Less Frequency Hemodialysis and COVID-19

End Stage Renal Disease Clinical Trial

Official title:

Reduced Frequency Hemodialysis in Prevalent Patients Due to the Coronavirus Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04374058
• Other study ID #: coronavirus
• Status: Active, not recruiting
• Start date: March 20, 2020
• Est. completion date: March 2021

Study information

• Verified date: May 2020
• Source: Dialisis Madariaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• More than three sessions a week

• amputated lower limbs

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Other:
• less-frequency hemodialysis
Patients of treatment group would be evaluated quarterly

Locations

Country	Name	City	State
Argentina	Dialisis Madariaga	General Juan Madariaga	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Dialisis Madariaga

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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