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Not yet recruitingNCT07837843CARTOFLUpdated Nov 2, 2026

Capillary Refill Time Variation to Predict Oxygen Comsumption Variation After FLuid Challenge (CARTOFL)

An observational study in Critically Ill Patients, Circulatory Shock and Ventilated Patients, sponsored by Hospices Civils de Lyon. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Hospices Civils de Lyon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study summary

Circulatory shock is characterized by tissue hypoxia. Although fluid resuscitation is an essential treatment in many forms of circulatory shock, its benefits are variable, and its administration carries a risk of potentially harmful fluid overload.

Assessment of fluid responsiveness generally relies on changes in cardiac output. However, the actual therapeutic objective is rather to improve tissue oxygen utilization, as reflected by oxygen consumption. Despite its physiological relevance, direct measurement of oxygen consumption remains complex and difficult to perform in routine clinical practice.

Capillary refill time is a simple, rapid, non-invasive, and readily available marker of peripheral perfusion. It is associated with outcomes in patients with circulatory shock, and a capillary refill time-guided therapeutic strategy may improve outcomes in patients with septic shock.

This study hypothesizes that changes in capillary refill time following fluid resuscitation may predict changes in oxygen consumption induced by fluid administration. If confirmed, capillary refill time and its changes could be incorporated into the criteria used to assess the indication for fluid resuscitation in patients with shock. They would also provide additional physiological information regarding the relationship between peripheral perfusion and oxygen consumption.

02

Conditions studied

  • Critically Ill Patients
  • Circulatory Shock
  • Ventilated Patients

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Keywords

  • ICU
  • Circulatory shock
  • Oxygen consumption
  • Fluid responsiveness
  • Capillary refill time
03

In context

Shock

487 studies on the registry are indexed under Shock; 107 are open to participants now.

This study's planned enrollment of 80 is below the median of 100 across 247 observational studies indexed under Shock.

Browse Shock studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted to the ICU

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patient admitted to the intensive care unit within the previous 72 hours
  • Receiving invasive mechanical ventilation
  • For whom the clinician plans to perform a fluid challenge
  • No objection from the participant or a relative/legally authorized representative

Exclusion criteria

Exclusion Criteria :

  • Fraction of inspired oxygen greater than 60%
  • Administration of inhaled medications, including nitric oxide
  • Positive end-expiratory pressure greater than 15 cmH₂O
  • Excessive leaks in the ventilator circuit, defined as an expired volume less than 95% of the inspired volume
  • Patient receiving mechanical circulatory support involving a gas exchanger
  • Patient receiving renal replacement therapy
  • Administration of sodium bicarbonate within the 2 hours preceding inclusion
  • Disconnection from the ventilator anticipated before the end of the study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients

    The patients targeted by this study are mechanically ventilated intensive care patients for whom the attending clinician plans to perform a fluid challenge.

    Device: Indirect calorimetry measurement

Interventions

  • DeviceIndirect calorimetry measurement

    Setup of an indirect calorimetry measurement

06

What researchers measure

Primary outcomes

  1. Assessment of the ability of fluid challenge-induced changes in capillary refill time to predict fluid challenge-induced changes in oxygen consumption

    Area under the receiver operating characteristic curve of changes in capillary refill time for predicting a 15% increase in oxygen consumption during a fluid challenge

    Time frame: Day 0

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.

Of 120 non-industry observational studies under Shock, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 52. This study's planned 12 months is below that.

Counting every sponsor, half of 127 studies reached it within 26 months; a quarter within 12 and three quarters within 52.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2026
First posted
Sep 24, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Dec 1, 2027
CompletionEst.
Dec 1, 2027
Last update
Nov 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: oversight details
1 update, last Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Minor edits only
    + 1 other change: oversight details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07837843
Responsible party
Sponsor
First posted
Sep 24, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Dec 1, 2027 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Nov 2, 2026

Study contacts

Rémi Schweizer, Dr
Contact
remi.schweizer@chu-lyon.fr
0033472357093

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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