NCT02516215

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
27 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 19, 2016

Status Verified

October 1, 2016

Enrollment Period

1.3 years

First QC Date

August 3, 2015

Last Update Submit

October 17, 2016

Conditions

Sublingual Microcirculation Status

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Perfused small vessel density of sublingual small vessels

    Once at enrollment

Study Arms (8)

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

Interventions

No interventionOTHER
1_Hypertension2_Diabetes mellitus3_Hypertension and diabetes mellitus4_end stage renal disease with hemodialysis5_Peripheral arterial occlusive disease6_Coronary artery disease7_liver cirrhosis8_Anemia

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Patients aged from 20 to 79 years old
  • BMI ranged from 18.5 to 27 kg/m2
  • Presence of one of the condition
  • Diagnosed hypertenison \> 6 months, without other systemic diseases
  • Diagnosed diabetes mellitus \> 6 monthes, without other systemic diseases
  • Diagnosed with both hypertension and diabetes mellitus \> 6 months, without other systemic diseases
  • Diagnosed with end stage renal disease and recevied renal replacement therapy \> 6 months
  • Diagnosed with peripheral arterial occlusive diseases \> 6 months
  • Diagnosed with coronary artery disease \> 6 months
  • Diagnosed with liver cirrhosis \> 6 months
  • Diagnosed with anemia \> 6 months, hemoglobin level \< 10 g/dL

You may not qualify if:

  • 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
  • Asthma
  • Chronic obstructive pulmonary disease
  • Endocrine diseases
  • Hematological disorders
  • Uncured cancer
  • Chronic uncured infection
  • Other major disease with limited daily activity
  • Non-native speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital, anesthesiology department

Taipei, 100, Taiwan

RECRUITING

Study Officials

  • Yu-Chang Yeh, M.D., Ph.D.

    National Taiwan University Hospital, Department of Anesthesiology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Chang Yeh, M.D., Ph.D

CONTACT

886-2-23123456tonyyeh@ntuh.gov.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 5, 2015

Study Start

September 1, 2015

Primary Completion

December 1, 2016

Study Completion

January 1, 2017

Last Updated

October 19, 2016

Record last verified: 2016-10

Locations

TW(1)