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EEG Monitoring for Refractory Status Epilepticus

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Jul 31, 2026 → Jul 31, 2027
See other at-risk trials from Barts & The London NHS Trust

Record History

  1. Primary completion pushed from Jul 31, 2026 to Jul 31, 2027v7
  2. Primary completion date: Mar 2026 to Jul 31, 2026
    • Study completion date: Jan 2027 to Jul 31, 2027
    v6
  3. Trial status: Suspended to Recruiting
    • Site details revised
    v5
  4. Primary completion date: Mar 2024 to Mar 2026
    • Study completion date: Jan 2025 to Jan 2027
    v4
  5. Trial status: Recruiting to Suspended Sponsor's reason: Study suspended until funding is secured
    • Primary completion date: Mar 2022 to Mar 2024
    • Study completion date: Jan 2023 to Jan 2025
    • Site details revised
    v3
  6. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2020 to Mar 17, 2020
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a prospective randomized study to investigate the yield of continuous electroencephalogram (cEEG), as a diagnostic tool in intensive care unit (ICU), for patients with refractory status epilepticus (RSE) and the contribution of this test to the patient final outcome, compared with standard medical care. Specifically, the hypothesis is that the use of cEEG for patients with RSE will significantly reduce the length of in-hospital stay, mortality, and subsequent complications (such as infections or pressure ulcers). It is also predicted that quality of life will be higher following cEEG at 0, 3, 6 and 12 months after discharge. As there are currently no data available from previous studies assessing the impact of cEEG on markers of the final clinical outcome in patients with RSE, this study is going to start as a feasibility study, aiming to obtain initial data for the primary outcome measure, in order to perform a sample size calculation for a larger future trial. The pilot study will also assess the integrity of the study protocol, specifically the recruitment process and the consent procedure, and also determine the necessary costs for running a cEEG service in ICU for patients with RSE
Trial Details
NCT Number NCT04170491
Lead Sponsor Barts & The London NHS Trust
Conditions
(from sponsor)		 Status Epilepticus
Related terms Status Epilepticus
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov