EEG Monitoring for Refractory Status Epilepticus

Recruiting now · Not applicable

Conditions studied: Status Epilepticus

In brief

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

Key facts

Study ID

NCT04170491

Run by

Barts & The London NHS Trust

People needed

40

Starts

2020-03-17

Expected to finish

2027-07-31

Last updated by the study team

2026-05-08

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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
• Convulsive Status epilepticus defined by either:
• Tonic-clonic SE lasting longer than 5 minutes,
• Focal SE with impaired consciousness lasting longer than 10 minutes
• or Non-Convulsive SE according to Salzburg consensus criteria
• Status epilepticus that continues despite treatment with benzodiazepine and one antiepileptic medication

You may not qualify if…

• Anoxic brain injury

Where it is running

• Royal London Hospital — London, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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