Trial · NCT04833023
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Richmond Agitation and Sedation Scale (RASS) score | 8 hours | The change in Richmond Agitation and Sedation Scale (RASS) score 8 hours after administration of either Haloperidol and Olanzapine. Minimum value is -5 which represents that the patient is in hypoactive delirium and is unarousable and maximum value is +4 with the higher score representing that the patient is in hyperactive delirium and is combative. The aim of the study is to reduce the hyperactive delirium to a score of 0 which represents patient is alert and calm. |
| Secondary | Comparing Patient and Family's concurrence on state of delirium with of the Diagnosis of Delirium from Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria for delirium. | 72 hours | There have not been any studies that looked at interviewing patients who are delirious about their acknowledgement and concurrence of their state of delirium. The investigators aim to interview patients by asking the patient 'Did you feel confused' and caregivers similarly by asking 'Do you feel that your loved one is Confused' as shown as an example below and compare this to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) criteria for delirium. Please ask the Patient the following question "Do you feel that you are confused?" 1. Yes/Sometimes 2. No 3. Not Sure/ Unable to answer Please ask the Family member or Caregiver the following question "Do you think the patient is confused?" 1\) Yes/Sometimes 2) No 3) Not sure/ Unable to answer |
| Secondary | Mean dose used of Haloperidol and Olanzapine | 72 hours | Mean doses of Haloperidol and Olanzapine used at 8hours / D1 / D2 / D3 from the first time-point that the study medication is administered to the patients |
| Secondary | Mean Time to control of Hyperactive Delirium | 72 hours | Mean Time to control of Hyperactive Delirium |
| Secondary | Rescue Psychotropic (Mean Doses): Midazolam | 72 hours | Rescue Psychotropic (Mean Doses): Midazolam |
| Secondary | Side-effects of Study Medications | 72 hours | Side-effects of Study Medications |
| Secondary | Survival time in days | 72 hours | Survival time in days |
| Secondary | Edmonton Symptom Assessment Score revised (ESAS-r) | 1 hour | Edmonton Symptom Assessment Score revised (ESAS-r) - At the point of recruitment Minimum value for the scale is 0 and maximum value for the scale is 10 with the higher value representing worse outcome. |
| Secondary | Memorial Delirium Assessment Score (MDAS) | 72 hours | Memorial Delirium Assessment Score (MDAS) - At the point of recruitment and after 72 hours It is a scale comprising of 10 items with scores of 0-3 for each question. Add up the score for all 10 questions and scores with more than or equal to 13 point indicates delirium. |
| Secondary | Richmond Agitation and Sedation Scale (RASS) score | 72 hours | Richmond Agitation and Sedation Scale (RASS) score: 8hours / 24hours (Day 1) / 48 hours (Day 2) / 72 hours (Day 3) Minimum value is -5 which represents that the patient is in hypoactive delirium and is unarousable and maximum value is +4 with the higher score representing that the patient is in hyperactive delirium and is combative. The aim of the study is to reduce the hyperactive delirium to a score of 0 which represents patient is alert and calm. |
| Secondary | Caregiver and Nurses Perception on the control of hyperactive delirium | 72 hours | Caregiver and Nurses Perception on the control of hyperactive delirium (5-point Likert Scale). Kindly refer to the example of the question below. The patient is less agitated as compared to 72 hours ago? (Clinician/Nurse): 1. \- Strongly Disagree 2. \- Disagree 3. \- Neutral 4. \- Agree 5. \- Strongly Agree The patient is less agitated as compared to 72 hours ago? (Family/Caregiver): 1. \- Strongly Disagree 2. \- Disagree 3. \- Neutral 4. \- Agree 5. \- Strongly Agree |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT04833023/registered