Trial · NCT00265616
Treatment of Refractory Status Epilepticus
NCT00265616, Phase 3, Terminated, Brigham and Women's Hospital; results first posted 2013-04-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Refractory Status Epilepticus. Trials, record NCT00265616. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00265616
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Refractory Status Epilepticus
- NCT number
- NCT00265616
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 23 participants, actual
- Lead sponsor
- Brigham and Women's Hospital
- Conditions
- Status Epilepticus
- Interventions
- propofol, thiopental/pentobarbital
- First posted
- 2005-12-15
- Last updated
- 2013-04-09
- Results first posted
- 2013-04-04
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Refractory Status Epilepticus Controlled With First Course of Study Drug | after return of continuous EEG activity (typically after 36 hours - 5 days) | Control of status epilepticus refractory to benzodiazepines and a first antiepileptic drug after administration of the study drug; dichotomous assessment (yes/no) |
| Secondary | Clinical Outcome at Day 21 | 21 days | Return to baseline clinical conditions (i.e.: no new handicap, no death) |
| Secondary | Patients With Infectious Complications Requiring Specific Treatment | 10 days | |
| Secondary | Patients With Hypotension Requiring Specific Treatment | 10 days | |
| Secondary | Patients With Propofol Infusion Syndrome | 10 days | Propofol infusion syndrome (PRIS) is a severe metabolic alteration with elevation of lactate, CK, and triglycerides. |
| Secondary | Intubation Time in Survivors | Up to 3 months |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Clinical Outcome at Day 21 | 21 days | participants | NUMBER | |
| SECONDARY | Patients With Infectious Complications Requiring Specific Treatment | 10 days | participants | NUMBER | |
| SECONDARY | Patients With Hypotension Requiring Specific Treatment | 10 days | participants | NUMBER | |
| SECONDARY | Patients With Propofol Infusion Syndrome | 10 days | participants | NUMBER | |
| PRIMARY | Refractory Status Epilepticus Controlled With First Course of Study Drug | after return of continuous EEG activity (typically after 36 hours - 5 days) | Number of patients fulfilling primary outcome criteria | participants | NUMBER |
| SECONDARY | Intubation Time in Survivors | Up to 3 months | days | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Outcome at Day 21 | Propofol | 5 | participants | ||
| Clinical Outcome at Day 21 | Thiopental/Pentobarbital | 3 | participants | ||
| Patients With Infectious Complications Requiring Specific Treatment | Propofol | 7 | participants | ||
| Patients With Infectious Complications Requiring Specific Treatment | Thiopental/Pentobarbital | 6 | participants | ||
| Patients With Hypotension Requiring Specific Treatment | Propofol | 7 | participants | ||
| Patients With Hypotension Requiring Specific Treatment | Thiopental/Pentobarbital | 5 | participants | ||
| Patients With Propofol Infusion Syndrome | Propofol | 1 | participants | ||
| Patients With Propofol Infusion Syndrome | Thiopental/Pentobarbital | 0 | participants | ||
| Refractory Status Epilepticus Controlled With First Course of Study Drug | Propofol | 6 | participants | ||
| Refractory Status Epilepticus Controlled With First Course of Study Drug | Thiopental/Pentobarbital | 2 | participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Propofol | 14 | |
| Overall Study | STARTED | Thiopental/Pentobarbital | 9 | |
| Overall Study | COMPLETED | Propofol | 14 | |
| Overall Study | COMPLETED | Thiopental/Pentobarbital | 9 | |
| Overall Study | NOT COMPLETED | Propofol | 0 | |
| Overall Study | NOT COMPLETED | Thiopental/Pentobarbital | 0 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| serious | propofol infusion syndrome (non fatal) | Cardiac disorders | Propofol | 1 | 14 | 1 |
| serious | propofol infusion syndrome (non fatal) | Cardiac disorders | Thiopental/Pentobarbital | 0 | 9 | 0 |
| serious | paralytic ileus (fatal) | Gastrointestinal disorders | Propofol | 0 | 14 | 0 |
| serious | paralytic ileus (fatal) | Gastrointestinal disorders | Thiopental/Pentobarbital | 1 | 9 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Propofol | ||
| Total, all-cause mortality | Thiopental/Pentobarbital | ||
| Total, other adverse events | Propofol | 0 | 14 |
| Total, other adverse events | Thiopental/Pentobarbital | 0 | 9 |
| Total, serious adverse events | Propofol | 1 | 14 |
| Total, serious adverse events | Thiopental/Pentobarbital | 1 | 9 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20878265 | RESULT |
Source PubMed
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Propofol vs Thiopental/Pentobarbital: Refractory Status Epilepticus Controlled With First Course of Study Drug | Trial comparisons |
| Propofol vs Thiopental/Pentobarbital: Patients With Hypotension Requiring Specific Treatment | Trial comparisons |
| Propofol vs Thiopental/Pentobarbital: Patients With Propofol Infusion Syndrome | Trial comparisons |
| Propofol vs Thiopental/Pentobarbital: Patients With Infectious Complications Requiring Specific Treatment | Trial comparisons |
| Propofol vs Thiopental/Pentobarbital: Clinical Outcome at Day 21 | Trial comparisons |
| Propofol vs Thiopental/Pentobarbital: 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/NCT00265616
GET https://conductscience.org/api/trials/v1/NCT00265616/registered