Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study

NCT03089814 | Completed DMC

• 1 other identifier: RIPC-VOT
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Changes in tissue microcirculation during ischemic conditioning (4 cycles of 5-min ischemia and 5-min reperfusion) has not been well documented. In previous studies, there was difference in changes in microcirculation, such as recovery slope and occlusion slope, between healthy subjects and cardiac surgery patients. Moreover, the occlusion slope, which reflects local tissue oxygen consumption during ischemic period, is anticipated to decrease during repeated ischemia-reperfusion cycle by its protecting effect, however there has not been well-conducted study. The purpose of the study is to evaluate the changes in microcirculation measured by tissue oxygen saturation during ischemic conditioning between healthy volunteers and cardiac surgery patients.

Conditions

Microcirculation

Keywords

tissue oxygen saturation, ischemic conditioning

Outcome Measures

Primary Outcomes (1)

• Changes in microcirculation during ischemic conditioning

  Changes in occlusion slope during ischemia and recovery slope during reperfusion

  During 4-cycles of 5-min ischemia followed by 5-min reperfusion

Study Arms (2)

Healthy volunteers

ACTIVE COMPARATOR

Healthy male volunteers will receive ischemic conditioning (4 cycles of 5-min ischemia followed by 5-min reperfusion on upper extremity) while measuring changes in tissue microcirculation at the thenar muscle.

Procedure: ischemic conditioning

Cardiac surgery patients

ACTIVE COMPARATOR

Patients scheduled for cardiac surgery will receive ischemic conditioning (4 cycles of 5-min ischemia followed by 5-min reperfusion on upper extremity) while measuring changes in tissue microcirculation at the thenar muscle.

Procedure: ischemic conditioning

Interventions

ischemic conditioning PROCEDURE

Four cycles of 5-min inflation of pneumatic cuff on upper extremity up to 200 mmHg, followed by 5-min deflation with no pressure.

Cardiac surgery patients; Healthy volunteers

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 20-45
• No underlying chronic disease
• Male volunteer

You may not qualify if:

• Under taking prescription drugs
• Taking herbal medicines within 2 weeks
• Baseline systolic blood pressure \> 150 mmHg or diastolic pressure \> 100 mmHg
• Body mass index \< 18 kg/m\^2 or \> 30 kg/m\^2
• Vigorous exercise, excessive alcohol, smoking or caffeine within 24 hours
• Any abnormalities on upper extremities
• Do not consent to participate
• \<Cardiac surgery patients\>
• Age 20-80
• Scheduled for cardiac surgery
• Baseline systolic blood pressure \> 150 mmHg or diastolic pressure \> 100 mmHg
• Body mass index \< 18 kg/m\^2 or \> 30 kg/m\^2
• Uncontrolled diabetes
• Under taking beta-blockers
• Severe renal dysfunction, chronic kidney disease, on hemodialysis

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Officials

• Yunseok Jeon, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 24, 2017
• Study Start: March 23, 2017
• Primary Completion: July 10, 2017
• Study Completion: July 10, 2017
• Last Updated: February 28, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)