Study of High Sensitive Troponin-I Level in End-stage Renal Disease Patients Receiving Hemodialysis

January 27, 2016 updated by: Khajohn Tiranathanagul, Chulalongkorn University
This study objective is to compare the high sensitive troponin-I level in end-stage renal disease patients received hemodialysis without acute cardiovascular event with healthy population. The investigators also determine the effect of hemodialysis on troponin I level as the secondary objective.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Human cardiac Troponin I (cTnI) is an composition of Troponin which is found in heart muscle cells. Molecular weight of cTnI is 23,875 Dalton consisting of 209 amino acids. [1,2] The cTnI have been used in the diagnosis of acute myocardial infarction(AMI). [3,4,5] According to ESC / ACCF / AHA / WHF, diagnosis of acute myocardial infarction rely on the data from clinical symptoms, Electrocardiogram (EKG) changes in the specific pattern, such as ST-segment elevation / depression, new left bundle branch block, and cardiac biomarker level rise over the 99th percentile upper reference limit, which makes the cTnI level was used to help in making diagnosis for patient coming with symptoms of angina in emergency room.

The current cTnI detecting test has developed more and more high sensitive(called "high-sensitive troponin-I; hsTnI") which can detected in the range 10-50,000 pg / ml (ng / L) [6], and it can detected cTnI level even in normal people unlike cTnI, which only reported positive or negative or lower than the limit of detection. Due to ARCHITECT stat High sensitive Troponin-I (Abbott diagnostic) capabilities, hsTnI level can be detected in normal people up to 96 percent.[7] The reference range of hsTnI which has been researched by Apple FS, et al.(2012) studying the 19 types of cardiac troponin I and T measurement was established. The 99th percentile values for general healthy population without hypertension, diabetes, kidney disease and myocardial infarction, aged 18-64 years was 36 ng / L in men (N = 272), 15 ng / L in women (N = 252) [7].

However, research to find the reference of hsTnI in some groups , especially in patients with kidney disease is still limited and the diagnosis of acute myocardial infarction also use the 99th percentile as the reference source which was researched in healthy population[7] which makes it difficult to interpret. Sometimes doctors may concluded that patients with rising hsTnI because of kidney disease. According to the research in the next section, there are both support and against in this idea. Therefore, the researchers aim to study hsTnI in patients with end-stage renal disease received hemodialysis compare with normal population.

Study Type

Observational

Enrollment (Actual)

207

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • King Chulalongkorn Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ESRD group End-stage renal disease patients receiving regular hemodialysis at King Chulalongkorn memorial hospital, Bhumirajanagarindra kidney institute hospital.

Control group Patients who come to OPD at King Chulalongkorn memorial hospital for their follow up blood check.

Description

Inclusion Criteria:

  • Aged 18 years or more.
  • was diagnosed as End-stage renal disease for more than one year.
  • Attend hemodialysis 3 times a week consistently for more than 6 months.
  • Hemodialysis with Kt/V > 1.2
  • No urine output or is less than 500 ml per day.
  • No symptoms of myocardial infarction Or were hospitalized with the similar diagnosis during the two weeks.

Exclusion Criteria:

  • Could not complete hemodialysis, or Kt / V <1.2
  • Has symptoms of myocardial infarction while receiving dialysis
  • Has the abnormal symptom (fever, chill, low BP) While receiving dialys

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ESRD group
  1. Aged 18 years or older.
  2. was diagnosed as End-stage renal disease for more than one year.
  3. Attend hemodialysis 3 times a week consistently for more than 6 months.
  4. Hemodialysis with Kt/V > 1.2
  5. No urine output or is less than 500 ml per day.
  6. No symptoms of myocardial infarction Or were hospitalized with the similar diagnosis during the two weeks.
Other: Hemodialysis
ESRD group received long-term hemodialysis
Control group
  1. Aged 18 years or older.
  2. without kidney disease (eGFR > 60 ml/min/1.73m2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High Sensitive Troponin-I in ESRD group vs Control group
Time Frame: 10 months

ESRD group

  • Measure the High Sensitive Troponin-I level before the hemodialysis session Control group
  • Measure the High Sensitive Troponin-I as an additional test to their follow up blood check.
10 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
High Sensitive Troponin-I in pre-hemodialysis vs post-hemodialysis
Time Frame: 4 hours
Measure the High Sensitive Troponin-I level before the hemodialysis session comparing to the level after the hemodialysis session.
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

October 7, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 9, 2015

Study Record Updates

Last Update Posted (Estimate)

January 29, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 271/57

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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