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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Study Start Date : | October 2013 |
Estimated Primary Completion Date : | October 2015 |
Estimated Study Completion Date : | October 2015 |

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 |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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, MD | 82-2-2228-2460 | pys0905@yuhs.ac |
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 |
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 |
Neutrophil Gelatinase-associated Lipocalin(NGAL) Acute renal failure Cardiac arrest Hypothermia |
Heart Arrest Hypothermia Heart Diseases Cardiovascular Diseases Body Temperature Changes |