P25/30 SSEPs and Neurological Prognosis After Cardiac Arrest
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|ClinicalTrials.gov Identifier: NCT03881865|
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 21, 2019
Early recorded P25/30 somatosensory evoked potentials are associated with neurologic prognosis of comatose survivors after out of hospital cardiac arrest.
Prospective, observational, non-interventional, study - prospective collection of data and interpretation. Analysis of the data and assessment of prognostic value of the P25/30 in critically ill patients post cardiac arrest.
To be the first attempt to validate the prognostic potential of early recording [between 24-36 hours post Return Of Spontaneous Circulation] of P25/30 potentials in comatose survivors who are admitted to a British Intensive care unit after out of hospital cardiac arrest and who are not treated by hypothermic targeted temperature management.
[Validation of the prognostication significance of P25/30 Somatosensory Evoked Potentials in predicting neurologic outcome in comatose survivors post out of hospital cardiac arrest].
Primary Endpoint: Neurologic outcome assessed by Cerebral Performance Category score at hospital discharge.
Secondary endpoints: Mortality at hospital discharge and 28 days [which occurs first], comparison of prognostic benefit of N20 and P25/30 based multimodal prognostic models.
Comatose survivors, after out of hospital cardiac arrest, treated in Derriford Hospital ICU, Penrose and Pencarrow wards.
Adults [>18 years old], out of hospital cardiac arrest, comatose after Return Of Spontaneous Circulation, admission to intensive care Estimated Duration:36 months
|Condition or disease|
|Out-Of-Hospital Cardiac Arrest|
|Study Type :||Observational|
|Estimated Enrollment :||190 participants|
|Official Title:||P25/30 Somatosensory Evoked Potentials Are Associated With Neurological Prognosis of Comatose Survivors After Out of Hospital Cardiac Arrest|
|Actual Study Start Date :||October 8, 2018|
|Estimated Primary Completion Date :||October 6, 2021|
|Estimated Study Completion Date :||October 6, 2021|
- Cerebral Performance Category [CPC] score [ Time Frame: up to 30 days after cardiac arrest ]Neurological status of the participants assessed by the use of CPC score. CPC has 5 different scores describing the neurological outcome. CPC score 1: Full recovery or mild disability CPC score 2: Moderate Disability but independent in activities of daily living CPC score 3: Severe disability - Dependent in activities of daily living CPC score 4: persistent vegetative state CPC score 5: Death CPC scores 1 and 2 are considered positive [good] neurological outcomes, whereas scores 3-5 are considered negative [poor] neurological outcomes.
- Mortality [ Time Frame: up to 30 days after cardiac arrest ]Number of patients that died during the study period
- Correlation between P25/30 somatosensory evoked potentials presence and favourable prognosis [ Time Frame: Up to 30 days after cardiac arrest ]Number of patients in whom P25/30 were present and they had favourable neurologic outcomes [CPC scores 1 and 2]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881865
|Contact: Nikitas Nikitas, MD, PhDemail@example.com|
|University Hospitals Plymouth NHS Trust||Recruiting|
|Plymouth, Devon, United Kingdom, PL1 8DH|
|Contact: Christopher Rollinson, Dr 00441752431045 firstname.lastname@example.org|
|Study Director:||Chris Rollinson, Dr||University Hospitals Plymouth Department for Research Development and Innovation|