Trial · NCT02345902
Treatment of Hypoactive Delirium and Outcome Measures
NCT02345902, Phase 3, Unknown, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Hypoactive Delirium and Outcome Measures. Trials, record NCT02345902. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02345902
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Hypoactive Delirium and Outcome Measures
- NCT number
- NCT02345902
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 60 participants, estimated
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Conditions
- Hypoactive Delirium
- Interventions
- Haloperidol, Placebo, non-pharmacologic measures
- First posted
- 2015-01-26
- Last updated
- 2017-04-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in delirium severity | Participants will be followed at an expected average of nine days | Reduction of 50% from the basal DOSS score |
| Secondary | Necessity of additional open label haloperidol doses to control delirium symptoms | Participants will be followed at an expected average of nine days | In case the patient develops a hyperactive state will receive haloperidol in an open label dose, 1 mg that could be repeated every 4 hours in case the agitation persists, for a maximum daily dose of 6 mg. In this way, the dose will never exceed the recommended 10 mg dose per day. If the patient persists with a hypoactive state (absence of improvement on the DOSS score), we will increase the dose to 2.5 mg or half a tablet (of haloperidol or placebo q.d.) or 3.75 mg,three quarters of a tablet ( of haloperidol or placebo q.d.) |
| Secondary | Delirium duration | Participants will be followed at an expected average of nine days | Using the DOSS basal score and the CAM |
| Secondary | Perceived stress | At 24 hours after delirium remission | in patients, health staff and caregivers of both groups using the delirium experience questionnaire |
| Secondary | Posttraumatic stress disorder | At 6 months after delirium remission | In patients of both groups using the posttraumatic stress disorder section of the Mini International Neuropsychiatry Interview |
| Secondary | Cognitive impairment as assessed by Montreal Cognitive Assessment (MoCA) <24 points | At 6 months after delirium remission | Number of patients with \<24 points in the Montreal Cognitive Assessment at 6 months after delirium remission, as compared with the number of patients with scoring \>3.5 points in the Informant Questionnaire on Cognitive Decline in the Elderly, as an estimate of the baseline (pre-delirium) state |
| Secondary | Cerebral blood flow as assessed by transcranial Doppler | At baseline and after 24 h of delirium remission | in patients of both groups using a cerebral ultrasound |
| Secondary | Side effects associated with either intervention | Participants will be followed at an expected average of nine days | We will list all adverse reactions associated with haloperidol (extra pyramidal effects, arrhythmias, hypersensitivity to the drug or corrected QT interval prolongation), the medication will be stopped in case of the appearance of an life-threatening reaction. We will consider this case when a patient needs ventilator support, use of cardiac amines, hemodialysis or the use of the Intensive Care Unit. These conditions will require opening the masking and exit the patient from the study. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers16
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02345902
GET https://conductscience.org/api/trials/v1/NCT02345902/registered