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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

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ClinicalTrials.gov Identifier: NCT01987466
Recruitment Status : Unknown
Verified November 2013 by Yonsei University.
Recruitment status was:  Recruiting
First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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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.


Condition or disease Intervention/treatment
Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol Biological: Serum NGAL level

Study Design
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Study Type : Observational
Estimated Enrollment : 73 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : October 2013
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Post cardiac arrest patient Biological: Serum NGAL level
Investigators will check the plasma NGAL level after 4 hour from resuscitation. The plasma NGAL level is measured in ng/mg


Outcome Measures
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Primary Outcome Measures :
  1. Predictive value of plasma NGAL for acute kidney injury and cerebral dysfunction following out of hospital cardiac arrest. [ Time Frame: Every 4 hour until 72 hour after resuscitation ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01987466


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

Locations
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Korea, Republic of
Department of Emergency Medicine, Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Yoo Seok Park, MD    82-2-2228-2460    pys0905@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01987466    
Other Study ID Numbers: 4-2013-0575
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013
Keywords provided by Yonsei University:
Neutrophil Gelatinase-associated Lipocalin(NGAL)
Acute renal failure
Cardiac arrest
Hypothermia
Additional relevant MeSH terms:
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Heart Arrest
Hypothermia
Heart Diseases
Cardiovascular Diseases
Body Temperature Changes