Trial · NCT01211522
The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study
NCT01211522, Phase 3, Completed, Vanderbilt University Medical Center; results first posted 2019-08-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study. Trials, record NCT01211522. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01211522
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study
- NCT number
- NCT01211522
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 566 participants, actual
- Lead sponsor
- Vanderbilt University Medical Center
- Conditions
- Delirium, Impaired Cognition, Long Term Psychologic Disorders
- Interventions
- Haloperidol, Ziprasidone, Placebo
- First posted
- 2010-09-29
- Last updated
- 2019-11-18
- Results first posted
- 2019-08-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Delirium/Coma-free Days (DCFDs) | 14 days | Defined as the number of days during the 14-day intervention period (beginning on the day of randomization) that the patient was alive and experienced neither delirium nor coma. |
| Secondary | Mortality | 30-day and 90-day | Deaths within the specified timeframe |
| Secondary | Delirium Duration | 14 days | Duration of delirium during the intervention period |
| Secondary | Number of Participants With Torsades de Pointes | 14 days plus 4-day post-study drug period (if longer than 14 days) | |
| Secondary | Number of Participants With Extrapyramidal Symptoms | 14 days plus 4-day post-study drug period (if longer than 14 days) | |
| Secondary | Number of Participants With Neuroleptic Malignant Syndrome | 14 days plus 4-day post-study drug period (if longer than 14 days) | |
| Secondary | Time to Liberation From Mechanical Ventilation | 30 days | Days from randomization to successful liberation from mechanical ventilation, where "successful" indicates that liberation was followed by at least 48 hours alive and without reinitiation of invasive or noninvasive ventilation. |
| Secondary | Time to Final ICU Discharge | 90 days | Days from randomization to final, successful ICU discharge, where "successful" indicates that discharge was followed by at least 48 hours alive. "ICU discharge" is represented by readiness for ICU discharge indicated by a physician order for transfer to a lower level of care even if a bed availability problems prevent actual discharge from the ICU. |
| Secondary | Time to ICU Readmission | 90 days after first ICU discharge | Days from first ICU discharge to next ICU readmission. |
| Secondary | Time to Hospital Discharge | 90 days | Days from randomization to successful hospital discharge, where "successful" indicates that discharge was followed by at least 48 hours alive. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Delirium/Coma-free Days (DCFDs) | 14 days | days | MEDIAN | |
| SECONDARY | Mortality | 30-day and 90-day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Delirium Duration | 14 days | days | MEDIAN | |
| SECONDARY | Number of Participants With Torsades de Pointes | 14 days plus 4-day post-study drug period (if longer than 14 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Extrapyramidal Symptoms | 14 days plus 4-day post-study drug period (if longer than 14 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Neuroleptic Malignant Syndrome | 14 days plus 4-day post-study drug period (if longer than 14 days) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Liberation From Mechanical Ventilation | 30 days | days | MEDIAN | |
| SECONDARY | Time to Final ICU Discharge | 90 days | days | MEDIAN | |
| SECONDARY | Time to ICU Readmission | 90 days after first ICU discharge | Time to ICU readmission reported among those who were readmitted to the ICU | days | MEDIAN |
| SECONDARY | Time to Hospital Discharge | 90 days | days | MEDIAN |
Source ClinicalTrials.gov
Results by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Delirium/Coma-free Days (DCFDs) | Haloperidol | 8 | Inter-Quartile Range 0 to 11 | days | |
| Delirium/Coma-free Days (DCFDs) | Ziprasidone | 8 | Inter-Quartile Range 2 to 11 | days | |
| Delirium/Coma-free Days (DCFDs) | Placebo | 7 | Inter-Quartile Range 0 to 11 | days | |
| Mortality | Haloperidol | 30-day mortality | 50 | Participants | |
| Mortality | Ziprasidone | 30-day mortality | 53 | Participants | |
| Mortality | Placebo | 30-day mortality | 50 | Participants | |
| Mortality | Haloperidol | 90-day mortality | 73 | Participants | |
| Mortality | Ziprasidone | 90-day mortality | 65 | Participants | |
| Mortality | Placebo | 90-day mortality | 63 | Participants | |
| Delirium Duration | Haloperidol | 4 | Inter-Quartile Range 2 to 7 | days |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Haloperidol | 192 | |
| Overall Study | STARTED | Ziprasidone | 190 | |
| Overall Study | STARTED | Placebo | 184 | |
| Overall Study | COMPLETED | Haloperidol | 189 | |
| Overall Study | COMPLETED | Ziprasidone | 183 | |
| Overall Study | COMPLETED | Placebo | 179 | |
| Overall Study | NOT COMPLETED | Haloperidol | 3 | |
| Overall Study | NOT COMPLETED | Ziprasidone | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 5 |
Source ClinicalTrials.gov
Adverse events15
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Oversedation | Nervous system disorders | Haloperidol | 42 | 192 | |
| other | Oversedation | Nervous system disorders | Ziprasidone | 50 | 190 | |
| other | Oversedation | Nervous system disorders | Placebo | 46 | 184 | |
| other | Prolonged QTc | Cardiac disorders | Haloperidol | 13 | 192 | |
| other | Prolonged QTc | Cardiac disorders | Ziprasidone | 20 | 190 | |
| other | Prolonged QTc | Cardiac disorders | Placebo | 10 | 184 | |
| serious | Torsades de pointes | Cardiac disorders | Haloperidol | 2 | 192 | |
| serious | Torsades de pointes | Cardiac disorders | Ziprasidone | 1 | 190 | |
| serious | Torsades de pointes | Cardiac disorders | Placebo | 1 | 184 | |
| serious | Neuroleptic malignant syndrome | Nervous system disorders | Haloperidol | 0 | 192 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Haloperidol | 73 | 192 |
| Total, all-cause mortality | Ziprasidone | 65 | 190 |
| Total, all-cause mortality | Placebo | 63 | 184 |
| Total, other adverse events | Haloperidol | 55 | 192 |
| Total, other adverse events | Ziprasidone | 70 | 190 |
| Total, other adverse events | Placebo | 56 | 184 |
| Total, serious adverse events | Haloperidol | 3 | 192 |
| Total, serious adverse events | Ziprasidone | 1 | 190 |
| Total, serious adverse events | Placebo | 1 | 184 |
Source ClinicalTrials.gov
Papers5
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/NCT01211522
GET https://conductscience.org/api/trials/v1/NCT01211522/results?page=2