Trial · NCT06907173
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
NCT06907173, Phase 3, Recruiting, University of Virginia
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT). Trials, record NCT06907173. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06907173
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
- NCT number
- NCT06907173
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 770 participants, estimated
- Lead sponsor
- University of Virginia
- Conditions
- Status Epilepticus
- Interventions
- Levetiracetam (LEV) (60 mg/Kg) + 1 mg/kg Ketamine (KET), Levetiracetam (LEV) (60 mg/Kg) + 3 mg/kg Ketamine (KET), Levetiracetam (LEV) (60 mg/Kg)
- First posted
- 2025-04-02
- Last updated
- 2026-09-17
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Termination of SE | From 15 minutes after starting the study drug infusion, sustained for 60 minutes without using additional anti-seizure medication. | Termination of SE from 15 minutes after starting the study drug infusion, sustained for 60 minutes without using additional anti-seizure medication. Termination of SE is determined by (1) improving consciousness and absence of clinically apparent seizures at 60 minutes or (2) absence of any electrographic status epilepticus (ESE) after 15 minutes in those with EEG monitoring and no improvement in consciousness. |
| Secondary | Desirability of response (DOOR) outcome | 60 minutes after starting the study drug infusion | One secondary outcome will be a desirability of response (DOOR) outcome which is a composite efficacy measure evaluated on a graded scale from 1 to 5 at 60 minutes, as follows: * No clinically evident or electrographic seizures after 15 minutes, no rescue drugs, and improving mental status by 60 minutes * No clinically evident or electrographic seizures after 15 minutes, not intubated, but not improving mental status at 60 minutes * No clinically evident or electrographic seizures after 15 minutes, but intubated or use of additional seizures medications (including medications used for intubation) * Any clinically evident seizure or electrographic seizure requiring rescue medicine within the timeframe between 15 and 60 minutes * Life-threatening hypotension or cardiac arrhythmia or death within 60 minutes The Central Adjudication Core will determine the DOOR grade (1-5) based on clinical outcome data provided by the site and EEG data provided by the Central EEG Core. |
| Secondary | Endotracheal intubation | Within 60 minutes after start of the study drug infusion | Endotracheal intubation within 60 minutes of randomization (start of study drug infusion) and duration |
| Secondary | ICU duration | Up to 30 days after enrollment | ICU duration during the study period for those that are admitted to the ICU as abstracted from the hospital admission record |
| Secondary | Hospital length-of-stay (LOS) | Up to 30 days after enrollment | Hospital length-of-stay (LOS) from the ED as abstracted from the hospital admission record |
| Secondary | Late recurrent seizure | Between 60 minutes and 4 hours after the start of the study drug infusion | Number of participants with late recurrent seizure between 60 minutes and 4 hours after the start of the study drug infusion |
| Secondary | Time to termination of seizures | From the start of infusion of study drug to the cessation of electrographic seizure assessed up to 60 minutes from study drug initiation | The interval from the start of infusion of study drug to the cessation of electrographic seizure in those who meet the primary outcome |
| Secondary | Late seizures after requiring an anesthetic | Between 60 minutes and 24 hours after start of study drug infusion | Number of participants with late seizures after requiring an anesthetic between 60 minutes and 24 hours after start of study drug infusion |
| Secondary | All cause mortality | From the start of study drug infusion to hospital discharge or day 30 | All cause mortality to end of 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.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT06907173
GET https://conductscience.org/api/trials/v1/NCT06907173/registered