The Prevalence of Sarcopenia in a Cohort of Haemodialysis... | NCT06477978

Studies
The Prevalence of Sarcopenia in a Cohort of Haemodialysis Patients and Its Correlation With Mortality

NCT06477978

Sponsor

Kasr El Aini Hospital

Status

Completed

Last Update Posted

Jun 27, 2024Actual

Enrollment

274Actual

Phase

Not Applicable

Conditions

End-stage Kidney Disease
End-stage Renal Disease
Dialysis Dependent Chronic Kidney Disease
Sarcopenia

Interventions

Hand grip function testing

Countries

Egypt

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

Jun 2024

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

Feb 15, 2021Actual

Primary Completion Date

May 13, 2022Actual

Completion Date

Mar 15, 2023Actual

First Submitted Date

Jun 20, 2024

First Submission Date that Met QC Criteria

Jun 26, 2024

First Posted Date

Jun 27, 2024Actual

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

Jun 26, 2024

Last Update Posted Date

Jun 27, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tarek Samy Abdelaziz, Associate professor of Internal medicine and nephrology, Kasr El Aini HospitalPrincipal Investigator

Lead Sponsor

Kasr El Aini HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

The study aims to explore the correlation between the prevalence of sarcopenia and one year mortality amongst patients on maintenance hemodialysis

Detailed Description

In our study , we aim to explore the correlation between the prevalence of sarcopenia and one year mortality among patients on maintenance hemodialysis The lean muscle mass was measured using bio-impedance analysis (BIA ). The hand-grip test was used to measure the function .

Sarcopenia was defined using European Working Group on Sarcopenia in Older people (EWGSOP) definition which involves reduced muscle function and reduced muscle mass

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

274Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
End stage kidney disease patient on maintenance hemodialysis	Other	All patient that have been recruited with have the lean body mass index measured sing the Bio-impedance analysis ( BIA )	Diagnostic Test: Hand grip function testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hand grip function testing	Diagnostic Test	The use of Bio-impedance to measure the skeletal muscle mass	End stage kidney disease patient on maintenance hemodialysis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
One year mortality	All cause mortality of patients with end stage kidney disease on hemodialysis	One year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with End stage kidney disease on maintenance dialysis

Exclusion Criteria:

unable to consent or terminal malignancy

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tarek Abdelaziz, PhD	Kasr El Aini Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kasr Alainy University Hospitals		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Upon reasonable request

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007676	Kidney Failure, Chronic
D055948	Sarcopenia

Ancestor Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided