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| ID | Type | Description | Link |
|---|---|---|---|
| NL84714.100.23 | Registry Identifier | ToetsingOnline |
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| Name | Class |
|---|---|
| Rijnstate Hospital | OTHER |
| University of Twente | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Standard Care | No Intervention | Standard care, including sedation and targeted temperature management (TTM) for at least 24-48 hours (control group). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early cessation of sedation and TTM | Other | Early cessation of sedation and TTM, with subsequent weaning from mechanical ventilation if appropriate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mechanical ventilation time in hours | During the complete ICU admission (from admission to the ICU until discharge from the ICU, up to 30 days). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marleen C. Tjepkema-Cloostermans, PhD | Contact | 0031 534872850 | m.tjepkema-cloostermans@mst.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate hospital | Recruiting | Arnhem | Gelderland | 6815AD | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42359664 | Derived | Bhat N, Amorim E. Cost-Effectiveness of EEG Monitoring in Hypoxic-Ischemic Brain Injury After Cardiac Arrest. J Clin Neurophysiol. 2026 May 7. doi: 10.1097/WNP.0000000000001261. Online ahead of print. |
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| ID | Term |
|---|---|
| D020925 | Hypoxia-Ischemia, Brain |
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D002545 | Brain Ischemia |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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A cluster randomized crossover design with two treatment arms (early cessation from sedation and TTM vs standard care).
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| 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 |
| Mortality | 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 | 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. | 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. | 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. | at 3 and 6 months |
| Medisch Spectrum Twente | Recruiting | Enschede | Overijssel | 7500KA | Netherlands |
|
| D009422 | Nervous System Diseases |
| D002534 | Hypoxia, Brain |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000860 | Hypoxia |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |