- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02023528
Dialysis Registry in Utah
Study Overview
Status
Conditions
Detailed Description
Design:
This is a prospective, observational study of patients in the University of Utah dialysis program.
Study Procedures:
Patients new to dialysis at the University of Utah dialysis program will be approached to determine whether they want to participate in the registry. If they are interested, the study purpose and procedures will be explained and informed consent obtained. Participants will be asked to complete a brief questionnaire on demographics (age, gender, race, education), co-morbid conditions (diabetes mellitus, congestive heart failure, hypertension, chronic lung disease, malignancies, coronary artery disease, cerebrovascular disease and peripheral vascular disease), physical activity level, cognitive function and sleep patterns. Height, weight, and waist circumference will be measured. Annual follow up visits will be conducted with each patient until the 5th annual follow-up, death, transplantation or loss to follow-up. During these visits, participants will complete questionnaires on physical activity level, cognitive function and sleep patterns. Height, weight, and waist circumference will be measured. Thirty milliliters (ml) of blood will also be drawn.
Relevant Dialysis data (cause and duration of kidney disease, duration of dialytic therapy, duration and frequency of dialysis sessions, type of dialyzer used, type of vascular access), medications (erythropoietin dose and route of administration, iron supplements), laboratory markers (hemoglobin, serum calcium, serum intact parathyroid hormone, serum phosphorous, white blood cell count with differential neutrophil and lymphocyte counts and urea reduction rate) will be obtained from the electronic medical records.
30 ml of blood will be drawn on a dialysis day before dialysis. Serum/ plasma will be separated. DNA will be extracted from the rest of the cells in the baseline visit and stored. The samples will be stored in a freezer for future analyses.
Participants will be longitudinally followed using the dialysis unit electronic medical records and with annual follow up visits. In addition, if the participant consents, Medicare follow-up data from the United States Renal Data System (USRDS) will be obtained. The USRDS is a national registry of dialysis patients. U.S. Medicare regulations stipulate that irrespective of their insurance status, all patients starting on chronic dialysis therapy must be reported to the USRDS. The outcomes of these patients are tracked by USRDS using the Medicare database and national Vital Statistics (maintained by National Center for Health Statistics).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Utah
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Salt Lake City, Utah, United States, 84108
- University of Utah
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Must be above the age of 18.
- Consenting to participate in the registry.
Exclusion Criteria:
- <18 years of age
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Demographics, co-morbid conditions and characteristics of dialysis patients
Time Frame: baseline
|
The objective is to develop a registry of incident dialysis patients at the University of Utah dialysis program
|
baseline
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- IRB_00063655
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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