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

SertraLine Administration to prevent inTrAdialytic hypotensioN: A randomized, double-blinded, placebo-controlled, crossover study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20181002002
Enrollment
40
Registered
2018-10-02
Start date
2018-07-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis patients who have history of intradialytic hypotension Intradialytic hypotension Chronic hemodialysis Sertraline Hemodialysis complication

Interventions

Sertraline will be started at the dose of 50 mg/day (1 tablet once daily) during the first week and will be increased to the 100 mg/day (1 tablet twice daily) from week 2 to week 4.,Matching placebo w
Experimental Drug,Placebo Comparator Drug
Sertraline,Placebo

Sponsors

Renal Division, Department of Internal Medicine, Faculty of Medicine, Chiang Mai University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Intradialytic hypotension 4 weeks Defined according to Kidney Disease Outcome Quality Initiative (KDOQI) Guideline 2005

Secondary

MeasureTime frame
N/A N/A N/A,N/A N/A N/A

Countries

Thailand

Contacts

Public ContactKajohnsak Noppakun

Chiang Mai University

kajohnsak.noppakun@cmu.ac.th+66815953465

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026