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

NCT07837843 | Not Yet Recruiting

• 1 other identifier: 69HCL26_0902
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critically Ill Patients; Circulatory Shock; Ventilated Patients

Keywords

ICU; Circulatory shock; Oxygen consumption; Fluid responsiveness; Capillary refill time

Outcome Measures

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

  Day 0

Study Arms (1)

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

Indirect calorimetry measurement DEVICE

Setup of an indirect calorimetry measurement

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the ICU

You may qualify if:

• 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

You may not qualify if:

• 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
• Disconnection from the ventilator anticipated before the end of the study

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Shock

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rémi Schweizer, Dr

CONTACT

0033472357093; remi.schweizer@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2026
• First Posted: September 24, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-09

Locations

FR (1)