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Completed

NCT Number: NCT03089814

Changes in Tissue Microcirculation During Ischemic Conditioning: Pilot Study

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.

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Key information

Conditions

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

<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

Treatment and study plan

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.

Primary outcomes

  1. Changes in microcirculation during ischemic conditioning

    Time frame: During 4-cycles of 5-min ischemia followed by 5-min reperfusion

    Changes in occlusion slope during ischemia and recovery slope during reperfusion

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 24, 2017
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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