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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
Shahid Beheshti University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Dialysis

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 24, 2022
Last Updated
January 26, 2022
Sponsor
Shahid Beheshti University of Medical Sciences
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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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