Critical IllnessNCT05674084
Vasopressor Support, Mean Arterial Pressure and Capillary Refill Time in Critically Ill Patients
An observational study of Critical Illness, run by Medical University of Silesia at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Capillary refill time
- How many people
- 150 participants
- Where
- 1 sitePoland
- Study dates
- 3 Dec 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- critical illness requiring vasopressor support
- invasive blood pressure monitoring
Who cannot join
- finger distal phalanx not available
- patient in a room of suboptimal ambient temperature
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
University Clinical Center named after prof. K. Gibiński of the Medical University of Silesia in Katowice
Katowice, Silesian Voivodeship, 40-752
Zbigniew Putowski, Dr, +48 32 789 42 01, putowski.zbigniew@gmail.com
About this study
Official title: 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.
Read the 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)
- Conditions
- Critical Illness
- Being tested
- Capillary refill time
- Keywords
- capillary refill time, norepinephrine, epinephrine, argipressin, dobutamine, mean arterial pressure
- Medical subject headings
- Critical Illness, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capillary refill timeDiagnostic 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 | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Capillary refill time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of norepinephrine dose on CRT value
In a multiple linear regression, it will be verified whether different doses of norepinephrine determine CRT value.
Measured: 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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (4)
Effect of epinephrine dose on CRT value
In a multiple linear regression, it will be verified whether different doses of epinephrine determine CRT value.
Measured: Through study completion, an average of 1 year
Effect of argipressin dose on CRT value
In a multiple linear regression, it will be verified whether different doses of argipressin determine CRT value.
Measured: Through study completion, an average of 1 year
Effect of dobutamine dose on CRT value
In a multiple linear regression, it will be verified whether different doses of dobutamine determine CRT value.
Measured: Through study completion, an average of 1 year
CRT value in MAP <65 mmHg
It will be analyzed whether in hypotensive conditions (MAP <65 mmHg), CRT values are normal (< 3 sec)
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start3 Dec 2022
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Łukasz Krzych, Medical University of Silesia
- Investigators
- Łukasz Krzych, Professor, Study chair, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05674084
- Sponsor's protocol ID
- PCN/CBN/0052/KB/242/22
- Status last verified
- Dec 2022
- First submitted
- 11 Dec 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McGuire D, Gotlib A, King J. Capillary Refill Time. 2023 Apr 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557753/
PubMed 32491685Hernandez 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.
PubMed 30772908Asfar 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.
PubMed 24635770Dubin 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.
PubMed 19534818
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Vasopressor Support and Mean Arterial Pressure on Capillary Refill Time Values in Critically Ill Patients: Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT05674084
- Acronym / sponsor ID
- PCN/CBN/0052/KB/242/22
- Conditions
- Critical Illness
- Keywords
- capillary refill time, norepinephrine, epinephrine, argipressin, dobutamine, mean arterial pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 3 Dec 2022 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 6 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Diagnostic Test: Capillary refill timeCritically 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- critical illness requiring vasopressor support
- invasive blood pressure monitoring
Key exclusion criteria (2 listed)
- finger distal phalanx not available
- patient in a room of suboptimal ambient temperature
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capillary refill timeCRT 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. | Diagnostic test | Study group |
Primary outcome
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.
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.
4 secondary outcomes
Effect of epinephrine dose on CRT value
Time frame: 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
Effect of dobutamine dose on CRT value
Time frame: Through study completion, an average of 1 year
CRT value in MAP <65 mmHg
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Background: PubMed 32491685McGuire D, Gotlib A, King J. Capillary Refill Time. 2023 Apr 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK557753/
- Background: PubMed 30772908Hernandez 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.
- Background: PubMed 24635770Asfar 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.
- Background: PubMed 19534818Dubin 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.
- Individual participant dataSharing planned: No
Related trials for Critical Illness
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Active, not recruiting
Weighted Blankets for Agitation in Adults in the Intensive Care Unit
Psychomotor Agitation, Critical Illness
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
RecruitingObservational study
Predicting Extubation Failure Using Machine Learning
Extubation Failure, Critical Illness
Not yet recruiting
ICU-SUCCEED for Survivors of Acute Respiratory Failure and Their Caregivers
Acute Respiratory Failure, Critical Illness
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Łukasz Krzych, Professor study chair
Medical University of Silesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zbigniew Putowski, Dr (+48 32 789 42 01, putowski.zbigniew@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of norepinephrine dose on CRT value (time frame: Through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05674084, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2023.