Isoflurane vs. Propofol for sedation in mechanically ventilated patients with acute hypoxemic respiratory failure: an a priori hypothesis substudy of a randomized controlled trial

Phase 3

Recruiting

• Conditions: J80.09; J80.01; J81; J80.03; J80.02; Pulmonary oedema

• Registration Number: DRKS00018959
• Lead Sponsor: Sedana Medical AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Participation in Isoconda-Trial (A randomised, controlled, open-label study to confirm the efficacy and safety of sedation with isoflurane in invasively ventilated ICU patients using the AnaConDa administration system) plus PaO2/FiO2-ratio < 300 at baseline

Inclusion criteria for the main study called A randomised, controlled, open-label study to confirm the efficacy and safety of sedation with isoflurane in invasively ventilated ICU patients using the AnaConDa administration system:

1. Male or female subjects, = 18 years (18 or older)
2. Continuous invasive ventilation and sedation = 48 hours (48 hours or less) at start of study sedation
3. Clinically likely to need invasive ventilation and sedation = 24 hours (24 hours or more) at randomisation
4. Ongoing sedation with propofol at time of randomisation
5. Prescribed target sedation depth within the RASS range -1 to -4
6. Signed informed consent or emergency situation inclusion criteria fulfilled and documented.

Exclusion Criteria

Exclusion criteria for Isoconda-trial plus
extubation less than 36 hours after randomisation
unavailability of arterial blood gas sample at end of study sedation (48+-12 hours after randomization).

Exclusion criteria for the main study called A randomised, controlled, open-label study to confirm the efficacy and safety of sedation with isoflurane in invasively ventilated ICU patients using the AnaConDa administration system
1. Has not reached prescribed target sedation depth any time within the last 8 hours at randomisation
2. History of or genetic predisposal for malignant hyperthermia
3. Uncompensated acute circulatory failure at time of randomisation (MAP < 55 mmHg despite iv fluids and vasopressors).
4. Hepatic impairment of classification C according to the Child-Pugh score (Cholongitas et al., 2005).
5. Any for the study, relevant clinically significant abnormalities in clinical chemistry or haematology results at the time of screening, precluding study participation, as judged by the investigator
6. Acute neuropathology without ICP monitoring, including but not limited to stroke, neurosurgery and head trauma.
7. Planned anaesthesia or surgery within 24 hours from randomisation
8. Tidal volume < 350 ml
9. History of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject’s ability to participate in the study
10. Need for continuous muscle relaxation at the time of randomisation
11. Positive pregnancy test in women
12. History of allergy/hypersensitivity to isoflurane or propofol
13. Known participation in any other clinical study that included drug treatment within three months of the first administration of investigational product
14. Documented limitation of medical treatment.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in PaO2/FiO2-ratio between baseline and end of study sedation (at 48+-12 hours after randomisation).

Secondary Outcome Measures

Name	Time	Method
• 30-day mortality <br>• Ventilator-free days alive during first 30 days after randomization<br>• arterial partial pressure of carbon dioxide (PaCO2) at end of study sedation<br>• pH at end of study sedation <br>• PaO2/FiO2 – ratio (worst value within 24 hours) at day 5 of the 7-day-follow-up (corresponding to day 7 after randomization) <br>• time to extubation in 30-day-survivors (use censoring in Kaplan-Meier-Diagram)