Hemodialysis Clinical Trial
Official title:
Dialysis Registry in Utah
Based on the Medicare data, the 5-year survival of dialysis patients is only 39%. This is lower than that of stage IIIB breast cancer (54% 5-year survival). The annual mortality of dialysis patients is ~ 23% compared to <0.1% in the United States general population. Even kidney transplant recipients have a substantially higher mortality (~7%) compared to the general population. Consequently, the life-expectancy of dialysis and transplant populations is much lower than that of the general population. Cardiovascular events are the leading cause of death in dialysis patients and malnutrition is also a strong risk factor for death. The current proposal is to develop a prospective registry of incident dialysis patients at the University of Utah dialysis program to examine cardiovascular and nutritional factors in dialysis patients. This registry will include clinical and administrative data. In addition, blood samples will be stored for future analyses.
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).
;
Observational Model: Cohort, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04892745 -
Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance
|
||
Not yet recruiting |
NCT04925674 -
Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis.
|
Phase 1 | |
Active, not recruiting |
NCT03183245 -
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
|
Phase 3 | |
Completed |
NCT03365635 -
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
|
Phase 4 | |
Withdrawn |
NCT02904343 -
Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study
|
N/A | |
Withdrawn |
NCT01855334 -
L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD
|
Phase 4 | |
Completed |
NCT01700465 -
Estimating and Predicting Hemodynamic Changes During Hemodialysis
|
N/A | |
Recruiting |
NCT01195519 -
The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis
|
N/A | |
Completed |
NCT00737672 -
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
|
Phase 3 | |
Completed |
NCT00527774 -
Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients
|
N/A | |
Completed |
NCT00942253 -
Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS)
|
Phase 2 | |
Completed |
NCT00850252 -
Use of a Lifeline Graft in the A-V Shunt Model
|
Phase 1/Phase 2 | |
Completed |
NCT00224081 -
DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
|
Phase 4 | |
Completed |
NCT00776750 -
Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients
|
Phase 4 | |
Recruiting |
NCT06351007 -
Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK)
|
N/A | |
Withdrawn |
NCT03664141 -
Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study)
|
Phase 3 | |
Completed |
NCT03909698 -
Antibiotic Dosing in Patients on Intermittent Hemodialysis
|
||
Recruiting |
NCT03311321 -
Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients
|
N/A | |
Recruiting |
NCT06098924 -
HD Patients' Depression and Happiness
|
||
Recruiting |
NCT03419923 -
Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage
|
N/A |