Trial · NCT03628391
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | delirium- and coma-free days | within the first 14 days after randomisation | days without brain dysfunction (=delirium OR coma) while at the ICU |
| Secondary | Cognitive deterioration: Global cognitive functioning | 3 and 12 months | Global cognitive functioning as assessed with the Montreal Cognitive Assessment (MOCA). Total score will be reported, with a range of 0-30 (higher values representing better cognitive functioning). |
| Secondary | Cognitive deterioration: Verbal learning and memory | 3 and 12 months | Auditory-verbal learning and memory will be assessed with the Rey Auditory Verbal Learning Test. Three subscores will be reported: total correct words in 5 trials (range: 0 -75), total correct words after delay (range: 0-15) and total correct words at recognition (range: 0-30). |
| Secondary | Cognitive deterioration: Semantic fluency | 3 and 12 months | Semantic fluency will be tested with the Semantic Category Fluency Test. The amount of animals given within a time of 60 seconds will represent the score. |
| Secondary | Cognitive deterioration: Working memory | 3 and 12 months | Working memory will be assessed using the Wechsler Adult Intelligence Scale - Third Edition (WAIS-III). Subscales will be reported for both digit span under forward and backward recall conditions. In addition, a total score will be reported, which equals the sum of both separate digit spans. |
| Secondary | Cognitive deterioration: Cognitive flexibility | 3 and 12 months | Cognitive flexibility, one of the executive funcions, will be assessed with the Trialmaking tests A and B. The total amount of seconds needed to finish each test will be reported, with less seconds needed representing better cognitive flexibility. |
| Secondary | Cognitive deterioration: Word retrieval | 3 and 12 months | Word retrieval is tested with the Boston Naming Test (30-item version). The total score (range: 0-30) represents the amount of correct answered drawings. |
| Secondary | Anxiety and depression | 3 and 12 months | Anxiety and depression will be assessed with the Hospital Anxiety and Depression Scale (HADS). Two subscales will be reported, one for anxiety symptoms (range: 0-21) and one for depression symptoms (range: 0-21). Higher values represent a worse outcome. A subscore \>8 indicates anxiety or depression, respectively. |
| Secondary | Functional outcome | 3 and 12 months | Health-related quality of life will be assessed with the Short Form-35 (SF-36). Nine subscales will be reported on a 0 - 100 scale: physical functioning, role functioning - physical, bodily pain, general health, vitality, social functioning, role functioning - emotional, mental health and reported health transition. Higher values represent a better health-related quality of life. |
| Secondary | mortality | 28 days and 1 year | mortality |
| Secondary | length of stay at ICU | days of ICU stay (time in days from ICU admission until ICU discharge). Assessed up to a maximum of 12 months after randomisation (end of follow-up period). | length of stay at ICU (days) |
| Secondary | Adverse drug associated events: prolonged QTc by EKG | while on study drug treatment during study period at ICU (up to 14 days after randomisation) | prolonged QTc by EKG (ms) |
| Secondary | Adverse drug associated events: muscle rigidity and other associated movements disorders | while on study drug treatment during study period at ICU (up to 14 days after randomisation) | muscle rigidity and other associated movements disorders \[measured with the Simpson Angus Scale\] |
| Secondary | Adverse drug associated events: ventricular arrhythmia's | during study period at ICU (up to 14 days after randomisation) | ventricular arrhythmia's including torsade de pointes |
| Secondary | Patients' memories related to their ICU stay | at discharge from hospital (up to a maximum of 12 months after randomisation = end of follow-up period) and 3 months after randomisation | Patients' memories for their ICU stay will be evaluated with the ICU Memory Tool (ICU-MT). Subscores will be reported for factual memories (range: 0-11), delusion memories (range: 0-6) and memories of feelings (range: 0-4). |
| Secondary | Patients' and family-members' experiences related to delirium | at discharge from hospital (up to a maximum of 12 months after randomisation = end of follow-up period) and 3 months after randomisation | Delirium recall and distress related to the delirium episode will be assessed with the Delirium Experience Questionnaire (DEQ). Scores will represent whether patients remember their delirium episode. In addition, a score representing delirium-related distress levels (range: 0-4, with higher values representing more distress) will be reported for both patients and family-members. |
| Secondary | Caregiver Strain | at 3 months after randomisation | The strain experienced by family-members or relatives will be assessed with the Caregiver Strain Index. A total score (range: 0-13) will be reported, with higher values representing higher experienced strain. |
| Secondary | Posttraumatic stress syndrome | at 3 months after randomisation | Posttraumatic stress symptoms in patients and families will be assessed with the Impact of Event Scale - Revised (IES-R). A mean total IES-R score will be reported (range: 0-4), with posttraumatic stress disorder defined as a mean IES-R score ≥ 1.6. In addition, subscores will be reported for intrusion, avoidance and hyperarousal (range: 0-4). |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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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