Chrnoic Haemodialysis PatientsNCT03845452
Muscle Mass or Muscle Function as a prédictive Tools for Outtcomme in Chronic Dialysis Patients
An observational study of Chrnoic Haemodialysis Patients, run by University Hospital, Montpellier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chrnoic Haemodialysis Patients
- How many people
- 187 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2016to 31 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chrnoic haemodialysis patients
Who may be able to join
- 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)
Who cannot join
- chronic kidney disease without extrarenal replacement therapy
- history of renal transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Study : Muscle Mass or Muscle Function as a prédictive Tools for Outtcomme in Chronic Dialysis Patients
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
Read the 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
- Conditions
- Chrnoic Haemodialysis Patients
- Keywords
- chronic kidney disease, muscle strength, muscle mass, lean body mass, physical activity
- Medical subject headings
- Renal Insufficiency, Chronic, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 2 years
Mortality at 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start1 Jan 2016
- Primary completion1 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chrnoic Haemodialysis PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Paul CRISTOL, Prof, Principal investigator, CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845452
- Sponsor's protocol ID
- RECHMPL18_0447
- Status last verified
- Feb 2019
- First submitted
- 18 Feb 2019
- Last updated
- 9 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38983653
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study : Muscle Mass or Muscle Function as a prédictive Tools for Outtcomme in Chronic Dialysis Patients
- ClinicalTrials.gov ID
- NCT03845452
- Acronym / sponsor ID
- RECHMPL18_0447
- Conditions
- Chrnoic Haemodialysis Patients
- Keywords
- chronic kidney disease, muscle strength, muscle mass, lean body mass, physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 19 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chrnoic haemodialysis patients
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- chronic kidney disease without extrarenal replacement therapy
- history of renal transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mortality at 2 years
Time frame: 2 years
Mortality at 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Derived from this study: PubMed 38983653Souweine 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Paul CRISTOL, Prof principal investigator
CHU Lapeyronie, Department of Biochemistry and Hormonology, Montpellier, FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chrnoic Haemodialysis Patients, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality at 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03845452, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.