Trial · NCT02899156
Flumazenil for Hypoactive Delirium Secondary to Benzodiazepine Exposure
NCT02899156, Phase 4, Terminated, University of California, Davis; results first posted 2020-07-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Flumazenil for Hypoactive Delirium Secondary to Benzodiazepine Exposure. Trials, record NCT02899156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02899156
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Flumazenil for Hypoactive Delirium Secondary to Benzodiazepine Exposure
- NCT number
- NCT02899156
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 22 participants, actual
- Lead sponsor
- University of California, Davis
- Conditions
- Hypoactive Delirium
- Interventions
- Flumazenil, Placebo
- First posted
- 2016-09-14
- Last updated
- 2020-07-23
- Results first posted
- 2020-07-23
- Limitations and caveats
- A planned interim analysis led to the trial being stopped early based on the observed size effect and power analysis.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Delirium-free Days | up to 14 days after randomization | Defined by the number of days in the 14-day period after randomization that the patient was alive and not delirious (i.e. CAM-ICU negative). Zero delirium-free days will be observed for patients that die within the 14-day period. |
| Secondary | Number of Participants With Delirium Resolution | up to 14 days after randomization | defined by the proportion of patients who were delirium free at 14 days after randomization |
| Secondary | Intensive Care Unit Length of Stay | duration of admission to the intensive care unit | length of time that the patient was admitted to an intensive care unit service during the hospital stay |
| Secondary | Number of Mechanical Ventilator Free Days | up to 28 days after randomization | number of days within the first 28 days after enrollment that the patient was free from needing mechanical ventilation |
| Secondary | Occurrence of Agitation Requiring Use of Rescue Sedatives While on Study Infusion | up to 72 hours after the start of the infusion | number of times that a RASS score of + 2 to +4 occurred that did not resolve with decreasing study infusion |
| Secondary | Average Duration of Study Infusion | up to 72 hours after the start of the infusion | average duration of time patient was randomized to each infusion up to 72 hours |
| Secondary | Average Maximum Rate of Study Infusion | up to 72 hours after the start of the infusion | average maximum rate (ml/hr) during the 72 hours after study infusion |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Delirium-free Days | up to 14 days after randomization | One patient randomized to the flumazenil and one randomized to the placebo never received the study infusion. The patient in the flumazenil group died from a massive hemorrhage within 1 hour of infusion initiation, and it was deemed nonattributable to study infusion. Twenty patients were included in the final analysis. | days | MEDIAN |
| SECONDARY | Number of Participants With Delirium Resolution | up to 14 days after randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Intensive Care Unit Length of Stay | duration of admission to the intensive care unit | days | MEAN | |
| SECONDARY | Number of Mechanical Ventilator Free Days | up to 28 days after randomization | days | MEAN | |
| SECONDARY | Occurrence of Agitation Requiring Use of Rescue Sedatives While on Study Infusion | up to 72 hours after the start of the infusion | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Average Duration of Study Infusion | up to 72 hours after the start of the infusion | hours | MEAN | |
| SECONDARY | Average Maximum Rate of Study Infusion | up to 72 hours after the start of the infusion | milliliters per hour | MEAN |
Source ClinicalTrials.gov
Results by group14
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Delirium-free Days | Flumazenil Group | 12.7 | Inter-Quartile Range 7.2 to 13.2 | days | |
| Number of Delirium-free Days | Placebo Group | 9.2 | Inter-Quartile Range 0 to 10.2 | days | |
| Number of Participants With Delirium Resolution | Flumazenil Group | 9 | Participants | ||
| Number of Participants With Delirium Resolution | Placebo Group | 7 | Participants | ||
| Intensive Care Unit Length of Stay | Flumazenil Group | 7.8 | Standard Deviation 4.8 | days | |
| Intensive Care Unit Length of Stay | Placebo Group | 7 | Standard Deviation 6 | days | |
| Number of Mechanical Ventilator Free Days | Flumazenil Group | 23.6 | Standard Deviation 4.4 | days | |
| Number of Mechanical Ventilator Free Days | Placebo Group | 24.9 | Standard Deviation 5 | days | |
| Occurrence of Agitation Requiring Use of Rescue Sedatives While on Study Infusion | Flumazenil Group | 0 | Participants | ||
| Occurrence of Agitation Requiring Use of Rescue Sedatives While on Study Infusion | Placebo Group | 0 | Participants |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Flumazenil Group | 11 | |
| Overall Study | STARTED | Placebo Group | 11 | |
| Overall Study | COMPLETED | Flumazenil Group | 10 | |
| Overall Study | COMPLETED | Placebo Group | 10 | |
| Overall Study | NOT COMPLETED | Flumazenil Group | 1 | |
| Overall Study | NOT COMPLETED | Placebo Group | 1 |
Source ClinicalTrials.gov
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 totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Flumazenil Group | 1 | 11 |
| Total, all-cause mortality | Placebo Group | 0 | 11 |
| Total, other adverse events | Flumazenil Group | 0 | 11 |
| Total, other adverse events | Placebo Group | 0 | 11 |
| Total, serious adverse events | Flumazenil Group | 0 | 11 |
| Total, serious adverse events | Placebo Group | 0 | 11 |
Source ClinicalTrials.gov
Papers30
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Flumazenil Group vs Placebo Group: Occurrence of Agitation Requiring Use of Rescue Sedatives While on Study Infusion | Trial comparisons |
| Flumazenil Group vs Placebo Group: deaths from any cause | Trial comparisons |
| Flumazenil Group vs Placebo Group: Number of Participants With Delirium Resolution | Trial comparisons |
| Flumazenil Group vs Placebo Group: serious adverse events | Trial comparisons |
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/NCT02899156
GET https://conductscience.org/api/trials/v1/NCT02899156/papers?page=2