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NCT07099014Toborzás még nem indult3. fázis

Inhaled Isoflurane for Sedation of Invasively Ventilated Patients With Cardiogenic Shock on Extracorporeal Membrane Oxygenation

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. aug. 1. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még

Rövid összefoglaló (regiszter, angolul)

Midazolam and propofol are the most used intravenous (IV) sedative agents, but their use is associated with well-known adverse effects such as accumulation, myotoxicity, tachyphylaxis, and unpredictable wake-up time. For benzodiazepines, an increased tolerance, possible accumulation after long-term use, and an increased risk of acute withdrawal syndrome are reported. In patients on extracorporeal membrane oxygenation (ECMO) for cardiogenic shock, the negative hemodynamic effects of these drugs are a particular matter of concern. Besides the extracorporeal circuit itself may affect the pharmacokinetics of these IV sedatives. Indeed, drug sequestration in ECMO circuits is a well-known phenomenon influenced by drug chemo-physical properties. Given the large surface area of tubing and membrane, considerable quantities of drugs used in ECMO patients may be sequestered over a period, resulting in a significant increase in their volume of distribution. Similarly, frequent hemodilution and organ dysfunction would also contribute to an increase in the volume of distribution. Propofol, which is lipophilic is significantly sequestrated in the circuit. Consequently, it is commonly observed that patients receiving ECMO have substantially higher sedative and analgesic drug requirements than patients without ECMO. To date, there is no ideal concept for analgesia and sedation of patients on ECMO in the ICU. A drug that sedates effectively but with minimal residual sedation after the end of the administration and without the aforementioned drawbacks of the current agents would be valuable. Interestingly, a recent randomized controlled non-inferiority trial that randomized 338 patients showed that, compared with propofol, sedation with inhaled anaesthetics was non-inferior. Sedation with inhaled anaesthetics resulted in a higher rate of spontaneous breathing and a shorter wake-up time after 48h of sedation. Indeed, inhaled sedation, which has been associated with reduced opioid consumption and less delirium in ICU patients, is a promising alternative to IV sedation. Moreover, inhaled anaesthetics might be associated with less myocardial injury and lower doses of inotropic support in patients undergoing cardiac surgery. However, to date, the experience with volatile agents remains limited in patients on ECMO. We hypothesized that the use of inhaled isoflurane with the Sedaconda anaesthetics conserving device (ACD) in cardiogenic shock patients on ECMO will reduce the mortality and increase the number of ventilation-free days at day 28 following ECMO onset compared to usual IV sedation by propofol and/or midazolam.

Állapot (regiszter)
Toborzás még nem indult
Fázis (regiszter)
3. fázis
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
300 (tervezett)
Első benyújtás
2025. júl. 16.
Kezdés
2025. szept. 15.
Elsődleges befejezés
2028. okt. 13.
Fő szponzor
Assistance Publique - Hôpitaux de Paris
NCT-szám
NCT07099014
EU CT-szám
2023-510261-94-00

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó · 3. fázis
  • Tervezett résztvevők: 300
  • 2025. szept. 15. és az elsődleges befejezés (2028. okt. 13.) között
  • Nincs megadott helyszín, ország nélkül
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • Participation in another interventional study or being in the exclusion period at the end of a previous study.

Más betegség

  • Suspected or proven intracranial hypertension
  • Chronic liver disease defined as a Child-Pugh score of 12-15
  • Contraindication or allergies to isoflurane, propofol, midazolam or other halogenated anaesthetics

Laborértékek

  • Corrected QT interval \> 450ms or with a known or suspected genetic predisposition to malignant hyperthermia

Életkor

  • Age \<18 and \>75

Egyéb

  • Pregnancy or breastfeeding
  • Initiation of ECMO \>24 hours
  • Initiation of mechanical ventilation \>48 hours
  • Cardiopulmonary Resuscitation \>20 minutes before randomization
  • Patient moribund on the day of randomization, SAPS II \>90
  • Patients ventilated with a tidal volume \< 4ml/kg predicted body weight

Kiket keres a vizsgálat

  • Cardiogenic shock on VA ECMO support for less than 24 hours
  • Patients on invasive mechanical ventilation receiving propofol and/or midazolam at the time of randomization
  • Invasive mechanical ventilation for less than 48 hours
  • Expected invasive ventilation and sedation for at least 24h, with a prescribed Richmond agitation scale target within the range of -1 to - 4
  • Social security registration (AME excluded)

Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

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