Finger capillary refilling time variations to evaluate effects of fluid administration in critically ill patients
| ISRCTN | ISRCTN58464956 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN58464956 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 1617411780 |
| Sponsor | Centre Hospitalier Universitaire Brugmann |
| Funder | Investigator initiated and funded |
- 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
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
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 |
| charalampos.pierrakos@chu-brugmann.be |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Prospective observational cohort |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| 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(s) |
Measured before, during, and after intake of the fluid bolus: |
| Key secondary outcome measure(s) |
Measured before, during, and after intake of the fluid bolus: |
| Completion date | 01/09/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
Bruxells
1020
Belgium
University Campus
Patras
265 04 Rio
Greece
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
03/03/2021: Trial's existence confirmed by CHU-Brugmann Ethics Committee.
