- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01987466
Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL) as Early Biomarker for Renal Dysfunction and Good Neurologic Outcome in Out of Hospital Cardiac Arrest Patients
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Yoo Seok Park, MD
- Phone Number: 82-2-2228-2460
- Email: pys0905@yuhs.ac
Study Locations
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-
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Seoul, Korea, Republic of, 120-752
- Recruiting
- Department of Emergency Medicine, Severance Hospital, Yonsei University Health System
-
Contact:
- Yoo Seok Park, MD
- Phone Number: 82-2-2228-2460
- Email: pys0905@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Post cardiac arrest patient
|
Investigators will check the plasma NGAL level after 4 hour from resuscitation.
The plasma NGAL level is measured in ng/mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
Every 4 hour until 72 hour after resuscitation
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2013-0575
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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