Effects of mineralocorticoid receptor agonist on intradialytic hypotension: an open-label, randomized crossover study

Phase 2

Completed

• Conditions: Intradialytic hypotension; Mineralocorticoid receptor agonist

• Registration Number: TCTR20200128004
• Lead Sponsor: ampang hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-28
• Study Completion: 2020-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

ESRD patients (defined by Kidney Disease Initiative Global Outcome (KDIGO)
Guideline 2012) requiring chronic hemodialysis
- Hemodialysis vintage more than 3 months
- Hemodialysis with 2 sessions per week
- History of intradialytic hypotension at least 30% of their dialysis sessions during the
past 3 months

Exclusion Criteria

- Active cardiac, pulmonary or hepatobiliary tract disease
- Active infection or sepsis
- Systemic fungal infection
- Require ultrafiltration more than 4L per session
- Active malignancy
- Prior treatment with fludocortisone in past 4 weeks
- Contraindication to fludocortisone

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of events of intradilytic hypotension by KDOQI 2002 criteria During hemodialysis Number of events (%) ,Change of Intradialytic blood pressure During hemodialysis mmHg

Secondary Outcome Measures

Name	Time	Method
Intradialytic hemodynamic parameters During hemodialysis Blood pressure (mmHg), heart rate (bpm),Number of events of intradilytic hypotension by KDOQI 2002 criteria During hemodialysis Number of events (%)