Status:
NOT_YET_RECRUITING
REMIMID-ICU: Remimazolam vs Midazolam for Deep Sedation in Hemodynamically Unstable, Mechanically Ventilated Adults
Lead Sponsor:
Yancheng First People's Hospital
Conditions:
Critical Illness; Mechanical Ventilation; Shock
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial evaluates whether remimazolam provides superior sedation quality compared with midazolam in adults receiving invasive mechanical ventilation with ongoing vasopressor support. The primary ou...
Eligibility Criteria
Inclusion
- Inclusion
- Age ≥18 years.
- Invasive mechanical ventilation at randomization; anticipated continuous sedation ≥24 hours.
- Hemodynamic instability requiring vasopressor support despite adequate resuscitation: NEE ≥0.10 μg/kg/min for ≥1 hour within 6 hours prior to randomization, or equivalent.
- At least one sign of hypoperfusion (e.g., lactate \>2 mmol/L, oliguria, mottled skin, or altered mentation) unless solely due to sedation.
- Exclusion
- • Known pregnancy; status epilepticus; severe hepatic failure (Child-Pugh C) or on ECMO; refractory hypoxemia requiring prone position at randomization; benzodiazepine hypersensitivity; need for continuous neuromuscular blockade \>24h at baseline; moribund not expected to survive 24h; investigator judgement.
- Sexes Eligible: All Accepts Healthy Volunteers: No Ages: 18 Years and older
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07155265
Start Date
October 1 2025
End Date
September 30 2027
Last Update
September 4 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.