Sublingual Microcirculation Data of Patients With Systemic Diseases

Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases

This is an observational clinical study, patients with systemic diseases will be enrolled according to the inclusion and exclusion criteria. 360 patients will received the examination of sublingual microcirculation by using sidestream dark filed video microscope. The microcirculation data includes total small vessel density, perfused small vessel density, microvascular flow index, and heterogeneity index. The patients will be divided into right groups according to their systemic diseases as follows: group 1 hypertension (60 patients), group 2 diabetes mellitus (60), group 3 hypertension and diabetes mellitus (60), group 4 end stage renal disease with hemodialysis (60), group 5 peripheral arterial occlusive disease (30), group 6 coronary artery disease (30), group 7 liver cirrhosis (30), and group 8 anemia (30).

Study Overview

• Status: Unknown
• Conditions: Sublingual Microcirculation Status
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Anticipated): 360

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital, anesthesiology department
    • Contact: Yu-Chang Yeh, M.D, Ph.D.; Phone Number: 886-2-23123456; Email: tonyyeh@ntuh.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with diagnosed hypertension, diabetes mellitus, both hypertension and diabetes mellitus, end stage renal disease with hemodialysis, peripheral arterial occlusive disease, coronary artery disease, liver cirrhosis, or anemia.

Description

Inclusion Criteria:

• Patients aged from 20 to 79 years old
• BMI ranged from 18.5 to 27 kg/m2

• Presence of one of the condition

  1. Diagnosed hypertenison > 6 months, without other systemic diseases
  2. Diagnosed diabetes mellitus > 6 monthes, without other systemic diseases
  3. Diagnosed with both hypertension and diabetes mellitus > 6 months, without other systemic diseases
  4. Diagnosed with end stage renal disease and recevied renal replacement therapy > 6 months
  5. Diagnosed with peripheral arterial occlusive diseases > 6 months
  6. Diagnosed with coronary artery disease > 6 months
  7. Diagnosed with liver cirrhosis > 6 months
  8. Diagnosed with anemia > 6 months, hemoglobin level < 10 g/dL

Exclusion Criteria:

• Diagnosed with sepsis, major tauma, or admission to ICU within one month
• Body temperature higher than 37.5 ℃ or lower than 35.5 ℃

• Any on of the following condition

  1. Asthma
  2. Chronic obstructive pulmonary disease
  3. Endocrine diseases
  4. Hematological disorders
  5. Uncured cancer
  6. Chronic uncured infection
  7. Other major disease with limited daily activity
• Non-native speakers

Study Plan

How is the study designed?

Number of groups / cohorts

8

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1_Hypertension; Patients with diagnosed hypertension, without other systemic diseases	Other: No intervention
2_Diabetes mellitus; Patients with diagnosed diabetes mellitus, without other systemic diseases	Other: No intervention
3_Hypertension and diabetes mellitus; Patients with both diagnosed hypertension and diabetes mellitus	Other: No intervention
4_end stage renal disease with hemodialysis; Patients with end stage renal disease with hemodialysis	Other: No intervention
5_Peripheral arterial occlusive disease; Patients with disgnosed peripheral arterial occlusive disease	Other: No intervention
6_Coronary artery disease; Patients with diagnosed coronary artery disease	Other: No intervention
7_liver cirrhosis; Patients with diagnosed liver cirrhosis	Other: No intervention
8_Anemia; Patients with diagnosed anemia	Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total small vessel density of sublingual small vessels	Total small vessel density will be measured by Microscan and analyzed by AVA 3.0 software	Once at enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfused small vessel density of sublingual small vessels	Perfused small vessel density will be measured by Microscan and analyzed by AVA 3.0 software	Once at enrollment

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Yu-Chang Yeh, M.D., Ph.D., National Taiwan University Hospital, department of anesthesiology

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: August 3, 2015
• First Submitted That Met QC Criteria: August 3, 2015
• First Posted (Estimate): August 5, 2015

Study Record Updates

• Last Update Posted (Estimate): October 19, 2016
• Last Update Submitted That Met QC Criteria: October 17, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 201505008RINA