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Starting soon Observational

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

NCT07837843 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-12-01
Last updated
2026-09-24

Condition(s) studied

Critically Ill PatientsCirculatory ShockVentilated Patients

Investigational drug(s) / intervention(s)

Indirect calorimetry measurement

Indirect calorimetry measurement: Setup of an indirect calorimetry measurement

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 : * 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

Primary outcome measure(s)

  • Assessment of the ability of fluid challenge-induced changes in capillary refill time to predict fluid challenge-induced changes in oxygen consumption — Day 0
    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

Trial sites (1)

FacilityCityRegionStatus
Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon Bron France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07837843 on ClinicalTrials.gov ↗ ← All trials in France