NCT03175965

Brief Summary

This study aims to examine whether P30 wave of somatosensory evoked potentials (SEP) is related with outcome after cardiac arrest. The study design is a prospective, multicenter-observational study. Patients survived after out-of-hospital cardiac arrest undergoing hypothermic-targeted temperature management will participate in the study. Relationship of P30 wave of SEP with the neurologic outcome on hospital discharge will be evaluated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2017

Completed
26 days until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

May 14, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

May 31, 2017

Last Update Submit

May 11, 2019

Conditions

Keywords

Heart arrest, hypothermia, SEP, prognosis

Outcome Measures

Primary Outcomes (1)

  • Association of abscence of P30 with poor outcome without under the influence of hypothermia and sedation

    SEP under the normothermic-TTM without sedation

    72 hours after ROSC

Secondary Outcomes (3)

  • Association of abscence of P30 with poor outcome under the influence of hypothermia and sedation

    24 hours after ROSC

  • Association of N20 with high amplitude with poor outcome without under the influence of hypothermia and sedation

    72 hours after ROSC

  • Association of N20 with high amplitude with poor outcome under the influence of hypothermia and sedation

    24 hours after ROSC

Interventions

Somatosensory evoked potential on 24, 72 hours after cardiac arrest.

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Out-of-hospital cardiac arrest patients undergoing hypothermic-targeted temperature management in the four academically affiliated tertiary care centers .

You may qualify if:

  • Comatose survivors after out-of-hospital cardiac arrest

You may not qualify if:

  • Not treated by hypothermic-targeted temperature management

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Bucheon St. Mary's Hospital

Bucheon-si, Gyeonggi-do, 14647, South Korea

Location

Uijeongbu St. Mary's Hospital

Uijeongbu-si, Gyeonggi-do, 11765, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 06591, South Korea

Location

Yeouido St. Mary's Hospital

Seoul, 07345, South Korea

Location

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestHeart ArrestHypothermia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Joo Suk Oh, MD

    Uijeongbu St. Mary's Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 31, 2017

First Posted

June 5, 2017

Study Start

July 1, 2017

Primary Completion

November 30, 2018

Study Completion

November 30, 2018

Last Updated

May 14, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations