Clinical trial NCT04374058: Less Frequency Hemodialysis and COVID-19
Official title: Reduced Frequency Hemodialysis in Prevalent Patients Due to the Coronavirus Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End Stage Renal Disease
Keywords: Covid-19
Dialysis
less frequency hemodialysis
Ultrafiltration rate
Anemia
Nutrition
Lead sponsor: Dialisis Madariaga
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The entire population of our satellite hemodialysis center, except those that meet the exclusion criteria, would be followed by one year

Brief summary: Facing the unusual situation imposed by the coronavirus disease, the aim of this study is to evaluate the risk and effects of less frequent hemodialysis on prevalent patients

Detailed description: The novel coronavirus disease (COVID-19), also known as COVID-19 (and SARS-Cov2) by the World Health Organization, is a rapidly evolving pandemic. The outbreak is expected to infect a large portion of the world population, and a case fatality rate of 1-3% represents a significant mortality and healthcare burden. In common with other viral diseases, mortality is higher in elderly patients with high comorbidity.

The impressive figures of transmission in different communities underline the need for reorganization of efforts to limit contagion, particularly in crowded settings. Hemodialysis centres represents a specific setting in which many patients are repeatedly treated in the same area at the same time.

Dialysis patients constitute a susceptible population because of their older age, high comorbidity burden and their less efficient immune system. Therefore, they are more prone to develop severe infectious diseases than the general population.. Moreover, if infected, the requirements of specialized resources and staff is further complicated by requirements for isolation, control and prevention, putting healthcare systems under additional strain. Therefore, all measures to slow and to control unmanageably high incidence rates must be taken very seriously.

The routine treatment usually requires three dialysis sessions per week Further, some patients must travel long distances to the dialysis centre. One option to reduce the higher risk of these patients is to reduce the frequency of dialysis sessions.However, the potential benefits of reduced risk may be associated with higher interdialytic weight gain and inadequate dialysis, Two factors that increase the risk of mortality. Furthermore, the impact of reduced frequency on Anemia and Nutrition have not been extensively studied.

Eligibility criteria: Inclusion Criteria:

* More than 30 days of Chronic ambulatory in-center hemodialysis

Exclusion Criteria:

* More than three sessions a week
* amputated lower limbs

Primary outcomes:
measure: Mortality
timeFrame: From date of beginning of the study until the date of death assessed up to 52 weeks
Secondary outcomes:
measure: Anemia, Nutrition, Adequation of dialysis, total ultrafiltration, ultrafiltration rate,
timeFrame: From date of beginning of the study assessed up to 52 weeks
measure: Hospitalization
timeFrame: From date of beginning of the study until the date of first hospitalization assessed up to 52 weeks
measure: Vascular Access
timeFrame: From date of beginning of the study until the date of first intervention assessed up to 52 weeks
Other outcomes:
Locations:
city: General Juan Madariaga
country: Argentina
facility: Dialisis Madariaga
state: Buenos Aires
Study officials:
affiliation: Dialisis Madariaga
name: Esteban L Siga, MD
role: PRINCIPAL_INVESTIGATOR
References: