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

May 10, 2024 updated by: Marleen Tjepkema-Cloostermans, Medisch Spectrum Twente

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Netherlands
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815AD
        • Recruiting
        • Rijnstate Hospital
        • Contact:
    • Overijssel
      • Enschede, Overijssel, Netherlands, 7500KA
        • Recruiting
        • Medisch Spectrum Twente
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early cessation of sedation and TTM
Early cessation of sedation and targeted temperature management (TTM), with subsequent weaning from mechanical ventilation if appropriate (intervention group).
Other: Early cessation of sedation and TTM
Early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate
No Intervention: Standard Care
Standard care, including sedation and targeted temperature management (TTM) for at least 24-48 hours (control group).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mechanical ventilation time in hours
Time Frame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of ICU stay
Time Frame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Total sedation time
Time Frame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Need for re-intubation
Time Frame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Need for restarting sedation
Time Frame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Number of serious adverse events (SAEs)
Time Frame: at 3 and 6 months
at 3 and 6 months
Mortality
Time Frame: at 30 days, 3 months and 6 months
at 30 days, 3 months and 6 months
Complications during intensive care admission
Time Frame: During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
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).
Neurological outcome measured at the Extended Glasgow Outcome Scale (GOSE)
Time Frame: at 3 and 6 months
The CPC ranges from 1 to 8, with higher scores meaning better neurological outcome.
at 3 and 6 months
Neurological outcome measured at the Cerebral Performance Category (CPC)
Time Frame: at 3 and 6 months
The CPC ranges from 1 to 5, with higher scores meaning worse neurological outcome.
at 3 and 6 months
Cognitive functioning
Time Frame: at 3 and 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medisch Spectrum Twente

Collaborators

Rijnstate Hospital
University of Twente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 20, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 10, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SELECT (Other Identifier: Folktandvården Stockholms län AB)
  • NL84714.100.23 (Registry Identifier: ToetsingOnline)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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