NCT02136979

Brief Summary

CD39 and CD73 was known protein expressed on surface of Th1 and Th17 cell and modulate immune related reaction. Cardiopulmonary bypass (CPB) can induce inflammatory reaction during cardiac surgery, and induce immunosuppression. Propofol and volatile anesthetics were related to immune reaction. However, the effect of propofol and sevoflurane on the change of CD39 and CD73 after CPB was not evaluated in previous studies. The authors hypothesized that the expression of CD39 and CD73 would differ between propofol- and volatile anaesthetic-based anaesthesia in patients undergoing CPB. Therefore, the present study determined the effect of propofol and sevoflurane on CD39 and CD73 during and after CPB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2014

Typical duration for phase_4

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

May 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

May 21, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

2.6 years

First QC Date

May 7, 2014

Last Update Submit

January 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The level of CD39 and CD73 between propofol and sevoflurane group after CPB

    The difference of CD39 and CD73 level between propofol and sevoflurane group

    from preoperative status up to 48 hrs after CPB weaning status

Study Arms (2)

Propofol group

ACTIVE COMPARATOR

patients with propofol-based anesthesia

Drug: Propofol

Sevoflurane group

ACTIVE COMPARATOR

patients with sevoflurane-based anesthesia

Drug: Sevoflurane

Interventions

group of patients with propofol-based anesthesia

Also known as: Propofol group
Propofol group

group of patients with sevoflurane-based anesthesia

Also known as: Sevoflurane group
Sevoflurane group

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled to undergo elective cardiac surgery
  • signed written informed consent agreements

You may not qualify if:

  • Emergency operation that could not obtain pre-CPB1 sample
  • Patients who have infectious factor before operation
  • Patients who have immunosuppressive agent for underlying disease before operation
  • Patients who have history of cancer previously
  • Patients who are younger than 19 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

MeSH Terms

Conditions

Heart Valve DiseasesAortic Diseases

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Seong-Hyop Kim, M.D, Ph.D

    Konkuk University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 7, 2014

First Posted

May 13, 2014

Study Start

May 21, 2014

Primary Completion

December 31, 2016

Study Completion

August 10, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations