Sublingual Microcirculation StatusNCT02516215
Sublingual Microcirculation Data of Patients With Systemic Diseases
An observational study of Sublingual Microcirculation Status, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Sublingual Microcirculation Status
- How many people
- 360 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2015to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Show all 11Show fewer
- Hematological disorders
- Uncured cancer
- Chronic uncured infection
- Other major disease with limited daily activity
- Non-native speakers
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital, anesthesiology department
Taipei, 100
Yu-Chang Yeh, M.D, Ph.D., 886-2-23123456, tonyyeh@ntuh.gov.tw
About this study
Official title: 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).
- Conditions
- Sublingual Microcirculation Status
- Being tested
- No intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
| Study group | Role | What they receive |
|---|---|---|
| 1_Hypertension | Patients with diagnosed hypertension, without other systemic diseases Receives: Other: No intervention | |
| 2_Diabetes mellitus | Patients with diagnosed diabetes mellitus, without other systemic diseases Receives: Other: No intervention | |
| 3_Hypertension and diabetes mellitus | Patients with both diagnosed hypertension and diabetes mellitus Receives: Other: No intervention | |
| 4_end stage renal disease with hemodialysis | Patients with end stage renal disease with hemodialysis Receives: Other: No intervention | |
| 5_Peripheral arterial occlusive disease | Patients with disgnosed peripheral arterial occlusive disease Receives: Other: No intervention | |
| 6_Coronary artery disease | Patients with diagnosed coronary artery disease Receives: Other: No intervention | |
| 7_liver cirrhosis | Patients with diagnosed liver cirrhosis Receives: Other: No intervention | |
| 8_Anemia | Patients with diagnosed anemia Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total small vessel density of sublingual small vessels
Total small vessel density will be measured by Microscan and analyzed by AVA 3.0 software
Measured: Once at enrollment
Secondary outcomes (1)
Perfused small vessel density of sublingual small vessels
Perfused small vessel density will be measured by Microscan and analyzed by AVA 3.0 software
Measured: Once at enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sublingual Microcirculation StatusStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chang Yeh, M.D., Ph.D., Principal investigator, National Taiwan University Hospital, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02516215
- Sponsor's protocol ID
- 201505008RINA
- Status last verified
- Oct 2016
- First submitted
- 3 Aug 2015
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Research of Sublingual Microcirculation Data of Patients With Systemic Diseases
- ClinicalTrials.gov ID
- NCT02516215
- Acronym / sponsor ID
- 201505008RINA
- Conditions
- Sublingual Microcirculation Status
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 5 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| 1_Hypertension | – | Other: No interventionPatients with diagnosed hypertension, without other systemic diseases |
| 2_Diabetes mellitus | – | Other: No interventionPatients with diagnosed diabetes mellitus, without other systemic diseases |
| 3_Hypertension and diabetes mellitus | – | Other: No interventionPatients with both diagnosed hypertension and diabetes mellitus |
| 4_end stage renal disease with hemodialysis | – | Other: No interventionPatients with end stage renal disease with hemodialysis |
| 5_Peripheral arterial occlusive disease | – | Other: No interventionPatients with disgnosed peripheral arterial occlusive disease |
| 6_Coronary artery disease | – | Other: No interventionPatients with diagnosed coronary artery disease |
| 7_liver cirrhosis | – | Other: No interventionPatients with diagnosed liver cirrhosis |
| 8_Anemia | – | Other: No interventionPatients with diagnosed anemia |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- Patients aged from 20 to 79 years old
- BMI ranged from 18.5 to 27 kg/m2
- Presence of one of the condition
Key exclusion criteria (11 listed)
- 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
- Non-native speakers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention | Other | 1_Hypertension, 2_Diabetes mellitus, 3_Hypertension and diabetes mellitus, 4_end stage renal disease with hemodialysis, 5_Peripheral arterial occlusive disease, 6_Coronary artery disease, 7_liver cirrhosis, 8_Anemia |
Primary outcome
Total small vessel density of sublingual small vessels
Time frame: Once at enrollment
Total small vessel density will be measured by Microscan and analyzed by AVA 3.0 software
1 secondary outcome
Perfused small vessel density of sublingual small vessels
Time frame: Once at enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Chang Yeh, M.D., Ph.D. principal investigator
National Taiwan University Hospital, Department of Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sublingual Microcirculation Status, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yu-Chang Yeh, M.D., Ph.D (886-2-23123456 ext. 62158, tonyyeh@ntuh.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total small vessel density of sublingual small vessels (time frame: Once at enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2016.