SertraLine administration to prevent intrAdialytic hypotension: A randomized, double-blinded, placebo-controlled, crossover study

Phase 3

Completed

• Conditions: Hemodialysis patients who have history of intradialytic hypotension; Intradialytic hypotension; Chronic hemodialysis; Sertraline; Hemodialysis complication

• Registration Number: TCTR20181002002
• Lead Sponsor: Renal Division, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-02
• Study Completion: 2019-02-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Age of 18 years old or older
2. End-stage renal disease (ESRD) patients (defined by Kidney Disease Initiative Global Outcome (KDIGO) Guideline 2012) requiring chronic hemodialysis
3. Hemodialysis vintage of more than 3 months
4. Hemodialysis with 3 sessions per week
5. History of intradialytic hypotension in at least 25% of their dialysis sessions during the past 2 months

Exclusion Criteria

1. Active cardiac disease
2. Sepsis or septic shock
3. Require ultrafiltration of more than 3.5 L per session
4. Active malignancy
5. Prior treatment with Selective serotonin reuptake inhibitors (SSRIs) in the past 4 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intradialytic hypotension 4 weeks Defined according to Kidney Disease Outcome Quality Initiative (KDOQI) Guideline 2005

Secondary Outcome Measures

Name	Time	Method
/A N/A N/A,N/A N/A N/A