Assessment the Dosage of Troponin T Hypersensitive Dosage in a Patient Population Hemodialysis and Peritoneal Dialysis (ECHOTnT)

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.

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. "

Study Overview

• Status: Completed
• Conditions: Renal Failure Chronic Requiring Dialysis
• Intervention / Treatment: Other: Blood collection

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• France
  • Rezé, France, 44200
    • Centre ECHO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing haemodialysis or peritoneal dialysis for more than 3 months

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At the time of the inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To estimate the influence of the session of haemodialysis	For the patients in haemodialysis, measures of the serum troponin before and after dialysis	At the time of the inclusion
To estimate the evolution of the serum Troponin T	measures of the serum troponin T before dialysis	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	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	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	At the time of the inclusion

Collaborators and Investigators

• Sponsor: Nantes University Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): December 22, 2016

Study Registration Dates

• First Submitted: April 28, 2015
• First Submitted That Met QC Criteria: May 13, 2015
• First Posted (Estimate): May 18, 2015

Study Record Updates

• Last Update Posted (Actual): May 23, 2017
• Last Update Submitted That Met QC Criteria: May 22, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Hypersensitivity; Kidney Failure, Chronic
• Other Study ID Numbers: RC13_0056

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No