Clinical trial NCT02516215: Sublingual Microcirculation Data of Patients With Systemic Diseases
Official title: Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sublingual Microcirculation Status
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-08-05
Enrollment: 360
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Total small vessel density of sublingual small vessels
timeFrame: Once at enrollment
Secondary outcomes:
measure: Perfused small vessel density of sublingual small vessels
timeFrame: Once at enrollment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, anesthesiology department
Study officials:
affiliation: National Taiwan University Hospital, Department of Anesthesiology
name: Yu-Chang Yeh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: