NCT02932722

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

February 22, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2018

Completed
Last Updated

February 20, 2018

Status Verified

February 1, 2018

Enrollment Period

12 months

First QC Date

September 26, 2016

Last Update Submit

February 19, 2018

Conditions

Myocardial Infarction

Keywords

PropofolSevofluranePreconditioning

Outcome Measures

Primary Outcomes (1)

  • Infarct size of the rat heart

    1 day after ischemia-reperfusion injury

Secondary Outcomes (2)

  • Cardiac troponin I after surgery

    72 hours postoperatively

  • Major adverse cardiovascular and cerebrovascular events

    Through study completion, average of 2 weeks before hospital discharge

Study Arms (3)

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

ControlOTHER

Patients in the control groups do not receive any anesthetic during remote ischemic preconditioning.

Also known as: Not receiving any anesthetic
Control
PropofolDRUG

Patients in the propofol group receive propofol anesthesia during remote ischemic preconditioning.

Also known as: Receiving propofol anesthesia
Propofol
SevofluraneDRUG

Patients in the sevoflurane group receive sevoflurane anesthesia during remote ischemic preconditioning.

Also known as: Receiving sevoflurane anesthesia
Sevoflurane

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Yunseok Jeon, MD, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 26, 2016

First Posted

October 13, 2016

Study Start

February 22, 2017

Primary Completion

February 7, 2018

Study Completion

February 7, 2018

Last Updated

February 20, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)