Renal Failure Chronic Requiring DialysisECHOTnTNCT02446639
Assessment the Dosage of Troponin T Hypersensitive Dosage in a Patient Population Hemodialysis and Peritoneal Dialysis
An observational study of Renal Failure Chronic Requiring Dialysis, run by Nantes University Hospital at 1 site in France.
Trial summary
"Troponin T (TnT) is a component of the contractile apparatus of the striated musculature. Although the function of TnT is the same in all striated muscles found in the heart to form a TNT (cardiac TnT) differing significantly TnT of the skeletal muscles. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure Chronic Requiring Dialysis
- What is being tested?
- Blood collection
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2014to 22 Dec 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing haemodialysis or peritoneal dialysis for more than 3 months
Who may be able to join
- Patient in Hemodialysis and/or peritoneal dialysis for more than 3 months
- Major patient
- Patient who can express his consent
- Collection of the not opposition
- Affiliated to the national insurance scheme
Who cannot join
- Encircled woman
- Patients in poor condition general or whose likely survival does not exceed 6 months
- Patient presenting an evolutionary acute pathology or a neoplastic disease
- Patient with significant cardiac problems
- Rhabdomyolysis known muscular disease and active
- Patient presenting an unchecked active infection,HIV
Show all 10Show fewer
- Patient included in another protocol of search which could interfere with the objectives of this study
- Patient psychiatric or incapable to give an informed consent or to pursue the study.
- Minor Patient
- Under guardianship patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment the Dosage of Troponin T Hypersensitive Dosage in a Patient Population Hemodialysis and Peritoneal Dialysis (ECHOTnT)
"Troponin T (TnT) is a component of the contractile apparatus of the striated musculature. Although the function of TnT is the same in all striated muscles found in the heart to form a TNT (cardiac TnT) differing significantly TnT of the skeletal muscles. Because of its high tissue specificity, cardiac TnT is a specific marker and highly sensitive of myocardial injury.
Asymptomatic elevations of troponins is frequently found in patients with chronic renal failure in stage V, which present no clinical signs of acute or electrical myocardial injury.
Read more
Many studies have been conducted in recent years to explain the origin and clinical significance of this elevation, but the results are controversial: cardiac dysfunction, left ventricular hypertrophy or chronic inflammation.
Besides the effect of the dialysis session was evaluated on this biological parameter in different studies which together do not find Impact hemodialysis session on the value of troponin Achieving dosages rate hypersensitive serum troponin T in a dialysis population, will:
- to determine the evolution of TnT in time and what are the characteristics of the patients for whom this rate varies
- to know what its evolution during the session,
- to identify if possible the criteria that are responsible for the variation in the direction of increasing and / or its reduction
- and to characterize patients whose base rate is higher than the 99 percentile in the absence of clinical symptoms which could lead to establish reference population for this specific normal values. The Purpose of this study is to evaluate the serum troponin T in a hypersensitive dialysis population and verify what is the influence of the hemodialysis session, the session parameters and intradialytic events on changes in serum troponin T hypersensitive after a hemodialysis session. "
Read the detailed description
Current care study, single-center, uncontrolled, no randomised, open and prospective.
Two hundred fifty patients on hemodialysis and / or peritoneal dialysis for more than 3 months may be included in the study for a total period of 7 months.
Hemodialysis patients will be informed at the weekly routine visits. Regarding peritoneal dialysis patients, a meeting can be organized with the physician. And the oral agreement of the patient will be collected during a second visit or meeting.
The protocol provides four follow-up visits: at baseline, 4 weeks, 12 and 24 weeks.
During these visits, the patient will have a clinical examination and a measure of the serum troponin T. Blood samples are realized in the usual conditions of the center - for hemodialysis patients: midweek as instructed by the usual protocol of the center. - for peritoneal dialysis patients: when the monthly routine consultation.
- Conditions
- Renal Failure Chronic Requiring Dialysis
- Being tested
- Blood collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess serum troponin T in a hypersensitive dialysis population
Assessment of serum troponin T hypersensitive measured just before the second dialysis week (at the time of inclusion).
Measured: At the time of the inclusion
Secondary outcomes (5)
To estimate the influence of the session of haemodialysis
For the patients in haemodialysis, measures of the serum troponin before and after dialysis
Measured: At the time of the inclusion
To estimate the evolution of the serum Troponin T
measures of the serum troponin T before dialysis
Measured: At the time of the inclusion, at 4 weeks, at 12 weeks and at 24 weeks
To compare the measures of serum troponin T between the patients diabetics and the patients not diabetics, between the patients with cardiac histories and the patients without histories
Clinical questionnaire
Measured: At the time of the inclusion
To compare the evolution of the measures of the serum Troponin T between the patients having undergone one cardiac event and the patients not having presented cardiac events
Clinical questionnaire
Measured: At the time of the inclusion, at 4 weeks, at 12 weeks and at 24 weeks
To compare the measures of the serum Troponin T according to the technique of dialysis: Hemodialysis versus peritoneal dialysis.
Clinical questionnaire
Measured: At the time of the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2015 (estimated)
- Study startJun 2014
- Primary completionMay 2015
- Study completion22 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure Chronic Requiring DialysisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02446639
- Sponsor's protocol ID
- RC13_0056
- Acronym
- ECHOTnT
- Status last verified
- May 2017
- First submitted
- 28 Apr 2015
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment the Dosage of Troponin T Hypersensitive Dosage in a Patient Population Hemodialysis and Peritoneal Dialysis (ECHOTnT)
- ClinicalTrials.gov ID
- NCT02446639
- Acronym / sponsor ID
- ECHOTnT / RC13_0056
- Conditions
- Renal Failure Chronic Requiring Dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2015 (actual)
- Study completion
- 22 Dec 2016 (actual)
- First posted
- 18 May 2015 (estimated)
- 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.
"Troponin T (TnT) is a component of the contractile apparatus of the striated musculature. Although the function of TnT is the same in all striated muscles found in the heart to form a TNT (cardiac TnT) differing significantly TnT of the skeletal muscles. Because of its high tissue specificity, cardiac TnT is a specific marker and highly sensitive of myocardial injury.
Asymptomatic elevations of troponins is frequently found in patients with chronic renal failure in stage V, which present no clinical signs of acute or electrical myocardial injury.
Many studies have been conducted in recent years to explain the origin and clinical significance of this elevation, but the results are controversial: cardiac dysfunction, left ventricular hypertrophy or chronic inflammation.
Besides the effect of the dialysis session was evaluated on this biological parameter in different studies which together do not find Impact hemodialysis session on the value of troponin Achieving dosages rate hypersensitive serum troponin T in a dialysis population, will:
- to determine the evolution of TnT in time and what are the characteristics of the patients for whom this rate varies
- to know what its evolution during the session,
- to identify if possible the criteria that are responsible for the variation in the direction of increasing and / or its reduction
- and to characterize patients whose base rate is higher than the 99 percentile in the absence of clinical symptoms which could lead to establish reference population for this specific normal values. The Purpose of this study is to evaluate the serum troponin T in a hypersensitive dialysis population and verify what is the influence of the hemodialysis session, the session parameters and intradialytic events on changes in serum troponin T hypersensitive after a hemodialysis session. "
Detailed description
Current care study, single-center, uncontrolled, no randomised, open and prospective.
Two hundred fifty patients on hemodialysis and / or peritoneal dialysis for more than 3 months may be included in the study for a total period of 7 months.
Hemodialysis patients will be informed at the weekly routine visits. Regarding peritoneal dialysis patients, a meeting can be organized with the physician. And the oral agreement of the patient will be collected during a second visit or meeting.
The protocol provides four follow-up visits: at baseline, 4 weeks, 12 and 24 weeks.
During these visits, the patient will have a clinical examination and a measure of the serum troponin T. Blood samples are realized in the usual conditions of the center - for hemodialysis patients: midweek as instructed by the usual protocol of the center. - for peritoneal dialysis patients: when the monthly routine consultation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing haemodialysis or peritoneal dialysis for more than 3 months
Key inclusion criteria (5 listed)
- Patient in Hemodialysis and/or peritoneal dialysis for more than 3 months
- Major patient
- Patient who can express his consent
- Collection of the not opposition
- Affiliated to the national insurance scheme
Key exclusion criteria (10 listed)
- Encircled woman
- Patients in poor condition general or whose likely survival does not exceed 6 months
- Patient presenting an evolutionary acute pathology or a neoplastic disease
- Patient with significant cardiac problems
- Rhabdomyolysis known muscular disease and active
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collection | Other | – |
Primary outcome
To assess serum troponin T in a hypersensitive dialysis population
Time frame: At the time of the inclusion
Assessment of serum troponin T hypersensitive measured just before the second dialysis week (at the time of inclusion).
5 secondary outcomes
To estimate the influence of the session of haemodialysis
Time frame: At the time of the inclusion
To estimate the evolution of the serum Troponin T
Time frame: At the time of the inclusion, at 4 weeks, at 12 weeks and at 24 weeks
To compare the measures of serum troponin T between the patients diabetics and the patients not diabetics, between the patients with cardiac histories and the patients without histories
Time frame: At the time of the inclusion
To compare the evolution of the measures of the serum Troponin T between the patients having undergone one cardiac event and the patients not having presented cardiac events
Time frame: At the time of the inclusion, at 4 weeks, at 12 weeks and at 24 weeks
To compare the measures of the serum Troponin T according to the technique of dialysis: Hemodialysis versus peritoneal dialysis.
Time frame: At the time of the inclusion
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 23 May 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Renal Failure Chronic Requiring Dialysis, run by Nantes University Hospital 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 5 inclusion and 10 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 23 May 2017. 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?
To assess serum troponin T in a hypersensitive dialysis population (time frame: At the time of the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2017.