TCTR20170623001
Recruiting
Phase 3
Impact of dialysate calcium concentration on intradialytic left ventricular systolic function: A randomized controlled study
Renal Division, Department of Internal Medicine, Chiang Mai University0 sites82 target enrollmentJune 23, 2017
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Renal Division, Department of Internal Medicine, Chiang Mai University
- Enrollment
- 82
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age more than 18 years old
- •\- End\-stage renal disease (defined by estimated glomerular filtration rate \<15 ml/min/1\.73 m2 which require long\-term hemodialysis
- •\- Hemodialysis vintage of more than 3 months
- •\- Hemodialysis 3 sessions per week
Exclusion Criteria
- •\- \>2 episodes of intradialytic hypotension which required immediate treatment prior to randomization
- •\- Active cardiac disease (e.g., acute myocardial infarction, heart failure, arrhythmia)
- •\- Sepsis/septic shock
- •\- Require ultrafiltration more than 3\.5 L/session
- •\- Active malignancy
- •\- Documented reduced left ventricular ejection fraction (LVEF \<30%) prior to enrollment
- •\- Documented vascular calcification prior to enrollment
- •\- Hypercalcemia (serum calcium \>10\.5 mg/dl) or hypocalcemia (serum calcium \<7 mg/dl) prior to enrollment
Outcomes
Primary Outcomes
Not specified
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