P25/30 SSEPs and Neurological Prognosis After Cardiac Arrest

NCT03881865 | Completed DMC

• 1 other identifier: 18/P/088
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

Study Title: Early recorded P25/30 somatosensory evoked potentials are associated with neurologic prognosis of comatose survivors after out of hospital cardiac arrest. Design: 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. Study Aims: 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. \[Validation of the prognostication significance of P25/30 Somatosensory Evoked Potentials in predicting neurologic outcome in comatose survivors post out of hospital cardiac arrest\]. Outcome Measures: 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. Population: Comatose survivors, after out of hospital cardiac arrest, treated in Derriford Hospital ICU, Penrose and Pencarrow wards. Eligibility: Adults \[\>18 years old\], out of hospital cardiac arrest, comatose after Return Of Spontaneous Circulation, admission to intensive care Estimated Duration:36 months

Conditions

Out-Of-Hospital Cardiac Arrest

Keywords

Somatosensory Evoked Potential; cardiac arrest; prognosis; P25/30

Outcome Measures

Primary Outcomes (1)

• Cerebral Performance Category [CPC] score

  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.

  up to 30 days after cardiac arrest

Secondary Outcomes (2)

• Mortality

  up to 30 days after cardiac arrest

• Correlation between P25/30 somatosensory evoked potentials presence and favourable prognosis

  Up to 30 days after cardiac arrest

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All adult \[\> 18 years old\] comatose survivors after non-trauma-related out of hospital cardiac arrest who are admitted to Derriford Hospital Intensive Care Unit.

You may qualify if:

• All adult comatose survivors after out of hospital cardiac arrest who are admitted to Derriford Hospital Intensive Care Unit \[Penrose and Pencarrow wards\]. The cause of cardiac arrest may be cardiac and/or non-cardiac or unknown at the time of enrolment.
• All patients must be comatose before intubation \[GCS equal or lower than 8\].
• All patients must be on one or more invasive organ support \[e.g. Endotracheal intubation and mechanical ventilation, vasopressor and/or inotropic support, Continuous Renal Replacement Therapy Sedated and/or on neuromuscular blocking agents\].
• All patients must be sedated before and during the time of SSEP recording. If clinically indicated, neuromuscular blocking agents may also be used.
• All patients must be on targeted temperature management as per Derriford ICU policy and protocol: For the first 24 hours after ICU admission, the target-temperature is 36°C with temperature control commencing within the first hour after critical care admission. For the next 48 hours the temperature of the patients will be maintained between 36-37°C. The aforementioned temperature targets are achieved with external cooling devices.

You may not qualify if:

• Non-comatose patients after ROSC
• Coma secondary to Intracranial and Intracerebral haemorrhage
• Patients with haemorrhagic shock
• Patients with severe neurologic disability \[CPC level higher than 2\] during the pre-cardiac arrest period
• Presence of active Demyelinating disease or past medical history of Demyelinating disease
• Trauma-related Cardiac arrest
• Previously or during the current admission diagnosed Spinal Cord and /or brain stem lesions
• Patients with Implantable defibrillator device \[incompatibility with SSEP recordings device\]

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

University Hospitals Plymouth NHS Trust

Plymouth, Devon, PL1 8DH, United Kingdom

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest; Heart Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Nikitas Nikitas, MD, PhD

  University Hospitals Plymouth Department for Research Development and Innovation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: March 20, 2019
• Study Start: October 8, 2018
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: May 6, 2023

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Attached to ClinicalTrials.gov record
• Access Criteria: ClinicalTrials.gov

Locations

GB (1)