HemodialysisNCT02023528
Dialysis Registry in Utah
An observational study of Hemodialysis, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis
- How many people
- 243 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: New patients starting on dialysis at the University of Utah care dialysis program.
Who may be able to join
- Must be above the age of 18.
- Consenting to participate in the registry.
Who cannot join
- <18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Hemodialysis
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics, co-morbid conditions and characteristics of dialysis patients
The objective is to develop a registry of incident dialysis patients at the University of Utah dialysis program
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2008
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Prospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srinvasan Beddhu, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023528
- Sponsor's protocol ID
- IRB_00063655
- Status last verified
- Aug 2016
- First submitted
- 23 Dec 2013
- Last updated
- 11 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialysis Registry in Utah
- ClinicalTrials.gov ID
- NCT02023528
- Acronym / sponsor ID
- IRB_00063655
- Conditions
- Hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Dec 2013 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- New patients starting on dialysis at the University of Utah care dialysis program.
Key inclusion criteria (2 listed)
- Must be above the age of 18.
- Consenting to participate in the registry.
Key exclusion criteria (1 listed)
- <18 years of age
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
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
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 11 Aug 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hemodialysis, run by University of Utah at 1 site in United States.
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 2 inclusion and 1 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 11 Aug 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 United States. 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?
Demographics, co-morbid conditions and characteristics of dialysis patients (time frame: baseline). 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 11 Aug 2016.