Finger capillary refilling time variations to evaluate effects of fluid administration in critically ill patients

ISRCTN	ISRCTN58464956
DOI	https://doi.org/10.1186/ISRCTN58464956
Secondary identifying numbers	1617411780

Submission date: 25/02/2021
Registration date: 04/03/2021
Last edited: 03/03/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
For a patient with dangerously low blood pressure, a doctor may order a “bolus” of 1 or 2 litres of IV fluids to be given rapidly to increase the patient’s blood pressure.
Fluid bolus (FB) can improve tissue perfusion (the passage of fluid to an organ or a tissue) in critically ill patients. The central venous-to-arterial carbon dioxide tension difference (PvaCO2) is a metabolic parameter that is closely related to tissue perfusion during fluid bolus. Tissue perfusion can be also evaluated with finger capillary refilling time (CRT) after firmly compressing the finger tissue. The aim of this study is to evaluate the relation between changes in PvaCO2 and CRT during fluid bolus.

Who can participate?
Adults with suspected hypovolemia (decrease in the volume of blood, which can be due to blood loss or loss of body fluids) who are being treated in the intensive care unit.

What does the study involve?
Participants will have PvaCO2 and CRT measured before and after receiving a fluid bolus.

What are the possible benefits and risks of participating?
None.

Where is the study run from?
1. Centre Hospitalier Universitaire Brugmann (Belgium)
2. General University Hospital of Patras (Greece)

When is the study starting and how long is it expected to run for?
October 2020 to September 2023

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Charalampos Pierrakos, charalampos.pierrakos@chu-brugmann.be

Contact information

Dr Charalampos Pierrakos
Scientific

Centre Hospitalier Universitaire Brugmann
Place Van Gehuchten 4 - 1020
Bruxelles
1020
Belgium

ORCID ID	0000-0003-2920-8350
Phone	+32 (0)2 477.21.11
Email	charalampos.pierrakos@chu-brugmann.be

Study information

Study design	Prospective observational cohort
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	No participant information sheet available
Scientific title	Capillary refill time for the assessment fluid bolus tissue perfusion effects in critically ill patients
Study acronym	CaRTFBas
Study objectives	1. Decreases in capillary refill time (CRT) during fluid bolus (FB) are correlated with decrease in central venous-to-arterial carbon dioxide tension difference (PvaCO2) 2.1. The combination of PvaCO2 and CRT before FB can predict decreases in PvaCO2 decreases 2.2. To evaluate changes in CRT in relation to changes in hemodynamic parameters 2.3. Relative decreases in CRT after passive leg raising can be used to identify PvaCO2 decreases after FB
Ethics approval(s)	Approved 09/02/2021, CHU-Brugmann Ethics Committee (Place Van Gehuchten 4 - 1020 Bruxelles, Belgium; +3224773916; comite.ethique@chu-brugmann.be), ref: CE2021/29
Health condition(s) or problem(s) studied	Hypovolemia (loss of blood volume) in critically ill patients
Intervention	1) Passive leg raising manoeuvre if it is possible according to the clinical situation 2) Patient’s finger will be firmly compressed for 10 sec. The whole procedure will be recorded with a smartphone’s video camera regulated to 60 frames per seconds and focused on the patient’s finger. CRT measurements will be made before after fluid bolus 3) Fluid bolus (FB): 4ml/kg of crystalloids fluids will be given within 20 minutes 4) Central venous blood gas analysis before and after FB 5) Cardiac echocardiography before and after FB
Intervention type	Other
Primary outcome measure	Measured before, during, and after intake of the fluid bolus: 1. Capillary refilling time measured using a chronometer 2. PvaCO2 measured using blood gas analysis with using blood gas analysis devices (RAPID Point 500®; Siemens Health-care Limited, Germany)
Secondary outcome measures	Measured before, during, and after intake of the fluid bolus: 1. Cardiac index measured with transthoracic echocardiography 2. Mean arterial pressure measured using sphygmomanometer
Overall study start date	01/10/2020
Completion date	01/09/2023

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	100
Key inclusion criteria	1. Central venous line present in internal jugular vein and arterial line 2. PvaCO2 >6mmHg
Key exclusion criteria	1. Age <18 years 2. Extracorporeal membrane oxygenation (ECMO) support 3. Interventions within 15 minutes before FB: increase inotrope dosage, introduction of mechanical ventilation 4. Arterial or venous PCO2 >75mmHg before or after FB 5. FB for acute bleeding 6. Admission to ICU or hemodynamic instability for less than 6 hours 7. Interventions (i.e. changes in ventilator parameters, change in the dose of inotropes) within 1h before FB 8. Severe peripheric vasoconstriction or hypothermia: not possible to evaluate peripheral saturation with pulse oximetry
Date of first enrolment	01/03/2021
Date of final enrolment	01/03/2023

Locations

Countries of recruitment

Belgium
Greece

Study participating centres

Centre Hospitalier Universitaire Brugmann

Place Van Gehuchten 4
Bruxells
1020
Belgium

General University Hospital of Patras

University of Patras
University Campus
Patras
265 04 Rio
Greece

Sponsor information

Centre Hospitalier Universitaire Brugmann
Hospital/treatment centre

Place Van Gehuchten 4 - 1020
Bruxelles
1020
Belgium

Phone	+32 (0)2 477.21.11
Email	comite.ethique@chu-brugmann.be
Website	https://www.chu-brugmann.be
"ROR"	https://ror.org/011apjk30

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	01/06/2023
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The current data sharing plans for this study are unknown and will be available at a later date.

Editorial Notes

03/03/2021: Trial's existence confirmed by CHU-Brugmann Ethics Committee.