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

NCT01987466 | Unknown

• 1 other identifier: 4-2013-0575
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol

Keywords

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

Outcome Measures

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.

  Every 4 hour until 72 hour after resuscitation

Study Arms (1)

Post cardiac arrest patient

Biological: Serum NGAL level

Interventions

Serum NGAL level BIOLOGICAL

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

Post cardiac arrest patient

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 120-752, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 31441881 DERIVED

MeSH Terms

Conditions

Acute Kidney Injury; Heart Arrest; Hypothermia

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Diseases; Cardiovascular Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yoo Seok Park, MD

CONTACT

82-2-2228-2460; pys0905@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 19, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 19, 2013

Record last verified: 2013-11

Locations

KR (1)