Trial · NCT04684238
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Minimum of 12 hours up to 48 hours (± 6 hours). | Full Analysis set (FAS): The FAS included all randomised patients who received IMP and had at least a 6-hour sedation period and at least 3 blinded COMFORT-B-assessments. The FAS followed the intention-to-treat principle, i.e., patients were analysed according to the treatment group they were assigned to at randomisation. The main statistical analysis was performed on this population. | Percentage of time | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Time of Adequately Maintained Sedation Depth up to 48 Hours (± 6 Hours) | Minimum of 12 hours up to 48 hours (± 6 hours). | The PP analysis set included all patients in the FAS without any major protocol deviation affecting the primary analysis. To be included in the PP analysis patients had to have been sedated for at least 12h (which was interpreted as 12 h of study sedative treatment from start of IMP), with at least 50% of the planned COMFORT-B assessments performed. | Percentage of time | LEAST_SQUARES_MEAN |
| SECONDARY | Compare the Use of Opioids | From first blinded COMFORT-B assessment (at +2 h from start of study drug initiation) to end of the study treatment period | The FAS included all randomised patients who received IMP and had at least a 6-hour sedation period and at least 3 blinded COMFORT-B-assessments. The FAS followed the intention-to-treat (ITT) principle, i.e., patients were analysed according to the treatment group they were assigned to at randomisation. | μg/kg/h | LEAST_SQUARES_MEAN |
| SECONDARY | Compare the Use of Opioids | Last 4 hours of study treatment compared to first 4 hours of study treatment after first blinded COMFORT-B assessment (at +2 h from start of study drug initiation). | FAS: Patients with 8 hours or more of study treatment from first blinded COMFORT-B assessment. | μg/kg/h | LEAST_SQUARES_MEAN |
| SECONDARY | Compare Time From End of Study Drug Administration to Extubation | From end of study drug administration to extubation or end of extubation attempt | Subgroup of patients with endotracheal tube where wake-up was initiated at end of study treatment | hour | MEAN |
| SECONDARY | Compare the Proportion of Time With Spontaneous Breathing | From initiation of study drug treatment to End of study treatment (up to 48h +/- 6h) | Full Analysis Set | proportion of time | LEAST_SQUARES_MEAN |
| SECONDARY | Evaluate Haemodynamic Effect as Indicated by Need for Additional Inotropic/Vasopressor Agent | From start of study treatment to end of study treatment (up to 48h +/- 6h) | Safety analysis set | Change from baseline in VIS | MEAN |
| SECONDARY | Evaluate the Number of Patients With Withdrawal Symptom | From > 96 hours sedation (including pre-study sedation period) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Evaluate the Frequency of Delirium | Patients admitted to the ICU ≥48 hours (including period prior to study enrolment) until the end of the 48-hour post study treatment monitoring or ICU discharge, whichever comes first. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Evaluate the Frequency of Neurological Symptoms or Psychomotor Dysfunction | During study treatment and up to 48 hours after discontinuation of isoflurane and midazolam | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Compare the 30 Days/Hospital Mortality | From start of study treatment up to 30 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Compare Ventilator-free Days | From start of study treatment up to 30 days | Safety analysis set (only patients not withdrawn prior to day 30) | Number of ventilator-free days | MEAN |
| SECONDARY | Compare the Time in ICU/Hospital | From start of study treatment up to 30 days | Safety analysis set (only patients not withdrawn prior to day 30) | Number of ICU days | MEAN |
| SECONDARY | Compare ICU-free Days | From start of study treatment up to 30 days | Safety analysis set (only patients not withdrawn prior to day 30). This was a secondary safety endpoint. Patients who died before day 30 were not considered withdrawals. For these patients, the days in ICU until day of death were considered ICU days. | Number of days alive and not in the ICU | MEAN |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04684238/outcomes