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Trial · NCT03628391

Haloperidol for Delirium in Adult Critically Ill Patients

NCT03628391, Phase 3, Terminated, Erasmus Medical Center

3 sourcestrials-2026-11-12-0.4.0

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ConductScience Library. Haloperidol for Delirium in Adult Critically Ill Patients. Trials, record NCT03628391. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03628391

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Haloperidol for Delirium in Adult Critically Ill Patients
NCT number
NCT03628391
Status
Terminated
Phases
Phase 3
Enrollment
142 participants, actual
Lead sponsor
Erasmus Medical Center
Conditions
Delirium, Critical Illness, Intensive Care Psychosis, Cognitive Impairment, Cognitive Decline
Interventions
Haloperidol, Placebo
First posted
2018-08-14
Last updated
2022-05-11

Source ClinicalTrials.gov

Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
Primarydelirium- and coma-free dayswithin the first 14 days after randomisationdays without brain dysfunction (=delirium OR coma) while at the ICU
SecondaryCognitive deterioration: Global cognitive functioning3 and 12 monthsGlobal 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).
SecondaryCognitive deterioration: Verbal learning and memory3 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).
SecondaryCognitive deterioration: Semantic fluency3 and 12 monthsSemantic 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.
SecondaryCognitive deterioration: Working memory3 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.
SecondaryCognitive deterioration: Cognitive flexibility3 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.
SecondaryCognitive deterioration: Word retrieval3 and 12 monthsWord retrieval is tested with the Boston Naming Test (30-item version). The total score (range: 0-30) represents the amount of correct answered drawings.
SecondaryAnxiety and depression3 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.
SecondaryFunctional outcome3 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.
Secondarymortality28 days and 1 yearmortality

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.

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
32967873DERIVEDPubMed
37904241DERIVEDPubMed

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.

Tests4

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed asSource
Category FluencySecondary outcomeConductCognition
Digit Span TestSecondary outcomeConductCognition
Picture Naming TestSecondary outcomeConductCognition
Verbal LearningSecondary outcomeConductCognition

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT03628391

GET https://conductscience.org/api/trials/v1/NCT03628391/registered