Short Daily Versus Conventional Hemodialysis for COVID-19 Patients

January 26, 2022 updated by: nooshin dalili, Shahid Beheshti University of Medical Sciences

Short Daily Versus Conventional Hemodialysis for COVID-19 Patients: A Randomized Study

Treatment of dialysis patients involved with COVID-19 with short daily hemodialysis has been supposed to improve short term outcome. It is unclear if short daily dialysis would optimize mortality or ICU admission in routine dialysis patients with COVID-19.

Also the potential variants according with worse outcomes remain to be fully elucidated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

investigators undertook a randomized trial in ESRD patients infected with COVID-19 to determine: 1) if short-daily hemodialysis is associated with a reduction in mortality and ICU admission in one weak period and; 2) the potential effective variants in worst outcome. . Paperwork for the trial was submitted to the shaheed beheshti university of medical sciences in June 2021 for registration . The protocol for this trial and supporting CONSORT checklist are available. The SBMU Ethics Board approved the study and all amendments. The study was conducted according to the Declaration of Helsinki.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ESRD patients >3months on hemodialysis admitted for COVID-19

Exclusion Criteria:

  • ESRD patients <3 months on hemodialysis infected with COVID-19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: short daily dialysis
7 days 2hours dialysis
Other: Short daily dialysis
7 days 2hours dialysis
NO_INTERVENTION: conventional dialysis
3 times weekly 4hours dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: From date of randomization until the date of first documented progression or date of death
discharged or dead
From date of randomization until the date of first documented progression or date of death
ICU add
Time Frame: From date of randomization until the date of first documented progression or date of death
admission to ICU or not
From date of randomization until the date of first documented progression or date of death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Beheshti University of Medical Sciences

Investigators

  • Principal Investigator: Nooshin Dalili, MD, SBMU

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ACTUAL)

June 1, 2021

Study Completion (ACTUAL)

August 30, 2021

Study Registration Dates

First Submitted

January 24, 2022

First Submitted That Met QC Criteria

January 26, 2022

First Posted (ACTUAL)

January 28, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 28, 2022

Last Update Submitted That Met QC Criteria

January 26, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBMU-1400-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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