Impact of dialysate calcium concentration on intradialytic left ventricular systolic function: A randomized controlled study

Phase 3

Recruiting

• Conditions: Intradialytic left ventricular fucntion

• Registration Number: TCTR20170623001
• Lead Sponsor: Renal Division, Department of Internal Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-23
• Study Completion: 2018-01-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intradialytic left ventricular systolic function Post hemodialysis Ejection fraction

Secondary Outcome Measures

Name	Time	Method
Intradialytic hypotension before hemodialysis, every 30 minutes during hemodialysis, and 5 minutes after hemodialysis Blood pressure,Fibroblast growth factor-23 month 6 Sandwich ELISA (Merk, USA)