Muscle Mass or Muscle Function as a prédictive Tools for... | NCT03845452

Studies
Muscle Mass or Muscle Function as a prédictive Tools for Outtcomme in Chronic Dialysis Patients

NCT03845452

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Sep 9, 2020Actual

Enrollment

187Actual

Phase

Not provided

Conditions

Chrnoic Haemodialysis Patients

Interventions

Not provided

Countries

France

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

Feb 2019

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

Jan 1, 2016Actual

Primary Completion Date

Jan 1, 2019Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

Feb 18, 2019

First Submission Date that Met QC Criteria

Feb 18, 2019

First Posted Date

Feb 19, 2019Actual

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

Sep 4, 2020

Last Update Posted Date

Sep 9, 2020Actual

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

Aim of this study is to compare the association of muscle mass and functionality with mortality among chronic haemodialysis

the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C reactive protein and decrease in serum albumin) on voluntary muscle strength impairment and phyiscal activity.
the relationship between voluntary muscle strength and mortality
the relationship between voluntary muscle strength and physical activity

Detailed Description

Aim of this study is to compare the association of muscle mass and functionality with mortality among chronic haemodialysis

the involvement of malnutrition inflammation and atherogenesis syndrome (increase in C reactive protein and decrease in serum albumin) on voluntary muscle strength impairment and phyiscal activity.
the relationship between voluntary muscle strength and mortality
the relationship between voluntary muscle strength and physical activity

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

187Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality at 2 years	Mortality at 2 years	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

chronic kidney disease patient with extrarenal replacement therapy by hemodialysis for at least 3 months
stable clinical condition (absence of infection, stroke or acute decompensation)

Exclusion criteria:

chronic kidney disease without extrarenal replacement therapy
history of renal transplantation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Chrnoic haemodialysis patients

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Paul CRISTOL, Prof	CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34290	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38983653	Derived	Souweine JS, Pasquier G, Morena M, Patrier L, Rodriguez A, Raynal N, Ohresser I, Benomar R, Hayot M, Mercier J, Gouzi F, Cristol JP. Beyond sarcopenia: frailty in chronic haemodialysis patients. Clin Kidney J. 2024 Jun 29;17(7):sfae069. doi: 10.1093/ckj/sfae069. eCollection 2024 Jul.

ID	Term
D051436	Renal Insufficiency, Chronic
D009043	Motor Activity

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases