Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study

Microcirculation Clinical Trial

Official title:

Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03089814
• Other study ID #: RIPC-VOT
• Status: Completed
• Phase: N/A
• First received: March 14, 2017
• Last updated: February 26, 2018
• Start date: March 23, 2017
• Est. completion date: July 10, 2017

Study information

• Verified date: February 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Subjects who are male healthy volunteers (aged 20-45) or who are scheduled to receive cardiac surgery (aged 20-80) will undergo ischemic conditioning, consisting of 4 cycles of 5-min ischemia with pressure of 200 mmHg on upper extremity followed by 5-min reperfusion with no pressure. During ischemic conditioning, changes in tissue microcirculation (baseline tissue saturation, occlusion slope during ischemia, and recovery slope during reperfusion) will be observed using tissue oxygen saturation sensor attached to the thenar muscle of the hand. For cardiac surgery patients, the study will be conducted before anesthesia induction on the surgery day to exclude any potential effect of anesthetics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 10, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

<Healthy volunteers>

Inclusion Criteria:

• Age 20-45

• No underlying chronic disease

• Male volunteer

Exclusion Criteria:

• 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>

Inclusion Criteria:

• Age 20-80

• Scheduled for cardiac surgery

Exclusion Criteria:

• 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

• Any abnormalities on upper extremities (i.e, AV fistula on arms)

• Peripheral vascular disease, peripheral neuropathy, coagulopathy

• Vigorous exercise, excessive alcohol, smoking or caffeine within 24 hours

• Pregnant

• Emergency surgery

• Do not consent to participate

Related Conditions & MeSH terms

• Microcirculation

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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