End-stage Renal DiseaseNCT02572466
Study of High Sensitive Troponin-I Level in End-stage Renal Disease Patients Receiving Hemodialysis
An observational study of End-stage Renal Disease, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End-stage Renal Disease
- What is being tested?
- Hemodialysis
- How many people
- 207 participants
- Where
- 1 siteThailand
- Study dates
- Feb 2015to Nov 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- End-stage Renal Disease
- Being tested
- Hemodialysis
- Keywords
- high-sensitive troponin-I, End-stage renal disease, hemodialysis
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemodialysisOther
ESRD group received long-term hemodialysis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Hemodialysis | |
| Control group | 1. Aged 18 years or older. 2. without kidney disease (eGFR > 60 ml/min/1.73m2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Sensitive Troponin-I in ESRD group vs Control group
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.
Measured: 10 months
Secondary outcomes (1)
High Sensitive Troponin-I in pre-hemodialysis vs post-hemodialysis
Measure the High Sensitive Troponin-I level before the hemodialysis session comparing to the level after the hemodialysis session.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startFeb 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khajohn Tiranathanagul, Chulalongkorn University
- Investigators
- Khajohn Tiranathanagul, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572466
- Sponsor's protocol ID
- 271/57
- Status last verified
- Jan 2016
- First submitted
- 7 Oct 2015
- Last updated
- 29 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of High Sensitive Troponin-I Level in End-stage Renal Disease Patients Receiving Hemodialysis
- ClinicalTrials.gov ID
- NCT02572466
- Acronym / sponsor ID
- 271/57
- Conditions
- End-stage Renal Disease
- Keywords
- high-sensitive troponin-I, End-stage renal disease, hemodialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Oct 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESRD group | – | Other: Hemodialysis1. 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. |
| Control group | – | –1. Aged 18 years or older. 2. without kidney disease (eGFR > 60 ml/min/1.73m2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| HemodialysisESRD group received long-term hemodialysis | Other | ESRD group |
Primary outcome
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.
1 secondary outcome
High Sensitive Troponin-I in pre-hemodialysis vs post-hemodialysis
Time frame: 4 hours
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 29 Jan 2016.
- Individual participant dataSharing planned: No
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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.
Khajohn Tiranathanagul, MD principal investigator
Chulalongkorn University
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 End-stage Renal Disease, run by Chulalongkorn University at 1 site in Thailand.
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 6 inclusion and 3 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 29 Jan 2016. 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 Thailand. 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?
High Sensitive Troponin-I in ESRD group vs Control group (time frame: 10 months). 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 29 Jan 2016.