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

NCT ID: NCT01987466

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Post cardiac arrest patient

Serum NGAL level

Intervention Type BIOLOGICAL

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

Interventions

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Serum NGAL level

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

* 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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Emergency Medicine, Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yoo Seok Park, MD

Role: CONTACT

Phone: 82-2-2228-2460

Email: [email protected]

Facility Contacts

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Yoo Seok Park, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31441881 (View on PubMed)

Other Identifiers

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4-2013-0575

Identifier Type: -

Identifier Source: org_study_id