Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL) as Early Biomarker for Renal Dysfunction and Good Neurologic Outcome in Out of Hospital Cardiac Arrest Patients

• Conditions: Post Cardiac Arrest Patient Who Was Treated by Hypothermia Protocol
• Interventions: Biological: Serum NGAL level

• Registration Number: NCT01987466
• Lead Sponsor: Yonsei University

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 available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2013-10
• Status Verified: 2013-11
• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-12
• Last Update Submitted: 2013-11-12
• Study First Posted: 2013-11-19
• Last Update Posted: 2013-11-19
• Primary Completion: 2015-10
• Study Completion: 2015-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 73

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Post cardiac arrest patient	Serum NGAL level	-

Primary Outcome Measures

Name	Time	Method
Predictive value of plasma NGAL for acute kidney injury and cerebral dysfunction following out of hospital cardiac arrest.	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.

Trial Locations

Locations (1)

Department of Emergency Medicine, Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of