EEG Monitoring for Refractory Status Epilepticus

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorBarts & The London NHS Trust

About this trial

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

Eligibility criteria

Qualifiers

• Patients aged > 16 years

Consent obtained according to Mental Capacity Act 2005

Patients admitted to ICU for treatment of status epilepticus or admitted for another reason and diagnosed with SE during their admission

Tonic-clonic SE lasting longer than 5 minutes,

Disqualifiers

Anoxic brain injury

Trial design

Treatments tested in this trial

  • Continuous EEG

Treatment groups

40 Participants
are divided into 2 treatment groups

Sponsors and collaborators