Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL) as Early Biomarker for Renal Dysfunction and Good Neurologic Outcome in Out of Hospital Cardiac Arrest Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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 Type :||Observational|
|Estimated Enrollment :||73 participants|
|Study Start Date :||October 2013|
|Estimated Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||October 2015|
|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
- 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.
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
|Contact: Yoo Seok Park, MDemail@example.com|
|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 firstname.lastname@example.org|