Short Daily Versus Conventional Hemodialysis for COVID-19... | NCT05212675

Studies
Short Daily Versus Conventional Hemodialysis for COVID-19 Patients

NCT05212675

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Jan 28, 2022Actual

Enrollment

47Actual

Phase

Not Applicable

Conditions

COVID-19

Interventions

Short daily dialysis

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2021Actual

Primary Completion Date

Jun 1, 2021Actual

Completion Date

Aug 30, 2021Actual

First Submitted Date

Jan 24, 2022

First Submission Date that Met QC Criteria

Jan 26, 2022

First Posted Date

Jan 28, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2022

Last Update Posted Date

Jan 28, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

nooshin dalili, Assistant Professor, Shahid Beheshti University of Medical SciencesPrincipal Investigator

Lead Sponsor

Shahid Beheshti University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

47Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
short daily dialysis	Other	7 days 2hours dialysis	Other: Short daily dialysis
conventional dialysis	No Intervention	3 times weekly 4hours dialysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Short daily dialysis	Other	7 days 2hours dialysis	short daily dialysis

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Nooshin Dalili, MD	SBMU	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided