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Completed

NCT Number: NCT04935827

Seasonal Differences in Home Dialysis Uptake and Initiating Dialysis in the Hospital

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.

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Key information

Conditions

Dialysis Hospitalizations Peritoneal Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • As above

Treatment and study plan

Season of Year

Other

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 dialysis

Other

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

Primary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2007
Primary completion
2017
Study completion
2017
First posted
Jun 23, 2021
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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