Trial · NCT07880548
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 17 of 17
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to successful extubation | From randomization to 28 days after randomization | Successful extubation defined as: (a) intubated patients - spontaneous breathing within 48 h after extubation without need for mechanical ventilatory support; (b) non-invasive ventilation patients - spontaneous breathing with PEEP/CPAP ≤ 5 cmH2O within 48 h; (c) tracheostomized patients - spontaneous breathing with PEEP/CPAP ≤ 5 cmH2O within 48 h. |
| Secondary | Change from baseline to daily mean arterial pressure (MAP) | From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Change from baseline to daily mean arterial pressure (MAP) within the 7 days (or successful extubation) after randomization. Mean arterial pressure (MAP) was monitored hourly, and the daily MAP value was computed as the mean of all 24 hourly measurements. |
| Secondary | Change from baseline to daily vasoactive-inotropic score | From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Change from baseline to daily vasoactive-inotropic score within the 7 days (or successful extubation) after randomization |
| Secondary | Change from baseline to follow-up in total cholesterol and triglycerides | From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | total cholesterol and triglycerides are measured at the screening period (baseline) and every 7 days after randomization |
| Secondary | Change from baseline to daily SOFA-2 score | From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Difference between mean daily SOFA-2 score within 7 days after randomization (or successful extubation, whichever comes first) and the baseline SOFA-2 score. |
| Secondary | Time from study drug administration to first achievement of optimal sedation | From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Time from randomization to first achievement of optimal sedation (optimal sedation defined based on the SQAT) |
| Secondary | The proportion of rescue sedation | From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | The proportion of subjects receiving rescue sedation in each group during 0-24 h, 0-48 h, 0-72 h, 0-96 h, 0-120 h, or the treatment period |
| Secondary | The proportion of delirium | From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Incidence and duration of delirium druing study period (CAM-ICU was assessed every 12 h after randomization during ICU) |
| Secondary | Vasopressor-free days within 28-day after randomizaiton | From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | |
| Secondary | The length of ICU stay | From randomization to ICU discharge ( up to 28 days after randomization) | Days randomization to ICU discharge |
| Secondary | Mortality at 28 days and 90 days after randomization | From randomization to 90 days after randomization | |
| Secondary | Intensive care unit experience at 28 days and 90 days after randomization | From randomization to 90 days after randomization | ICU experience was measured using ICU experience questionnaire (ICEQ). This questionnaire comprises five dimensions and 21 items, with each item scored on a scale of 1 to 5, yielding a total score ranging from 21 to 105. Higher scores indicate a more favorable patient experience during ICU hospitalization. |
| Secondary | Health-related quality of life at 28 days and 90 days after randomization | From the screening period (baseline) to 90 days after randomization | Health-related quality of life was measured using EQ-5D-5L questionnaire at the screening period, 28 days and 90 days after randomization. The EQ-5D-5L questionnaire comprises five dimensions, each scored from 1 to 5, with higher scores indicating poorer health status. |
| Other | The proportion of sedation success | From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | The proportion of sedation success in each group during 0-24 h, 0-48 h, 0-72 h, 0-96 h, 0-120 h, or the treatment period (target sedation: -2 ≤ RASS ≤ +1, sedation success was defined as achieving the target sedation level for more than 70% of study drug administration duration without the need for rescue sedation) |
| Other | Sedation attainment rate | From randomization to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Sedation attainment rate was defined as the percentage of time with RASS -2 to +1 during study drug administration |
| Other | Inflammatory cytokines and proteomics | From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Plasma were collected at baseline, 24 h, 72 h, 7 days, and on the day of successful extubation |
| Other | PK plasma concentration | From the screening period (baseline) to 28 days after randomization, or until discharge from ICU, death, or withdrawal from the study | Plasma were collected at baseline, 24 h, 72 h, 7 days after remimazolam infusion, and on the day of successful extubation |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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