Less Frequency Hemodialysis and COVID-19

NCT ID: NCT04374058

Last Updated: 2020-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-20

Study Completion Date

2021-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End Stage Renal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

less-frequency hemodialysis

Intervention Type OTHER

Patients of treatment group would be evaluated quarterly

Three times

Usual thrice-weekly hemodialysis schedule

less-frequency hemodialysis

Intervention Type OTHER

Patients of treatment group would be evaluated quarterly

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

less-frequency hemodialysis

Patients of treatment group would be evaluated quarterly

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* More than three sessions a week
* amputated lower limbs
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Dialisis Madariaga

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Esteban L Siga, MD

Role: PRINCIPAL_INVESTIGATOR

Dialisis Madariaga

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dialisis Madariaga

General Juan Madariaga, Buenos Aires, Argentina

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Argentina

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

coronavirus

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.