NCT06048796

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Mar 2024

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Mar 2024Oct 2026

First Submitted

Initial submission to the registry

August 31, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

March 12, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

2.6 years

First QC Date

August 31, 2023

Last Update Submit

May 10, 2024

Conditions

Hypoxia-Ischemia, BrainHeart Arrest

Keywords

EEGtargeted temperature management (TTM)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Length of ICU stay

    During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).

  • Total sedation time

    During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).

  • Need for re-intubation

    During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days).

  • Need for restarting sedation

    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)

    at 3 and 6 months

  • +5 more secondary outcomes

Study Arms (2)

Early cessation of sedation and TTM

EXPERIMENTAL

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

Standard Care

NO INTERVENTION

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

Interventions

Early cessation of sedation and TTMOTHER

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

Early cessation of sedation and TTM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rijnstate hospital

Arnhem, Gelderland, 6815AD, Netherlands

RECRUITING

Medisch Spectrum Twente

Enschede, Overijssel, 7500KA, Netherlands

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, BrainHeart Arrest

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesHypoxia, BrainVascular DiseasesCardiovascular DiseasesHypoxiaSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsHeart Diseases

Central Study Contacts

Marleen C. Tjepkema-Cloostermans, PhD

CONTACT

0031 534872850m.tjepkema-cloostermans@mst.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A cluster randomized crossover design with two treatment arms (early cessation from sedation and TTM vs standard care).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Technical Physician Specialist

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 21, 2023

Study Start

March 12, 2024

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

NL(2)