Predicting Long-term Outcomes After Cardiac Arrest by Using Serum NGAL

Predicting Long-term Outcomes After Cardiac Arrest by Using Serum NGAL: A Prospective, Observational Study

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.

Study Overview

• Status: Terminated
• Conditions: Out-of-Hospital Cardiac Arrest
• Intervention / Treatment: Diagnostic test: serum NGAL

Detailed Description

Serum NGAL is currently being used as a test to determine the likelihood of developing renal failure. However, in a previous study, serum NGAL correlated with neurological prognosis in post cardiac arrest syndrome patients. This prospective study attempts to see the role of serum NGAL as a prognostic factor by including a sufficient number of patients.

• Study Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Uijeongbu-si, Gyeonggi-do, Korea, Republic of, 11765
      • Uijeongbu St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
good neurologic outcome; Patients with good neurological prognosis after 6 months (CPC 1, 2). serum NGAL is collected.	Diagnostic test: serum NGAL; serum NGAL was measured at 0, 24, 48, and 72 hours after recovery of spontaneous circulation.
poor neurologic outcome; Patients with poor neurological prognosis after 6 months (CPC 3, 4, 5). serum NGAL is collected.	Diagnostic test: serum NGAL; serum NGAL was measured at 0, 24, 48, and 72 hours after recovery of spontaneous circulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with Overall Survival at 6 months	6-month survival rate of patients'	6 months

Collaborators and Investigators

• Sponsor: Uijeongbu St. Mary Hospital
• Investigators: Principal Investigator: Joo Suk Oh, MD PhD, The Catholic University of Korea, Uijeongbu St. Mary's Hospital

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2018
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: July 30, 2018
• First Submitted That Met QC Criteria: August 2, 2018
• First Posted (Actual): August 3, 2018

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 9, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest
• Other Study ID Numbers: UC18OESI0055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No