NCT03615300

Brief Summary

This study was performed to determine the prognosis of patients after cardiac arrest using serum markers called NGAL. The initial NGAL values of patients with post-cardiac arrest syndrome are checked by blood tests, and the long-term neurological prognosis and survival rate are collected after 6 months.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
73

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 30, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2022

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

3.8 years

First QC Date

July 30, 2018

Last Update Submit

May 9, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Long term neurologic outcome

    Patients' CPC score after 6 months (good outcome : CPC score 1, 2 / poor outcome : CPC score 3, 4, 5)

    6 months

Secondary Outcomes (1)

  • Proportion of participants with Overall Survival at 6 months

    6 months

Study Arms (2)

good neurologic outcome

Patients with good neurological prognosis after 6 months (CPC 1, 2). serum NGAL is collected.

Diagnostic Test: serum NGAL

poor neurologic outcome

Patients with poor neurological prognosis after 6 months (CPC 3, 4, 5). serum NGAL is collected.

Diagnostic Test: serum NGAL

Interventions

serum NGALDIAGNOSTIC_TEST

serum NGAL was measured at 0, 24, 48, and 72 hours after recovery of spontaneous circulation.

good neurologic outcomepoor neurologic outcome

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult survivors after out-of-hopital cardiac arrest who underwent targeted temperature management and survived longer than 3 days.

You may qualify if:

  • Adult patients who underwent targeted temperature management after out-of-hospital cardiac arrest.

You may not qualify if:

  • Patients who did not survived 3 days after cardiac arrest.
  • Pre-existing end-stage renal disease or dependence on renal replacement therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uijeongbu St. Mary's Hospital

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

Location

Related Publications (2)

  • Elmer J, Jeong K, Abebe KZ, Guyette FX, Murugan R, Callaway CW, Rittenberger JC; Pittsburgh Post-Cardiac Arrest Service. Serum Neutrophil Gelatinase-Associated Lipocalin Predicts Survival After Resuscitation From Cardiac Arrest. Crit Care Med. 2016 Jan;44(1):111-9. doi: 10.1097/CCM.0000000000001357.

    PMID: 26457752BACKGROUND
  • Park YR, Oh JS, Jeong H, Park J, Oh YM, Choi S, Choi KH. Predicting long-term outcomes after cardiac arrest by using serum neutrophil gelatinase-associated lipocalin. Am J Emerg Med. 2018 Apr;36(4):660-664. doi: 10.1016/j.ajem.2017.12.013. Epub 2017 Dec 7.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Officials

  • Joo Suk Oh, MD PhD

    The Catholic University of Korea, Uijeongbu ST. Mary's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 30, 2018

First Posted

August 3, 2018

Study Start

June 28, 2018

Primary Completion

May 1, 2022

Study Completion

May 1, 2022

Last Updated

May 13, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations