MicrocirculationNCT02874781
Microcirculation of Patients With Kidney Transplant
An observational study of Microcirculation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This study measures the sublingual microcirculation of patients with kidney transplant using MicroScan. The data will be compared with data of health volunteers and end stage renal disease patients on hemodialysis. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Microcirculation
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2016to Oct 2016
- 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 kidney transplant
Who may be able to join
- patients with kidney transplant for more than one month
Who cannot join
- Body mass index (BMI) < 18.5 or > 30
- diagnosis of sepsis or trauma, or admitted to intensive care unit within one month before enrollment
- body temperature < 35.5 or > 37.5 Celsius
- patients with tongue resection
- non-native speaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sublingual Microcirculation Data of Patients With Kidney Transplant
This study measures the sublingual microcirculation of patients with kidney transplant using MicroScan. The data will be compared with data of health volunteers and end stage renal disease patients on hemodialysis.
Read the detailed description
This study measures the sublingual microcirculation of patients with kidney transplant using MicroScan. The data will be compared with data of health volunteers and end stage renal disease patients on hemodialysis. The microcirculation date includes total small vessel density, perfused small vessel density, proportion of perfused vessels, microvascular flow index, and heterogeneity index.
- Conditions
- Microcirculation
What is being measured
The primary outcome is the main question the study is designed to answer.
Total small vessel density
Measured: 6 hours
Perfused small vessel density
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study startJul 2016
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrocirculationStudies 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yu-Chang Yeh, PhD, Study chair, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874781
- Sponsor's protocol ID
- 201605035RINC
- Status last verified
- Dec 2016
- First submitted
- 5 Aug 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Microcirculation Data of Patients With Kidney Transplant
- ClinicalTrials.gov ID
- NCT02874781
- Acronym / sponsor ID
- 201605035RINC
- Conditions
- Microcirculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 22 Aug 2016 (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 study measures the sublingual microcirculation of patients with kidney transplant using MicroScan. The data will be compared with data of health volunteers and end stage renal disease patients on hemodialysis.
Detailed description
This study measures the sublingual microcirculation of patients with kidney transplant using MicroScan. The data will be compared with data of health volunteers and end stage renal disease patients on hemodialysis. The microcirculation date includes total small vessel density, perfused small vessel density, proportion of perfused vessels, microvascular flow index, and heterogeneity index.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with kidney transplant
Key inclusion criteria (1 listed)
- patients with kidney transplant for more than one month
Key exclusion criteria (5 listed)
- Body mass index (BMI) < 18.5 or > 30
- diagnosis of sepsis or trauma, or admitted to intensive care unit within one month before enrollment
- body temperature < 35.5 or > 37.5 Celsius
- patients with tongue resection
- non-native speaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total small vessel density
Time frame: 6 hours
Perfused small vessel density
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Individual participant dataSharing planned: No
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Laser Acupuncture for Fatigue in Hemodialysis Patients
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Recruiting
Study on the Improvement of Myocardial Microcirculation After Acute Anterior Myocardial Infarction
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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, PhD study chair
National Taiwan University Hospital
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 Microcirculation, 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 14 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total small vessel density (time frame: 6 hours). The study lists 2 primary outcomes in all. 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 14 Dec 2016.