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Prospective multi-center observational study to determine the natural course of acute kidney injury according to the injury stage in adult out-of-hospital cardiac arrest patients treated with targeted temperature management

Status Approved

  • First Submitted Date

    2018/12/18

  • Registered Date

    2019/02/21

  • Last Updated Date

    2020/09/16

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0003544
    Unique Protocol ID 1803-014-348
    Public/Brief Title Observational study for the natural course of acute kidney injury after out-of-hospital cardiac arrest
    Scientific Title Prospective multi-center observational study to determine the natural course of acute kidney injury according to the injury stage in adult out-of-hospital cardiac arrest patients treated with targeted temperature management
    Acronym PCAS-AKI-PRO
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 1803-014-348
    Approval Date 2018-12-17
    Institutional Review Board Name Chung-Ang University Hospital Institutional Review Board
    Institutional Review Board Address 102 Heukseok-ro, Dongjak-gu, Seoul, Republic of Korea
    Institutional Review Board Telephone 02-6299-2738
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Je Hyeok Oh
    Title Assistant Professor
    Telephone +82-2-6299-1820
    Affiliation Chung-Ang Univerisity Hospital
    Address 102 Heukseok-ro, Dongjak-gu, Seoul, Republic of Korea
    Contact Person for Public Queries
    Name Je Hyeok Oh
    Title Assistant Professor
    Telephone +82-2-6299-1820
    Affiliation Chung-Ang Univerisity Hospital
    Address 102 Heukseok-ro, Dongjak-gu, Seoul, Republic of Korea
    Contact Person for Updating Information
    Name Je Hyeok Oh
    Title Assistant Professor
    Telephone +82-2-6299-1820
    Affiliation Chung-Ang Univerisity Hospital
    Address 102 Heukseok-ro, Dongjak-gu, Seoul, Republic of Korea
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Multi-center Number of center : 6
    Overall Recruitment Status Completed
    Date of First Enrollment 2019-03-18 Actual
    Target Number of Participant 238
    Primary Completion Date 2020-08-22 , Actual
    Study Completion Date 2020-08-22 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Completed
    Date of First Enrollment 2019-03-18 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Yonsei University Health System, Gangnam Severance Hospital
    Recruitment Status Terminated Terminated Reason : 해당기관의 책임연구자가 연구에서 빠지기로 결정함
    Date of First Enrollment 2019-03-21 ,
    Recruitment Status by Participating Study Site 3
    Name of Study Yonsei University, Wonju Severance Christian Hospital
    Recruitment Status Completed
    Date of First Enrollment 2019-04-08 ,
    Recruitment Status by Participating Study Site 4
    Name of Study Ewha Womans University Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2019-09-06 ,
    Recruitment Status by Participating Study Site 5
    Name of Study HANIL General Hospital
    Recruitment Status Completed
    Date of First Enrollment 2019-05-08 ,
    Recruitment Status by Participating Study Site 6
    Name of Study Chung-Ang Univerisity Hospital
    Recruitment Status Completed
    Date of First Enrollment 2019-04-15 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name National Research Foundation
    Organization Type Government
    Project ID 2018R1C1B5082969
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Chung-Ang Univerisity Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Sudden cardiac arrest (SCA) is a disease can cause serious outcomes. In South Korea, the incidence of SCA was 41.5 (per 100,000 people) in 2016. Among them, only 7.6% was survived and neurologically intact survival was 4.2%. The high mortality rate is caused by a unique pathophysiological process involving multi-organ system. Initially, global ischemia during cardiac arrest causes direct organ injuries. However, additional damage develops during and after reperfusion. This process is called as post-cardiac arrest syndrome (PCAS) comprises post-cardiac arrest brain injury, post-cardiac arrest myocardial dysfunction, systemic ischemia/reperfusion response, and persistent precipitation pathology. Although the course and prognosis of brain and myocardial injuries of PCAS are well known, acute kidney injury (AKI) had not been studied well because lack of unified diagnostic criteria. However, after developing an unified definition for diagnosing AKI had been developed by the Kidney Disease: Improving Global Outcomes (KDIGO) AKI Guideline Work Group in 2012, several single center cohort studies including large number of out-of-hospital cardiac arrest (OHCA) patients had been reported recently. As a results, it had been verified that the development of AKI was associated with mortality of the OHCA patients and with poor neurological outcome. If we know the natural course and prognosis of AKI after OHCA, we could decide whether and when we will start the intensive treatment for the AKI such as renal replacement therapy (RRT). We could not predict the natural course, recovery rate, and prognosis of AKI according to the stages of AKI, because most of the AKI after OHCA was stage 1 (52%) or 2 (25%) in the previous study.
    This study is prepared to observe the natural course of AKI after OHCA including when to develop and when to recover, and to confirm whether the survivals and neurological outcomes were different according to the stages of AKI or not.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Cohort
    Time Perspective Prospective  
    Target Number of Participant 238
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Targeted temperature management group after out-of-hospital cardiac arrest

    Cohort/Group Description

    We observe the natural course including development and recovery of the acute kidney injury and outcomes including survival rate and neurological status in all adult patients (≥19 years) with out-of-hospital cardiac arrest irrespective of the cause of arrest who are unconscious after return of spontaneous circulation (Glasgow Coma Scale score <8) and treated with targeted temperature management.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    All adult patients (≥19 years) with out-of-hospital cardiac arrest irrespective of the cause of arrest who are unconscious after return of spontaneous circulation (Glasgow Coma Scale score <8) and treated with targeted temperature management in the 6 research institutions.
    Sampling Method
    Non-probablity sampling: All adults patients visit  to the 6 research institutions are screened on whether they are fit to the inclusion criteria or not.
    Condition(s)/Problem(s) * (S00-T98)Injury, poisoning and certain other consequences of external causes 
       (S37.00)Injury of kidney without open wound into cavity 

    Acute kidney injury after out-of-hospital cardiac arrest
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~No Limit

    Description

    All adult patients (≥19 years) with out-of-hospital cardiac arrest irrespective of the cause of arrest who are unconscious after return of spontaneous circulation (Glasgow Coma Scale score <8) and treated with targeted temperature management.
    Exclusion Criteria
    (1) Patients’ age<19 years
    (2) Patients who are dead on arrival to the hospital and do not receive cardiopulmonary resuscitation (CPR)
    (3) Patients who do not achieve return of spontaneous circulation (ROSC) in spite of CPR
    (4) Patients who do not receive targeted temperature management in spite of achieving ROSC
    (5) Patients who were diagnosed as end-stage renal disease with dialysis (peritoneal dialysis or hemodialysis) before developing cardiac arrest
    (6) Patients who have Do-Not-Attempt-Resuscitation order
    (7) Patients who have acute intracranial hemorrhage or acute ischemic stroke
    (8) Patients who have active bleeding
    (9) Patients’ legal surrogates refuse to participate the study or withdrawal of informed consent during the study period by patients’ legal surrogates or patients’ themselves
    (10) Patients’ legal surrogates cannot speak Korean.
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Not applicable
    Primary Outcome(s) 1
    Outcome
    The date of acute kidney injury development and recovery which is calculated since the day of achieving return of spontaneous circulation
    Timepoint
    During admission
    Secondary Outcome(s) 1
    Outcome
    Arrest location (home, workplace, sports or recreating, street or highway, public building, nursing home, and educational institution)
    Timepoint
    During admission
    Secondary Outcome(s) 2
    Outcome
    Bystander cardiopulmonary resuscitation (yes or no)
    Timepoint
    During admission
    Secondary Outcome(s) 3
    Outcome
    First monitored rhythm (ventricular fibrillation, pulseless ventricular tachycardia, pulseless electrical activity, and asystole)
    Timepoint
    During admission
    Secondary Outcome(s) 4
    Outcome
    The date of expiration if patients expire at 30th day since return of spontaneous circulation
    Timepoint
    At the time of 30th day since return of spontaneous circulation
    Secondary Outcome(s) 5
    Outcome
    Daily serum creatinine level (mg/dL, if the serum creatinine level will be checked two or more times in a day, highest value will be recorded)
    Timepoint
    During admission
    Secondary Outcome(s) 6
    Outcome
    Renal replacement therapy (yes or no)
    Timepoint
    During admission
    Secondary Outcome(s) 7
    Outcome
    The type of renal replacement therapy (continuous renal replacement therapy or hemodialysis)
    Timepoint
    During admission
    Secondary Outcome(s) 8
    Outcome
    Date of renal replacement therapy (initiation, termination, and duration)
    Timepoint
    During admission
    Secondary Outcome(s) 9
    Outcome
    Discharge date
    Timepoint
    At the time of discharge
    Secondary Outcome(s) 10
    Outcome
    Age (years)
    Timepoint
    During admission
    Secondary Outcome(s) 11
    Outcome
    Sex (male or female)
    Timepoint
    During admission
    Secondary Outcome(s) 12
    Outcome
    Weight (kg)
    Timepoint
    During admission
    Secondary Outcome(s) 13
    Outcome
    Past medical history (hypertension, diabetes mellitus, heart failure, chronic kidney disease)
    Timepoint
    During admission
    Secondary Outcome(s) 14
    Outcome
    Witnessed arrest (witnessed or not witnessed)
    Timepoint
    During admission
    Secondary Outcome(s) 15
    Outcome
    Pathogenesis (medical, trauma, drug overdose, drowning, electrocution, and asphyxia)
    Timepoint
    During admission
    Secondary Outcome(s) 16
    Outcome
    Response time (time interval from call to visit)
    Timepoint
    During admission
    Secondary Outcome(s) 17
    Outcome
    Defibrillation time (time interval from call to the time the first shock)
    Timepoint
    During admission
    Secondary Outcome(s) 18
    Outcome
    Epinephrine dose (mg)
    Timepoint
    During admission
    Secondary Outcome(s) 19
    Outcome
    Coronary angiography (yes or no)
    Timepoint
    During admission
    Secondary Outcome(s) 20
    Outcome
    Extracorporeal membrane oxygenation (yes or no)
    Timepoint
    During admission
    Secondary Outcome(s) 21
    Outcome
    Targeted temperature of TTM (33°C or 36°C)
    Timepoint
    During admission
    Secondary Outcome(s) 22
    Outcome
    Maintenance period of targeted temperature management (24 h or 48 h)
    Timepoint
    During admission
    Secondary Outcome(s) 23
    Outcome
    Urine output (mL/kg/h) in intensive care unit (ICU)
    Timepoint
    During admission
    Secondary Outcome(s) 24
    Outcome
    Event of shock (mean arterial pressure < 70 mmHg) after return of spontaneous circulation
    Timepoint
    During admission
    Secondary Outcome(s) 25
    Outcome
    Survival discharge (yes or no)
    Timepoint
    At the time of discharge
    Secondary Outcome(s) 26
    Outcome
    Modified Rankin scale at discharge
    Timepoint
    At the time of discharge
    Secondary Outcome(s) 27
    Outcome
    Modified Rankin scale at 30th day since return of spontaneous circulation
    Timepoint
    At the time of 30th day since return of spontaneous circulation
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement Yes
    Time of Sharing 2022. 8
    Way of Sharing Available on Request
    (jehyeokoh@cau.ac.kr)
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