To estimate the feasibility and safety of early weaning from ICU treatment in patients after cardiac arrest and an early (< 12 h) favourable EEG pattern.
ID
Source
Brief title
Condition
- Encephalopathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure for the feasibility study will be the mechanical
ventilation time in hours.
Secondary outcome
Secondary outcome measures will be:
Feasibility:
- Length of ICU stay (days).
- Need for re-intubation.
- Need for restarting sedation
Safety:
- Number of Serious Adverse Events (SAEs) at 30 days, 3 months, and 6 months.
- Mortality at 30 days, 3 months, and 6 months.
- Number of pneumonia, sepsis (according to sepsis 3 criteria), bleeding (any
cause), cardiac arrhythmia (any associated with hemodynamic compromise), new
cardiac arrest and thrombopenia.
Neurological functional outcome:
- Extended Glasgow Outcome Scale (GOSE) at 3 and 6 months.
- Cerebral Performance Category (CPC) at 3 and 6 months.
Cognitive functioning:
- Montreal Cognitive Assessment (MOCA) via videocall or telephone score at 3
and 6 months.
Patient experience of the deferred consent procedure:
- Short questionnaire at 3 months.
Background summary
Comatose patients after cardiac arrest are treated on intensive care units with
sedative medication, targeted temperature management (TTM), mechanical
ventilation, and hemodynamic support. Despite substantial variation in the
severity of the encephalopathy and even lack of unequivocal evidence of
efficacy of sedation and TTM, all patients receive standard treatment. The
severity of the postanoxic encephalopathy can reliably be assessed with the
electroencephalogram (EEG). A continuous EEG pattern within the first 12 hours
after cardiac arrest (*favorable EEG*) is strongly associated with a good
neurological outcome and reflects a very mild or transient encephalopathy. We
hypothesize that this subgroup of patients, with a favorable EEG will not
benefit from prolonged sedation and TTM.
Study objective
To estimate the feasibility and safety of early weaning from ICU treatment in
patients after cardiac arrest and an early (< 12 h) favourable EEG pattern.
Study design
A non-randomized controlled intervention study with two treatment arms (early
cessation from sedation and TTM vs standard care).
Intervention
The intervention contrast will be early cessation of sedation and TTM, with
subsequent weaning from mechanical ventilation if appropriate (intervention
group) vs. standard care, including sedation and TTM for at least 24-48 hours
(control group).
Study burden and risks
The safety of early cessation of sedation and TTM in patients with a favorable
EEG directly after hospital admission (6-12 h after cardiac arrest), reflecting
relatively mild, if any, postanoxic encephalopathy is unknown. There are
diverse opinions on this topic. Some experts believe that anesthesia gives the
brain *rest or silence" and thereby promotes recovery from ischemia, but this
is not supported by any evidence and mechanisms of action are unclear. In
contrast, other experts advocate that the risks of protraction of sedation and
ventilation probably prevail in patients with spontaneous brain recovery
according to the EEG, since shortening sedation and ventilation might prevent
ICU-associated complications like pneumonia, circulatory compromise, and
delirium impelling a longer ICU and hospital stay.
Besides the potential risks or benefits from early cessation or protraction of
sedation and mechanical ventilation, the impact or burden of participating in
the study is very limited. The EEG is made as part of routine care and no
additional measurements are performed during the hospital stay. The follow-up
consists of two video- or phonecalls of about 30 minutes.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
Inclusion criteria
- Patients after cardiac arrest admitted to the ICU for treatment with
sedation, TTM and mechanical ventilation.
- Age 18 years or older.
- Continuous EEG measurement started within 12 hours after cardiac arrest.
- Favourable EEG pattern within 12 hours after arrest, defined as a continuous
background pattern (NVN, 2019; Ruijter et al., 2019).
- Possibility to stop sedative treatment within three hours after
identification of a favourable EEG pattern.
- Written informed consent (deferred).
Exclusion criteria
- A known history of another medical condition with limited life expectancy (<6
months).
- Any progressive brain illness, such as a brain tumour or neurodegenerative
disease.
- Pre-admission Glasgow Outcome Scale Extended score of 4 or lower.
- Reason other than neurological condition to continue sedation and/or
ventilation.
- Follow-up impossible due to logistic reasons.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT06048796 |
| CCMO | NL84714.100.23 |