Less Frequency Hemodialysis and COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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Reduced Frequency Hemodialysis in Prevalent Patients Due to the Coronavirus Disease

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Other: less-frequency hemodialysis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 30 days of Chronic ambulatory in-center hemodialysis Exclusion Criteria: More than three sessions a week amputated lower limbs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Two Times<br>The treatment group consists of selected patients that, based on their mean ultrafiltration rate, are switched from thrice-weekly to twice-weekly hemodialysis sessions | Other: less-frequency hemodialysis<br>* Patients of treatment group would be evaluated quarterly<br>|
| Three times<br>Usual thrice-weekly hemodialysis schedule | Other: less-frequency hemodialysis<br>* Patients of treatment group would be evaluated quarterly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Time to all-cause and cardiovascular death | From date of beginning of the study until the date of death assessed up to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anemia, Nutrition, Adequation of dialysis, total ultrafiltration, ultrafiltration rate, | Time variation of the biological parameters mentioned in the title. Repeated measurements of laboratory variables will be averaged into patient quarterly means to minimize measurement variability. | From date of beginning of the study assessed up to 52 weeks | 
| Hospitalization | Time to first hospitalization of any cause | From date of beginning of the study until the date of first hospitalization assessed up to 52 weeks | 
| Vascular Access | Time to first endovascular or quirurgical intervention of the vascular access utilized at the start of the study | From date of beginning of the study until the date of first intervention assessed up to 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, Covid-19, Dialysis, less frequency hemodialysis, Ultrafiltration rate, Nutrition