- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Rémi Schweizer, Dr
- Telefonnummer: 0033472357093
- E-post: remi.schweizer@chu-lyon.fr
Studiesteder
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-
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Bron, Frankrike, 69500
- Service d'Anesthésie-Réanimation, Hôpital Louis Pradel, Hospices Civils de Lyon
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Ta kontakt med:
- Rémi Schweizer, Dr
- Telefonnummer: 0033472357093
- E-post: remi.schweizer@chu-lyon.fr
-
Hovedetterforsker:
- Rémi Schweizer, Dr
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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 studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / 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 |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 69HCL26_0902
Legemiddel- og utstyrsinformasjon, studiedokumenter
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