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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01987466
Other study ID # 4-2013-0575
Secondary ID
Status Recruiting
Phase N/A
First received November 12, 2013
Last updated November 12, 2013
Start date October 2013
Est. completion date October 2015

Study information

Verified date November 2013
Source Yonsei University
Contact Yoo Seok Park, MD
Phone 82-2-2228-2460
Email pys0905@yuhs.ac
Is FDA regulated No
Health authority Korea: Institutional Review Board (Severance Hospital)
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 73
Est. completion date October 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


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

Locations

Country Name City State
Korea, Republic of Department of Emergency Medicine, Severance Hospital, Yonsei University Health System Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Predictive value of plasma NGAL for acute kidney injury and cerebral dysfunction following out of hospital cardiac arrest. 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 No