NCT04374058

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 1, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

May 5, 2020

Status Verified

May 1, 2020

Enrollment Period

12 months

First QC Date

May 1, 2020

Last Update Submit

May 2, 2020

Conditions

End Stage Renal Disease

Keywords

Covid-19Dialysisless frequency hemodialysisUltrafiltration rateAnemiaNutrition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Anemia, Nutrition, Adequation of dialysis, total ultrafiltration, ultrafiltration rate,

    From date of beginning of the study assessed up to 52 weeks

  • Hospitalization

    From date of beginning of the study until the date of first hospitalization assessed up to 52 weeks

  • Vascular Access

    From date of beginning of the study until the date of first intervention assessed up to 52 weeks

Study Arms (2)

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

Three times

Usual thrice-weekly hemodialysis schedule

Other: less-frequency hemodialysis

Interventions

less-frequency hemodialysisOTHER

Patients of treatment group would be evaluated quarterly

Three timesTwo Times

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • More than three sessions a week
  • amputated lower limbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dialisis Madariaga

General Juan Madariaga, Buenos Aires, 7167, Argentina

Location

MeSH Terms

Conditions

Kidney Failure, ChronicCOVID-19Anemia

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Esteban L Siga, MD

    Dialisis Madariaga

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2020

First Posted

May 5, 2020

Study Start

March 20, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

May 5, 2020

Record last verified: 2020-05

Locations

AR(1)