, Bustamante LA, Aldana JL. Effect of a Resuscitation Strategy Targeting Peripheral Perfusion Status vs Serum Lactate Levels on 28-Day Mortality Among Patients With Septic Shock: The ANDROMEDA-SHOCK Randomized Clinical Trial. JAMA. 2019 Feb 19;321(7):654-664. doi: 10.1001/jama.2019.0071.

Reference Type BACKGROUND
PMID: 30772908 (View on PubMed)

Asfar P, Meziani F, Hamel JF, Grelon F, Megarbane B, Anguel N, Mira JP, Dequin PF, Gergaud S, Weiss N, Legay F, Le Tulzo Y, Conrad M, Robert R, Gonzalez F, Guitton C, Tamion F, Tonnelier JM, Guezennec P, Van Der Linden T, Vieillard-Baron A, Mariotte E, Pradel G, Lesieur O, Ricard JD, Herve F, du Cheyron D, Guerin C, Mercat A, Teboul JL, Radermacher P; SEPSISPAM Investigators. High versus low blood-pressure target in patients with septic shock. N Engl J Med. 2014 Apr 24;370(17):1583-93. doi: 10.1056/NEJMoa1312173. Epub 2014 Mar 18.

Reference Type BACKGROUND
PMID: 24635770 (View on PubMed)

Dubin A, Pozo MO, Casabella CA, Palizas F Jr, Murias G, Moseinco MC, Kanoore Edul VS, Palizas F, Estenssoro E, Ince C. Increasing arterial blood pressure with norepinephrine does not improve microcirculatory blood flow: a prospective study. Crit Care. 2009;13(3):R92. doi: 10.1186/cc7922. Epub 2009 Jun 17.

Reference Type BACKGROUND
PMID: 19534818 (View on PubMed)

Other Identifiers

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PCN/CBN/0052/KB/242/22

Identifier Type: -

Identifier Source: org_study_id

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