Clinical Trial Details
— Status: Suspended
Administrative data
| NCT number |
NCT04170491 |
| Other study ID # |
240176 |
| Secondary ID |
|
| Status |
Suspended |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 17, 2020 |
| Est. completion date |
January 2027 |
Study information
| Verified date |
April 2024 |
| Source |
Barts & The London NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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
Description:
The study is a randomised feasibility study.
The patients participating in the study will be randomised 1:1 in two groups. The
randomisation will be stratified by three status epilepticus (SE) aetiologies a) previous
epilepsy b) acute central nervous system insult c) cryptogenic/ unknown.
The standard medical care group (Control group) will receive sequential portable
electroencephalograms (EEGs), performed according to the clinical demand. The treatment group
(cEEG group) will have cEEG, which will continue until 24 hours after cessation of clinical
and electrical seizure activity. The patients will be treated by the same medical team of
neurologists or neurointensivists, according to the same guidelines.
Clinical data will be collected from observation of in-patient medical records. The
information will include demographics i.e. age, gender and ethnicity group, information about
previous medical history and specifically previous history of epilepsy. The investigators
will record the type of epilepsy, the type of previous seizures, their frequency, previous
admissions due to SE and current and previously used antiepileptic drugs. These data can be
obtained either by the patient or the next of kin and if the patient is followed up in the
local epilepsy service, the required data may be obtained from the medical records.
Regarding the acute presentation of status epilepticus, data will be collected regarding the
date and the time of diagnosis of SE, the date of seizure onset, the level of consciousness
on presentation, the type of seizures during SE (i.e. focal motor, generalised motor, absence
etc) and SE aetiology, if available. If the SE is diagnosed by EEG as non-convulsive, the
date of the diagnosis will be recorded. The types of seizures during the course of SE will be
recorded, as well as the antiepileptic drugs and sedation used, including the doses. The SE
severity score (STESS) will be calculated early during the patient admission to ICU. The date
that the patient was fit for discharge from ICU will be obtained, as well as the date of
discharge from hospital. It is noted that the date the patient is fit for discharge from ICU
is not always the same as the actual date of ICU discharge. The data will also include
in-hospital and 30-days mortality, the time until seizure control and the reported hospital
acquired complications and specifically healthcare-associated infections, pressure injuries,
falls resulting in fractures or injuries, respiratory complications, venous thromboembolism
and medication complications. The quality of life index will be assessed with the health
questionnaire introduced by EuroQol Group (version EQ-5D-5L), at 0, 3 ,6 and 12 months post
discharge and/ or the Quality of Life in Epilepsy questionnaire (QOLIE), which will be mailed
to the patients. If the patient is not able to provide this information in writing, these
data will be collected with brief telephone interview.
The observational data will be collected by the research nurse and will be transferred to the
case report form (CRF). The specific information, regarding the seizure types and the seizure
aetiology, will require input from the medical team and specifically the neurologist, the
neurointensivist and the clinical neurophysiologist. The information gather will be reviewed
and supervised by the Principal Investigator (PI).
The data regarding the hospital costs for each patient will be collected after the patient's
discharge and will be based on the specific coding of all medical, diagnostic and therapeutic
interventions registered for each patient, taking into account the additional time required
for assessing cEEG data. The clinical neurophysiologist and the physiologist will log their
clinical activity time required for reviewing the cEEG recordings.
The data will be transferred to CRF and the length of ICU and in-hospital stay and the
quality of life measures will be compared between groups in order to identify differences in
the final outcome between the control and the cEEG groups. Similarly, the costs for
management of the two patient groups will be compared.
The calculation of the sample size for the larger study will be performed after the
collection of 40 cases.
