REMIMID-ICU: Remimazolam vs Midazolam for Deep Sedation in Hemodynamically Unstable, Mechanically Ventilated Adults

ClinicalTrials.Gov PRS Field-by-Field Checklist & Results Module Templates - REMIMID-ICU

This trial evaluates whether remimazolam provides superior sedation quality compared with midazolam in adults receiving invasive mechanical ventilation with ongoing vasopressor support. The primary outcome is the percentage of time within target sedation (RASS -3 to -5) without rescue sedative during the first 48 hours after randomization. Key secondary outcomes include vasopressor exposure (NEE AUC 0-48h), time to awakening, delirium incidence, ventilator-free days, and 28-day mortality.

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