Sublingual Microcirculation Data of Patients With Systemic Diseases

• Conditions: Sublingual Microcirculation Status
• Interventions: Other: No intervention

• Registration Number: NCT02516215
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-03
• Study First Posted: 2015-08-05
• Study Start: 2015-09
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-17
• Last Update Posted: 2016-10-19
• Primary Completion: 2016-12
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Total small vessel density of sublingual small vessels	Once at enrollment	Total small vessel density will be measured by Microscan and analyzed by AVA 3.0 software

Secondary Outcome Measures

Name	Time	Method
Perfused small vessel density of sublingual small vessels	Once at enrollment	Perfused small vessel density will be measured by Microscan and analyzed by AVA 3.0 software

Trial Locations

Locations (1)

National Taiwan University Hospital, anesthesiology department; 🇨🇳 Taipei, Taiwan