NCT06477978

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
274

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 13, 2022

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 20, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 27, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

June 20, 2024

Last Update Submit

June 26, 2024

Conditions

Keywords

sarcopeniaend stage renal diseaseend stage kidney diseasedialysis dependent end stage renal disease

Outcome Measures

Primary Outcomes (1)

  • One year mortality

    All cause mortality of patients with end stage kidney disease on hemodialysis

    One year

Study Arms (1)

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

The use of Bio-impedance to measure the skeletal muscle mass

Also known as: Measuring skeletal body mass using bio-impedance analysis ( BIA)
End stage kidney disease patient on maintenance hemodialysis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with End stage kidney disease on maintenance dialysis

You may not qualify if:

  • unable to consent or terminal malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy University Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Kidney Failure, ChronicSarcopenia

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMuscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalSigns and Symptoms

Study Officials

  • Tarek Abdelaziz, PhD

    Kasr El Aini Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: This is cohort prospective study of end stage kidney disease patients on hemodialysis
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Internal medicine and nephrology

Study Record Dates

First Submitted

June 20, 2024

First Posted

June 27, 2024

Study Start

February 15, 2021

Primary Completion

May 13, 2022

Study Completion

March 15, 2023

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Upon reasonable request

Locations