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

NCT02572466 | Completed

• 1 other identifier: 271/57
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

End-stage Renal Disease

Keywords

high-sensitive troponin-I; End-stage renal disease; hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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.

  10 months

Secondary Outcomes (1)

• High Sensitive Troponin-I in pre-hemodialysis vs post-hemodialysis

  4 hours

Study Arms (2)

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

Control group

1. Aged 18 years or older. 2. without kidney disease (eGFR \> 60 ml/min/1.73m2)

Interventions

Hemodialysis OTHER

ESRD group received long-term hemodialysis

ESRD group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

King Chulalongkorn Memorial Hospital

Bangkok, Bangkok, 10330, Thailand

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sample

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Study Officials

• Khajohn Tiranathanagul, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 9, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 29, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)