Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest

Heart Arrest Clinical Trial

— SELECT  

Official title:

Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest: a Feasibility and Safety Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06048796
• Other study ID #: SELECT
• Secondary ID: NL84714.100.23
• Status: Recruiting
• Phase: N/A
• Start date: March 12, 2024
• Est. completion date: October 2026

Study information

• Verified date: May 2024
• Source: Medisch Spectrum Twente
• Contact: Marleen C. Tjepkema-Cloostermans, PhD
• Phone: 0031 534872850
• Email: m.tjepkema-cloostermans[@]mst.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is 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 (indicating no or mild postanoxic encephalopathy).

Description:

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. The investigators hypothesize that this subgroup of patients, with a favorable EEG will not benefit from prolonged sedation and TTM.

The objective of this study is 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. The study design is a cluster randomized crossover design with two treatment arms. 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). The investigators will include forty adult patients admitted to the ICU with postanoxic encephalopathy after cardiac arrest and an early (<12 hours) favorable EEG pattern.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2026
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Ischemia
• Heart Arrest
• Hypoxia
• Hypoxia-Ischemia, Brain

Intervention

Other:
• Early cessation of sedation and TTM
Early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate

Locations

Country	Name	City	State
Netherlands	Rijnstate hospital	Arnhem	Gelderland
Netherlands	Medisch Spectrum Twente	Enschede	Overijssel

Sponsors (3)

Lead Sponsor	Collaborator
Medisch Spectrum Twente	Rijnstate Hospital, University of Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mechanical ventilation time in hours		During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Secondary	Length of ICU stay		During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Secondary	Total sedation time		During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Secondary	Need for re-intubation		During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Secondary	Need for restarting sedation		During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Secondary	Number of serious adverse events (SAEs)		at 3 and 6 months
Secondary	Mortality		at 30 days, 3 months and 6 months
Secondary	Complications during intensive care admission	Number of pneumonia, sepsis (according to sepsis 3 criteria), bleeding (any cause), cardiac arrhythmia (any associated with hemodynamic compromise), new cardiac arrest and thrombopenia	During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Secondary	Neurological outcome measured at the Extended Glasgow Outcome Scale (GOSE)	The CPC ranges from 1 to 8, with higher scores meaning better neurological outcome.	at 3 and 6 months
Secondary	Neurological outcome measured at the Cerebral Performance Category (CPC)	The CPC ranges from 1 to 5, with higher scores meaning worse neurological outcome.	at 3 and 6 months
Secondary	Cognitive functioning	Montreal Cognitive Assessment (MOCA) score via videoconference. The MOCA ranges from 0 to 30, with higher scores meaning better cognitive functioning.	at 3 and 6 months