Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06048796

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

Led by Medisch Spectrum Twente · Updated on 2024-05-13

40

Participants Needed

2

Research Sites

133 weeks

Total Duration

On this page

Sponsors

M

Medisch Spectrum Twente

Lead Sponsor

R

Rijnstate Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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).
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Rijnstate hospital

Arnhem, Gelderland, Netherlands, 6815AD

Actively Recruiting

2

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands, 7500KA

Actively Recruiting

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Research Team

M

Marleen C. Tjepkema-Cloostermans, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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