Effect of Propofol on Cardioprotective Role of Remote Isc... | NCT02932722

Studies
Effect of Propofol on Cardioprotective Role of Remote Ischemic Preconditioning (RIPC)

NCT02932722

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Feb 20, 2018Actual

Enrollment

51Actual

Phase

Not Applicable

Conditions

Myocardial Infarction

Interventions

Control
Propofol
Sevoflurane

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1605-079-761	Other Identifier	Seoul National University Hospital IRB

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2017Actual

Primary Completion Date

Feb 7, 2018Actual

Completion Date

Feb 7, 2018Actual

First Submitted Date

Sep 26, 2016

First Submission Date that Met QC Criteria

Oct 12, 2016

First Posted Date

Oct 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2018

Last Update Posted Date

Feb 20, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yunseok Jeon, Principal Investigator, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study involves research using human subjects (cardiac surgical patients) to evaluate the effect of remote ischemic preconditioning (RIPC) on cardioprotective outcomes. RIPC applied to upper or lower extremities has been shown cardioprotective role by lowering release of cardiac troponin in patients with cardiac diseases. However, it is not clear whether anesthetics, such as propofol or sevoflurane, may impair the cardioprotective effect of RIPC in cardiac surgical patients. Therefore, the purpose of the study is to compare the effects of anesthetics on cardioprotection of RIPC in patients undergoing cardiac surgery.

Detailed Description

Patients undergoing cardiac surgery using cardiopulmonary bypass will be randomized to control, propofol, or sevoflurane group. Patients in the control group will receive remote ischemic preconditioning (RIPC) on their upper arms before anesthetic induction. Patients in the propofol or sevoflurane groups will receive RIPC after anesthetic induction using propofol or sevoflurane, respectively. In all patients, arterial blood samples will be obtained before and after each RIPC. From the samples, human dialysate will be obtained and perfused to rat heart through Langendorff apparatus before ischemia-reperfusion injury to the rat heart. Infarct size of the sectioned rat heart will be compared among the three - control, propofol, and sevoflurane - groups.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control	Sham Comparator	Patients in the control group will be receive remote ischemic preconditioning before anesthetic induction (before exposure to any anesthetic).	Other: Control
Propofol	Active Comparator	Patients in the propofol groups will be receive remote ischemic preconditioning after anesthetic induction using propofol, as a main anesthetic.	Drug: Propofol
Sevoflurane	Active Comparator	Patients in the sevoflurane groups will be receive remote ischemic preconditioning after anesthetic induction using sevoflurane, as a main anesthetic.	Drug: Sevoflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Control	Other	Patients in the control groups do not receive any anesthetic during remote ischemic preconditioning.	Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Infarct size of the rat heart		1 day after ischemia-reperfusion injury

Secondary Outcomes

Measure	Description	Time Frame
Cardiac troponin I after surgery		72 hours postoperatively
Major adverse cardiovascular and cerebrovascular events		Through study completion, average of 2 weeks before hospital discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA class I~III patients undergoing cardiac surgery using cardiopulmonary bypass

Exclusion Criteria:

Cardiac surgery without using cardiopulmonary bypass
Descending thoracic aortic surgery
Strenuous exercise, excessive alcohol or caffeine intake 24 hours before remote ischemic preconditioning
Left ventricular ejection fraction < 30%
Uncontrolled hypertension or diabetes mellitus
Severe renal or hepatic dysfunction
Patients on hemodialysis
Patients with arterio-venous fistula on arms or any reason to protect arms
Peripheral vascular or nerve disease, bleeding tendency
Preoperative use of IABP, ECMO, or ventricular assist devices
Emergency operation, redo operation
Refuse to enroll
Pregnancy
Preoperative use of beta-blockers

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yunseok Jeon, MD, PhD	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital		Seoul		03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D015742	Propofol
D000077149	Sevoflurane

Ancestor Terms

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided