End Stage Renal DiseaseNCT04374058
Less Frequency Hemodialysis and COVID-19
An observational study of End Stage Renal Disease, run by Dialisis Madariaga at 1 site in Argentina.
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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- less-frequency hemodialysis
- How many people
- 50 participants
- Where
- 1 siteArgentina
- Study dates
- 20 Mar 2020to Mar 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The entire population of our satellite hemodialysis center, except those that meet the exclusion criteria, would be followed by one year
Who may be able to join
- More than 30 days of Chronic ambulatory in-center hemodialysis
Who cannot join
- More than three sessions a week
- amputated lower limbs
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Dialisis Madariaga
General Juan Madariaga, Buenos Aires, 7167
About this study
Official title: 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
Read the 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.
- Conditions
- End Stage Renal Disease
- Being tested
- less-frequency hemodialysis
- Keywords
- Covid-19, Dialysis, less frequency hemodialysis, Ultrafiltration rate, Anemia, Nutrition
- Medical subject headings
- Kidney Failure, Chronic, COVID-19, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
less-frequency hemodialysisOther
Patients of treatment group would be evaluated quarterly
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: less-frequency hemodialysis | |
| Three times | Usual thrice-weekly hemodialysis schedule Receives: Other: less-frequency hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Time to all-cause and cardiovascular death
Measured: From date of beginning of the study until the date of death assessed up to 52 weeks
Secondary outcomes (3)
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.
Measured: From date of beginning of the study assessed up to 52 weeks
Hospitalization
Time to first hospitalization of any cause
Measured: 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
Measured: From date of beginning of the study until the date of first intervention assessed up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start20 Mar 2020
- Primary completionMar 2021 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dialisis Madariaga
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esteban L Siga, MD, Principal investigator, Dialisis Madariaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374058
- Sponsor's protocol ID
- coronavirus
- Status last verified
- May 2020
- First submitted
- 1 May 2020
- Last updated
- 5 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Frequency Hemodialysis in Prevalent Patients Due to the Coronavirus Disease
- ClinicalTrials.gov ID
- NCT04374058
- Acronym / sponsor ID
- coronavirus
- Conditions
- End Stage Renal Disease
- Keywords
- Covid-19, Dialysis, less frequency hemodialysis, Ultrafiltration rate, Anemia, Nutrition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Dialisis MadariagaUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 5 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Two Times | – | Other: less-frequency hemodialysisThe treatment group consists of selected patients that, based on their mean ultrafiltration rate, are switched from thrice-weekly to twice-weekly hemodialysis sessions |
| Three times | – | Other: less-frequency hemodialysisUsual thrice-weekly hemodialysis schedule |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The entire population of our satellite hemodialysis center, except those that meet the exclusion criteria, would be followed by one year
Key inclusion criteria (1 listed)
- More than 30 days of Chronic ambulatory in-center hemodialysis
Key exclusion criteria (2 listed)
- More than three sessions a week
- amputated lower limbs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| less-frequency hemodialysisPatients of treatment group would be evaluated quarterly | Other | Three times, Two Times |
Primary outcome
Mortality
Time frame: From date of beginning of the study until the date of death assessed up to 52 weeks
Time to all-cause and cardiovascular death
3 secondary outcomes
Anemia, Nutrition, Adequation of dialysis, total ultrafiltration, ultrafiltration rate,
Time frame: From date of beginning of the study assessed up to 52 weeks
Hospitalization
Time frame: From date of beginning of the study until the date of first hospitalization assessed up to 52 weeks
Vascular Access
Time frame: From date of beginning of the study until the date of first intervention assessed up to 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2020.
- Individual participant dataSharing planned: Undecided
Related trials for End Stage Renal Disease
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esteban L Siga, MD principal investigator
Dialisis Madariaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Renal Disease, run by Dialisis Madariaga at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From date of beginning of the study until the date of death assessed up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2020.