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Status unknownNCT01987466Updated Nov 19, 2013

Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL) as Early Biomarker for Renal Dysfunction and Good Neurologic Outcome in Out of Hospital Cardiac Arrest Patients

An observational study in Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol, sponsored by Yonsei University. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2013-11-19.

Sponsored by Yonsei University · Observational

The sponsor has not verified this record recently (last verified Nov 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
73
Ages
19 Years and older
Sex
All
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Study summary

Postresuscitation disease is a constellation of disorders related to whole-body ischemia and reperfusion syndrome. It includes hypoxic damage in brain, liver, kidney, heart and other organ. In previous study more than one-third of patients resuscitation from out of hospital cardiac arrest developed renal dysfunction. In acute kidney injury, NGAL is an earlier marker compared with serum creatinine.

Cardiac arrest and severe asphyxia result in global brain ischemia. In previous study serum NGAL correlated with hypoxic ischemic encephalopathy in asphyxiated neonate.

This study was designed to assess serum NGAL level in postresuscitative patients to evaluate its relation to hypoxic brain injury severity, and its clinical utility for early detection of acute kidney injury in these patients.

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Conditions studied

  • Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol

Keywords

  • Neutrophil Gelatinase-associated Lipocalin(NGAL)
  • Acute renal failure
  • Cardiac arrest
  • Hypothermia
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In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 73 is below the median of 200 across 383 observational studies indexed under Heart Arrest.

Browse Heart Arrest studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients over 19 years of age admitted to our hospital after succesful resuscitation from out of hospital cardiac arrest. Mental state of the patient is less than 8 in GCS scale and the patient should be undergoing therapeutic hypothermia.Exclusion criteria is age younger than 19 years, terminal illness or do-not resuscitation status, pre-existing coma, abnormal mental status with defined intracranial lesion (ex. cerebral hemorrhage, cerebral infarction, etc), unstable vital sign and previous end-stage renal disease.

Inclusion criteria

  • 19 years and older
  • Successful resuscitation from out of hospital cardiac arrest and spontaneous circulation time is longer than 20 min.
  • GCS \< 8

Exclusion criteria

Exclusion Criteria:

  • Pre-existing coma before cardiac arrest
  • Mental change with other cause except cardiac arrest.(Ex. traumatic brain injury, cerebro-vascular accident.)
  • Unstable vital sign (Systolic blood pressure is lower than 60mmHg)
  • History of terminal illness.
  • Coagulation deficiency.
  • Pregnancy state or younger than 18 year
  • Pre-existing end-stage renal disease or dependence on renal replacement therapy
  • Transfer to other hospital and cannot know prognosis
  • Withdrawal of care due to family wishes
  • The patient arrives our hospital after 4 hours or longer from resuscitation.
  • The patient refuses to sign the consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
73 participants (estimated)
Patient registry
No

Groups and cohorts

  • Post cardiac arrest patient

    Biological: Serum NGAL level

Interventions

  • BiologicalSerum NGAL level

    Investigators will check the plasma NGAL level after 4 hour from resuscitation. The plasma NGAL level is measured in ng/mg

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What researchers measure

Primary outcomes

  1. Predictive value of plasma NGAL for acute kidney injury and cerebral dysfunction following out of hospital cardiac arrest.

    All patients in this study will be treated by induced hypothermia protocol in our hospital. Plasma NGAL level will check after 4hour from resuscitation. Renal dysfunction is defined using the RIFLE criteria. Patient base line creatinine is defined the first laboratory values obtained in the emergency department. The maximum difference between the peak creatinine level during the first 72hour of hospitalization and the base line creatinine level was determined for every patients. Cerebral dysfunction is defined using CPC scale. Neurologic exam will be performed on arrival, 24, 48,72 hours after resuscitation and discharge day. Good neurologic outcome is defined as CPC of 1 or 2. The diagnostic accuracy of NGAL in predicting acute kidney injury and neurologic outcome will be evaluated.

    Time frame: Every 4 hour until 72 hour after resuscitation

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Study locations

1 of 1 sites recruiting
  • Department of Emergency Medicine, Severance Hospital, Yonsei University Health System
    Seoul, 120-752, Korea, Republic of
    Recruiting
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References and documents

Publications

  • Lee JH, Park I, You JS, Kim MJ, Lee HS, Park YS, Park HC, Chung SP. Predictive performance of plasma neutrophil gelatinase-associated lipocalin for neurologic outcomes in out-of-hospital cardiac arrest patients treated with targeted temperature management: A prospective observational study. Medicine (Baltimore). 2019 Aug;98(34):e16930. doi: 10.1097/MD.0000000000016930. PubMed 31441881 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01987466
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Nov 19, 2013
Start date
Oct 2013
Primary completion
Oct 2015 (estimated)
Completion
Oct 2015 (estimated)
Last update
Nov 19, 2013

Study contacts

Yoo Seok Park, MD
Contact
pys0905@yuhs.ac
82-2-2228-2460

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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