- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07837843
Capillary Refill Time Variation to Predict Oxygen Comsumption Variation After FLuid Challenge (CARTOFL) (CARTOFL)
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.
Studieoversigt
Status
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Rémi Schweizer, Dr
- Telefonnummer: 0033472357093
- E-mail: remi.schweizer@chu-lyon.fr
Studiesteder
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Bron, Frankrig, 69500
- Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
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Kontakt:
- Rémi Schweizer, Dr
- Telefonnummer: 0033472357093
- E-mail: remi.schweizer@chu-lyon.fr
-
Ledende efterforsker:
- Rémi Schweizer, Dr
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Patients admitted to the ICU
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Patients
The patients targeted by this study are mechanically ventilated intensive care patients for whom the attending clinician plans to perform a fluid challenge. |
Setup of an indirect calorimetry measurement |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Assessment of the ability of fluid challenge-induced changes in capillary refill time to predict fluid challenge-induced changes in oxygen consumption
Tidsramme: 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 |
Day 0
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 69HCL26_0902
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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