Less Frequency Hemodialysis and COVID-19

Reduced Frequency Hemodialysis in Prevalent Patients Due to the Coronavirus Disease

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

Study Overview

• Status: Unknown
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Other: less-frequency hemodialysis

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.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • General Juan Madariaga, Buenos Aires, Argentina, 7167
      • Dialisis Madariaga

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• More than three sessions a week
• amputated lower limbs

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Two Times; 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; Patients of treatment group would be evaluated quarterly
Three times; Usual thrice-weekly hemodialysis schedule	Other: less-frequency hemodialysis; Patients of treatment group would be evaluated quarterly

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Dialisis Madariaga
• Investigators: Principal Investigator: Esteban L Siga, MD, Dialisis Madariaga

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 20, 2020
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): March 1, 2021

Study Registration Dates

• First Submitted: May 1, 2020
• First Submitted That Met QC Criteria: May 2, 2020
• First Posted (ACTUAL): May 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2020
• Last Update Submitted That Met QC Criteria: May 2, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Covid-19; Anemia; Nutrition; Dialysis; less frequency hemodialysis; Ultrafiltration rate
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: coronavirus

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No