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

Primary Purpose

Hypoxia-Ischemia, Brain, Heart Arrest

Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Early cessation of sedation and TTM
Sponsored by
Medisch Spectrum Twente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoxia-Ischemia, Brain focused on measuring EEG, targeted temperature management (TTM)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rijnstate hospital
  • Medisch Spectrum Twente

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early cessation of sedation and TTM

Standard Care

Arm Description

Early cessation of sedation and targeted temperature management (TTM), with subsequent weaning from mechanical ventilation if appropriate (intervention group).

Standard care, including sedation and targeted temperature management (TTM) for at least 24-48 hours (control group).

Outcomes

Primary Outcome Measures

Mechanical ventilation time in hours

Secondary Outcome Measures

Length of ICU stay
Total sedation time
Need for re-intubation
Need for restarting sedation
Number of serious adverse events (SAEs)
Mortality
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
Neurological outcome measured at the Extended Glasgow Outcome Scale (GOSE)
The CPC ranges from 1 to 8, with higher scores meaning better neurological outcome.
Neurological outcome measured at the Cerebral Performance Category (CPC)
The CPC ranges from 1 to 5, with higher scores meaning worse neurological outcome.
Cognitive functioning
Montreal Cognitive Assessment (MOCA) score via videoconference. The MOCA ranges from 0 to 30, with higher scores meaning better cognitive functioning.

Full Information

First Posted
August 31, 2023
Last Updated
September 20, 2023
Sponsor
Medisch Spectrum Twente
Collaborators
Rijnstate Hospital, University of Twente
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1. Study Identification

Unique Protocol Identification Number
NCT06048796
Brief Title
Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest
Acronym
SELECT
Official Title
Early Cessation of Sedation and TTM in Patients With a Favourable EEG After Cardiac Arrest: a Feasibility and Safety Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
October 2026 (Anticipated)
Study Completion Date
October 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medisch Spectrum Twente
Collaborators
Rijnstate Hospital, University of Twente

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoxia-Ischemia, Brain, Heart Arrest
Keywords
EEG, targeted temperature management (TTM)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
A cluster randomized crossover design with two treatment arms (early cessation from sedation and TTM vs standard care).
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early cessation of sedation and TTM
Arm Type
Experimental
Arm Description
Early cessation of sedation and targeted temperature management (TTM), with subsequent weaning from mechanical ventilation if appropriate (intervention group).
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Standard care, including sedation and targeted temperature management (TTM) for at least 24-48 hours (control group).
Intervention Type
Other
Intervention Name(s)
Early cessation of sedation and TTM
Intervention Description
Early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate
Primary Outcome Measure Information:
Title
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).
Secondary Outcome Measure Information:
Title
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).
Title
Total sedation time
Time Frame
During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Title
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).
Title
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).
Title
Number of serious adverse events (SAEs)
Time Frame
at 3 and 6 months
Title
Mortality
Time Frame
at 30 days, 3 months and 6 months
Title
Complications during intensive care admission
Description
Number of pneumonia, sepsis (according to sepsis 3 criteria), bleeding (any cause), cardiac arrhythmia (any associated with hemodynamic compromise), new cardiac arrest and thrombopenia
Time Frame
During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).
Title
Neurological outcome measured at the Extended Glasgow Outcome Scale (GOSE)
Description
The CPC ranges from 1 to 8, with higher scores meaning better neurological outcome.
Time Frame
at 3 and 6 months
Title
Neurological outcome measured at the Cerebral Performance Category (CPC)
Description
The CPC ranges from 1 to 5, with higher scores meaning worse neurological outcome.
Time Frame
at 3 and 6 months
Title
Cognitive functioning
Description
Montreal Cognitive Assessment (MOCA) score via videoconference. The MOCA ranges from 0 to 30, with higher scores meaning better cognitive functioning.
Time Frame
at 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marleen Tjepkema, PhD
Phone
+31 53 487 2850
Email
m.tjepkema-cloostermans@mst.nl
Facility Information:
Facility Name
Rijnstate hospital
City
Arnhem
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeannette Hofmeijer, Prof.
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marleen Tjepkema, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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