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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05674084
• Other study ID #: PCN/CBN/0052/KB/242/22
• Status: Recruiting
• Start date: December 3, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2022
• Source: Medical University of Silesia
• Contact: Zbigniew Putowski, Dr
• Phone: +48 32 789 42 01
• Email: putowski.zbigniew[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: October 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Intervention

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.

Locations

Country	Name	City	State
Poland	University Clinical Center named after prof. K. Gibinski of the Medical University of Silesia in Katowice	Katowice	Silesia

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Silesia

Country where clinical trial is conducted

Poland, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

McGuire D, Gotlib A, King J. Capillary Refill Time. 2022 Apr 21. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557753/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Effect of epinephrine dose on CRT value	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
Secondary	Effect of argipressin dose on CRT value	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
Secondary	Effect of dobutamine dose on CRT value	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
Secondary	CRT value in MAP <65 mmHg	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