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

NCT02446639 | Completed

• 1 other identifier: RC13_0056
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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. "

Conditions

Renal Failure Chronic Requiring Dialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• To estimate the influence of the session of haemodialysis

  At the time of the inclusion

• To estimate the evolution of the serum Troponin T

  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

  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

  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.

  At the time of the inclusion

Interventions

Blood collection OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing haemodialysis or peritoneal dialysis for more than 3 months

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Centre ECHO

Rezé, 44200, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 18, 2015
• Study Start: June 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 22, 2016
• Last Updated: May 23, 2017

Record last verified: 2017-05

Locations

FR (1)