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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

About this trial

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

Eligibility Criteria

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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

Studies a U.S. FDA-regulated Device Product

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

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

Learn more about this trial

Short Daily Versus Conventional Hemodialysis for COVID-19 Patients

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