Short Daily Versus Conventional Hemodialysis for COVID-19 Patients
Primary Purpose
COVID-19
Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Short daily dialysis
Sponsored by

About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Dialysis
Eligibility Criteria
Inclusion Criteria:
- ESRD patients >3months on hemodialysis admitted for COVID-19
Exclusion Criteria:
- ESRD patients <3 months on hemodialysis infected with COVID-19
Sites / Locations
- Nooshin Dalili
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
short daily dialysis
conventional dialysis
Arm Description
7 days 2hours dialysis
3 times weekly 4hours dialysis
Outcomes
Primary Outcome Measures
Mortality
discharged or dead
ICU add
admission to ICU or not
Secondary Outcome Measures
Full Information
NCT ID
NCT05212675
First Posted
January 24, 2022
Last Updated
January 26, 2022
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05212675
Brief Title
Short Daily Versus Conventional Hemodialysis for COVID-19 Patients
Official Title
Short Daily Versus Conventional Hemodialysis for COVID-19 Patients: A Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Dialysis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
short daily dialysis
Arm Type
Other
Arm Description
7 days 2hours dialysis
Arm Title
conventional dialysis
Arm Type
No Intervention
Arm Description
3 times weekly 4hours dialysis
Intervention Type
Other
Intervention Name(s)
Short daily dialysis
Intervention Description
7 days 2hours dialysis
Primary Outcome Measure Information:
Title
Mortality
Description
discharged or dead
Time Frame
From date of randomization until the date of first documented progression or date of death
Title
ICU add
Description
admission to ICU or not
Time Frame
From date of randomization until the date of first documented progression or date of death
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ESRD patients >3months on hemodialysis admitted for COVID-19
Exclusion Criteria:
ESRD patients <3 months on hemodialysis infected with COVID-19
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nooshin Dalili, MD
Organizational Affiliation
SBMU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nooshin Dalili
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Short Daily Versus Conventional Hemodialysis for COVID-19 Patients
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