DialysisNCT04935827
Seasonal Differences in Home Dialysis Uptake and Initiating Dialysis in the Hospital
An observational study of Dialysis and Peritoneal Dialysis, run by University of Southern California.
Trial summary
This study will investigate whether home dialysis uptake varies by the season of year. We will also investigate whether hospitalizations around the time of dialysis also vary by season of year and whether hospitalizations are associated with reduced home dialysis starts and sustained home dialysis uptake. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis, Peritoneal Dialysis, Hospitalizations
- What is being tested?
- Season of Year and Hospitalized 14 days prior to dialysis
- How many people
- 400,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2007to 30 Nov 2017
- 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: All adults with fee-for-service Medicare coverage initiating dialysis for end-stage kidney disease in the United States from 12/1/2007-11/30/2017
Who may be able to join
- Started dialysis in the USA for end-stage kidney disease from 12/1/2007-11/30/2017
- No transplant or death prior to day 90 of dialysis
- Medicare Parts A/B as primary payer 30 days prior to starting dialysis
- Valid Medicare Evidence Form (Form 2728)
Who cannot join
- As above
About this study
This study will investigate whether home dialysis uptake varies by the season of year. We will also investigate whether hospitalizations around the time of dialysis also vary by season of year and whether hospitalizations are associated with reduced home dialysis starts and sustained home dialysis uptake.
- Conditions
- Dialysis, Peritoneal Dialysis, Hospitalizations
- Being tested
- Season of Year, Hospitalized 14 days prior to dialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Season of YearOther
We stratify patients into 4 groups based on the season of the year (between 12/1/2007-11/30/2017)
- Winter: December, January, February
- Spring: March, April, May
- Summer: June, July, August
- Fall: September, October, November
Hospitalized 14 days prior to dialysisOther
We further stratify patients into 3 groups based on whether they were hospitalized within 14 days prior to dialysis
- Group 1: No hospitalization prior to dialysis
- Group 2: Hospitalized within 14 days prior to dialysis for an acute infectious respiratory condition or one of the following acute cardiac conditions (arrhythmia, myocardial infarction, stroke, or fluid overload)
- Group 3: Hospitalized within 14 days prior to dialysis for a condition not in Group 2
| Study group | Role | What they receive |
|---|---|---|
| Patients initiating dialysis for end-stage kidney disease | Patients whose start of dialysis is from 12/1/2007-11/30/2017. We use the following inclusion criteria:
* Adult (>= 18 years old)
* Did not die or have a transplant prior to the 90th day of dialysis
* Valid medical evidence form
* Medicare Part A/B as primary payer in the 30 days prior to initiating dialysis
* Initiating dialysis in the USA Receives: Other: Season of Year; Other: Hospitalized 14 days prior to dialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of dialysis modality at the start of dialysis
Whether patient started with home dialysis or in-center dialysis at the start of dialysis
Measured: Day 1 of dialysis
Type of dialysis modality at the end of month 3 of dialysis
Whether patient was using home dialysis or in-center dialysis at the end of month 3 of dialysis (day 84)
Measured: End of month 3 of dialysis
Type of dialysis modality at the end of month 6 of dialysis
Whether patient was using home dialysis or in-center dialysis at the end of month 6 of dialysis (day 168)
Measured: End of month 6 of dialysis
Type of dialysis modality at the end of month 9 of dialysis
Whether patient was using home dialysis or in-center dialysis at the end of month 9 of dialysis (day 252)
Measured: End of month 9 of dialysis
Type of dialysis modality at the end of month 12 of dialysis
Whether patient was using home dialysis or in-center dialysis at the end of month 12 of dialysis (day 336)
Measured: End of month 12 of dialysis
Mortality in the first year
Whether the patient died in the first year of dialysis and the number of days the patient survived
- Censored for transplantation, loss to follow-up
Measured: 1 year of dialysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start1 Dec 2007
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DialysisStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Retrospective
- Enrolment
- 400,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eugene Lin, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935827
- Sponsor's protocol ID
- HS-18-00530-2
- Other IDs
- K08DK118213
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 23 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are protected by a DUA from the United States Renal Data System. Researchers interested in obtaining the data must obtain a DUA. We will share programs to generate the analyses via an open source sharing resource.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seasonal Differences in Home Dialysis Uptake and Initiating Dialysis in the Hospital
- ClinicalTrials.gov ID
- NCT04935827
- Acronym / sponsor ID
- HS-18-00530-2
- Conditions
- Dialysis, Peritoneal Dialysis, Hospitalizations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400,000 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Dec 2007 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 23 Jun 2021 (actual)
- 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 will investigate whether home dialysis uptake varies by the season of year. We will also investigate whether hospitalizations around the time of dialysis also vary by season of year and whether hospitalizations are associated with reduced home dialysis starts and sustained home dialysis uptake.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients initiating dialysis for end-stage kidney disease | – | Other: Season of Year, Other: Hospitalized 14 days prior to dialysisPatients whose start of dialysis is from 12/1/2007-11/30/2017. We use the following inclusion criteria: * Adult (>= 18 years old) * Did not die or have a transplant prior to the 90th day of dialysis * Valid medical evidence form * Medicare Part A/B as primary payer in the 30 days prior to initiating dialysis * Initiating dialysis in the USA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adults with fee-for-service Medicare coverage initiating dialysis for end-stage kidney disease in the United States from 12/1/2007-11/30/2017
Key inclusion criteria (4 listed)
- Started dialysis in the USA for end-stage kidney disease from 12/1/2007-11/30/2017
- No transplant or death prior to day 90 of dialysis
- Medicare Parts A/B as primary payer 30 days prior to starting dialysis
- Valid Medicare Evidence Form (Form 2728)
Key exclusion criteria (1 listed)
- As above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Season of YearWe stratify patients into 4 groups based on the season of the year (between 12/1/2007-11/30/2017) * Winter: December, January, February * Spring: March, April, May * Summer: June, July, August * Fall: September, October, November | Other | Patients initiating dialysis for end-stage kidney disease |
| Hospitalized 14 days prior to dialysisWe further stratify patients into 3 groups based on whether they were hospitalized within 14 days prior to dialysis * Group 1: No hospitalization prior to dialysis * Group 2: Hospitalized within 14 days prior to dialysis for an acute infectious respiratory condition or one of the following acute cardiac conditions (arrhythmia, myocardial infarction, stroke, or fluid overload) * Group 3: Hospitalized within 14 days prior to dialysis for a condition not in Group 2 | Other | Patients initiating dialysis for end-stage kidney disease |
Primary outcome
Type of dialysis modality at the start of dialysis
Time frame: Day 1 of dialysis
Whether patient started with home dialysis or in-center dialysis at the start of dialysis
Type of dialysis modality at the end of month 3 of dialysis
Time frame: End of month 3 of dialysis
Whether patient was using home dialysis or in-center dialysis at the end of month 3 of dialysis (day 84)
Type of dialysis modality at the end of month 6 of dialysis
Time frame: End of month 6 of dialysis
Whether patient was using home dialysis or in-center dialysis at the end of month 6 of dialysis (day 168)
Type of dialysis modality at the end of month 9 of dialysis
Time frame: End of month 9 of dialysis
Whether patient was using home dialysis or in-center dialysis at the end of month 9 of dialysis (day 252)
Type of dialysis modality at the end of month 12 of dialysis
Time frame: End of month 12 of dialysis
Whether patient was using home dialysis or in-center dialysis at the end of month 12 of dialysis (day 336)
Mortality in the first year
Time frame: 1 year of dialysis
Whether the patient died in the first year of dialysis and the number of days the patient survived - Censored for transplantation, loss to follow-up
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 23 Jun 2021.
- Individual participant dataSharing planned: No. Data are protected by a DUA from the United States Renal Data System. Researchers interested in obtaining the data must obtain a DUA. We will share programs to generate the analyses via an open source sharing resource.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Dialysis and Peritoneal Dialysis, run by University of Southern California.
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 4 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 23 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Type of dialysis modality at the start of dialysis (time frame: Day 1 of dialysis). The study lists 6 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 23 Jun 2021.