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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

Tracking Information
First Submitted Date November 12, 2013
First Posted Date November 19, 2013
Last Update Posted Date November 19, 2013
Study Start Date October 2013
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 12, 2013)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL) as Early Biomarker for Renal Dysfunction and Good Neurologic Outcome in Out of Hospital Cardiac Arrest Patients
Official Title Not Provided
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol
Intervention 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
Study Groups/Cohorts Post cardiac arrest patient
Intervention: Biological: Serum NGAL level
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: November 12, 2013)
73
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2015
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT01987466
Other Study ID Numbers 4-2013-0575
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Yonsei University
Study Sponsor Yonsei University
Collaborators Not Provided
Investigators Not Provided
PRS Account Yonsei University
Verification Date November 2013