Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

P25/30 SSEPs and Neurological Prognosis After Cardiac Arrest

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881865
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Plymouth NHS Trust

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


Condition or disease
Out-Of-Hospital Cardiac Arrest

Show Show detailed description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 190 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mortality [ Time Frame: up to 30 days after cardiac arrest ]
    Number of patients that died during the study period

  2. 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]



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  1. 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.
  2. All patients must be comatose before intubation [GCS equal or lower than 8].
  3. 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].
  4. All patients must be sedated before and during the time of SSEP recording. If clinically indicated, neuromuscular blocking agents may also be used.
  5. 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.
  6. Patients must have a CT scan of the head if severe cerebral pathology which is part of the exclusion criteria is clinically suspected.
  7. Absence of all exclusion criteria

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Nikitas Nikitas, MD, PhD 00447741665616 nikitas.nikitas@nhs.net

Locations
Layout table for location information
United Kingdom
University Hospitals Plymouth NHS Trust Recruiting
Plymouth, Devon, United Kingdom, PL1 8DH
Contact: Christopher Rollinson, Dr    00441752431045    crollinson@nhs.net   
Sponsors and Collaborators
University Hospital Plymouth NHS Trust
Investigators
Layout table for investigator information
Study Director: Chris Rollinson, Dr University Hospitals Plymouth Department for Research Development and Innovation
Layout table for additonal information
Responsible Party: University Hospital Plymouth NHS Trust
ClinicalTrials.gov Identifier: NCT03881865    
Other Study ID Numbers: 18/P/088
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Plymouth NHS Trust:
Somatosensory Evoked Potential
cardiac arrest
prognosis
P25/30
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases