An interventional study of Early cessation of sedation and TTM in Hypoxia-Ischemia, Brain and Heart Arrest, sponsored by Medisch Spectrum Twente. Recruiting at 2 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by Medisch Spectrum Twente · Not applicable, Interventional, and Treatment
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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).
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.
261 studies on the registry are indexed under Hypoxia-Ischemia, Brain; 94 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 156 interventional studies indexed under Hypoxia-Ischemia, Brain.
Browse Hypoxia-Ischemia, Brain studies →Medisch Spectrum Twente is the lead sponsor of 23 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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, including sedation and targeted temperature management (TTM) for at least 24-48 hours (control group).
Early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate
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).
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).
Total sedation time
Time frame: 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).
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).
Number of serious adverse events (SAEs)
Time frame: at 3 and 6 months
Mortality
Time frame: at 30 days, 3 months and 6 months
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
Time frame: 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)
The CPC ranges from 1 to 8, with higher scores meaning better neurological outcome.
Time frame: at 3 and 6 months
Neurological outcome measured at the Cerebral Performance Category (CPC)
The CPC ranges from 1 to 5, with higher scores meaning worse neurological outcome.
Time frame: at 3 and 6 months
Cognitive functioning
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
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2024 (actual). Primary completion is estimated for Oct 2026, 31 months after the start.
Of 46 non-industry interventional studies with no phase under Hypoxia-Ischemia, Brain, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 63. This study's planned 31 months is close to that.
Counting every sponsor, half of 47 studies reached it within 33 months; a quarter within 19 and three quarters within 63.
How these figures are worked out, and which studies are left out of them.
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Medisch Spectrum Twente