Outcome after prolonged sedatio

Phase 3

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

• Registration Number: DRKS00020237
• Lead Sponsor: Sedana Medical AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-07
• Study Completion: 2020-01-12
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 301

Inclusion Criteria

IsoConDa Study plus
Ventilation for more than 96 hours

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

IsoConDa Study

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
Ventilator free days after 28 days

Secondary Outcome Measures

Name	Time	Method
• 30-day mortality<br>• readmission rate<br>• Lower SOFA Score after one week<br>• Extubation rate<br>• renal failure (creatinin >1,2) (up to day 7)<br>• liver failure (up to day 7)<br>• dialysis within 30 days<br>• Invasive ventilation time (h) <br>• ICU days<br>• Hospital-free days at 30 days