Clinical trial NCT01987466: Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL) as Early Biomarker for Renal Dysfunction and Good Neurologic Outcome in Out of Hospital Cardiac Arrest Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol
Keywords: Neutrophil Gelatinase-associated Lipocalin(NGAL)
Acute renal failure
Cardiac arrest
Hypothermia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 73
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Predictive value of plasma NGAL for acute kidney injury and cerebral dysfunction following out of hospital cardiac arrest.
timeFrame: Every 4 hour until 72 hour after resuscitation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Emergency Medicine, Severance Hospital, Yonsei University Health System
Study officials:
References:
citation: 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.