NCT02874781

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 5, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 22, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 14, 2016

Status Verified

December 1, 2016

Enrollment Period

3 months

First QC Date

August 5, 2016

Last Update Submit

December 12, 2016

Conditions

Microcirculation

Outcome Measures

Primary Outcomes (2)

  • Total small vessel density

    6 hours

  • Perfused small vessel density

    6 hours

Eligibility Criteria

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

Patients with kidney transplant

You may qualify if:

  • patients with kidney transplant for more than one month

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

  • Yu-Chang Yeh, PhD

    National Taiwan University Hospital

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 22, 2016

Study Start

July 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

December 14, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)