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

NCT05674084 | Unknown

• 1 other identifier: PCN/CBN/0052/KB/242/22
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Critical Illness

Keywords

capillary refill time; norepinephrine; epinephrine; argipressin; dobutamine; mean arterial pressure

Outcome Measures

Primary Outcomes (2)

• Effect of norepinephrine dose on CRT value

  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

  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 Outcomes (4)

• Effect of epinephrine dose on CRT value

  Through study completion, an average of 1 year

• Effect of argipressin dose on CRT value

  Through study completion, an average of 1 year

• Effect of dobutamine dose on CRT value

  Through study completion, an average of 1 year

• CRT value in MAP <65 mmHg

  Through study completion, an average of 1 year

Study Arms (1)

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

Interventions

Capillary refill time 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.

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• critical illness requiring vasopressor support
• invasive blood pressure monitoring

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Silesia: lead

Study Sites (1)

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

Katowice, Silesian Voivodeship, 40-752, Poland

RECRUITING

Related Publications (4)

• 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/

  PMID: 32491685 BACKGROUND

• 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.

  PMID: 30772908 BACKGROUND

• 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.

  PMID: 24635770 BACKGROUND

• 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.

  PMID: 19534818 BACKGROUND

MeSH Terms

Conditions

Critical Illness; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Officials

• Łukasz Krzych, Professor

  Medical University of Silesia

  STUDY CHAIR

Central Study Contacts

Zbigniew Putowski, Dr

CONTACT

+48 32 789 42 01; putowski.zbigniew@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 11, 2022
• First Posted: January 6, 2023
• Study Start: December 3, 2022
• Primary Completion: October 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 6, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)