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
CRIS Registration Number |
KCT0003544 |
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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
Board Approval Status | Submitted approval |
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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 Person for Principal Investigator / Scientific Queries | |
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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
Study Site | Multi-center Number of center : 6 | |
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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
1. Source of Monetary/Material Support | |
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Organization Name | National Research Foundation |
Organization Type | Government |
Project ID | 2018R1C1B5082969 |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Chung-Ang Univerisity Hospital |
Organization Type | Medical Institute |
7. Study Summary
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. |
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8. Study Design
Study Type | Observational Study |
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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. |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
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. |
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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. |
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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)
Type of Primary Outcome | Not applicable | |
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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 |
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Timepoint | During admission |
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Secondary Outcome(s) 1 | ||
Outcome | Arrest location (home, workplace, sports or recreating, street or highway, public building, nursing home, and educational institution) |
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Timepoint | During admission |
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Secondary Outcome(s) 2 | ||
Outcome | Bystander cardiopulmonary resuscitation (yes or no) |
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Timepoint | During admission |
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Secondary Outcome(s) 3 | ||
Outcome | First monitored rhythm (ventricular fibrillation, pulseless ventricular tachycardia, pulseless electrical activity, and asystole) |
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Timepoint | During admission |
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Secondary Outcome(s) 4 | ||
Outcome | The date of expiration if patients expire at 30th day since return of spontaneous circulation |
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Timepoint | At the time of 30th day since return of spontaneous circulation |
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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) |
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Timepoint | During admission |
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Secondary Outcome(s) 6 | ||
Outcome | Renal replacement therapy (yes or no) |
|
Timepoint | During admission |
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Secondary Outcome(s) 7 | ||
Outcome | The type of renal replacement therapy (continuous renal replacement therapy or hemodialysis) |
|
Timepoint | During admission |
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Secondary Outcome(s) 8 | ||
Outcome | Date of renal replacement therapy (initiation, termination, and duration) |
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Timepoint | During admission |
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Secondary Outcome(s) 9 | ||
Outcome | Discharge date |
|
Timepoint | At the time of discharge |
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Secondary Outcome(s) 10 | ||
Outcome | Age (years) |
|
Timepoint | During admission |
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Secondary Outcome(s) 11 | ||
Outcome | Sex (male or female) |
|
Timepoint | During admission |
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Secondary Outcome(s) 12 | ||
Outcome | Weight (kg) |
|
Timepoint | During admission |
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Secondary Outcome(s) 13 | ||
Outcome | Past medical history (hypertension, diabetes mellitus, heart failure, chronic kidney disease) |
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Timepoint | During admission |
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Secondary Outcome(s) 14 | ||
Outcome | Witnessed arrest (witnessed or not witnessed) |
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Timepoint | During admission |
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Secondary Outcome(s) 15 | ||
Outcome | Pathogenesis (medical, trauma, drug overdose, drowning, electrocution, and asphyxia) |
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Timepoint | During admission |
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Secondary Outcome(s) 16 | ||
Outcome | Response time (time interval from call to visit) |
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Timepoint | During admission |
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Secondary Outcome(s) 17 | ||
Outcome | Defibrillation time (time interval from call to the time the first shock) |
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Timepoint | During admission |
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Secondary Outcome(s) 18 | ||
Outcome | Epinephrine dose (mg) |
|
Timepoint | During admission |
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Secondary Outcome(s) 19 | ||
Outcome | Coronary angiography (yes or no) |
|
Timepoint | During admission |
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Secondary Outcome(s) 20 | ||
Outcome | Extracorporeal membrane oxygenation (yes or no) |
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Timepoint | During admission |
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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 |
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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 |
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Secondary Outcome(s) 25 | ||
Outcome | Survival discharge (yes or no) |
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Timepoint | At the time of discharge |
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Secondary Outcome(s) 26 | ||
Outcome | Modified Rankin scale at discharge |
|
Timepoint | At the time of discharge |
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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
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | Yes |
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Time of Sharing | 2022. 8 |
Way of Sharing | Available on Request
(jehyeokoh@cau.ac.kr) |
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