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Evaluation of Sertraline effect for Intradialytic Hypotensionin in the dialytic patients that has been referred to dialyse department of Kowsar hospital in Semnan

Evaluation of Sertraline effect for Intradialytic Hypotensionin in the dialytic patients that has been referred to dialyse department of Kowsar hospital in Semnan

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017080625732N23
Enrollment
100
Registered
2017-08-15
Start date
2017-01-04
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

hypotension. Hypotension, unspecified

Interventions

Intervention 1: Intervention group: receive sertraline 50 mg daily (manufactured by Hayan Darou Company) in during first week and it is increased to 100 mg daily and patients are received sertraline 1
Treatment - Drugs
Placebo
Intervention group: receive sertraline 50 mg daily (manufactured by Hayan Darou Company) in during first week and it is increased to 100 mg daily and patients are received sertraline 100 mg daily for
Control group: receive one placebo tablet daily (totally like sertraline but without therapeutic properties) for 4 weeks.

Sponsors

Semnan University of Medical Sciences, Deputy of Research and Technology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion criteria: Permanent hemodialysis patients for the at least 3 months that in at least 50 percent of their hemodialysis cases in last 3 months, having intra-dialytic hypotension; perform at least 4 hours hemodialysis for 3 times per week; concentration of dialysis fluid: Na: 106 mEq/L, Ca: 5.2 mEq/L, K: 2 mEq/L and mg: 1 mEq/L, Cl: 111.5 mEq/L, HCO3 3.35; fluid dialysis flow: 500 to 600 ml/min; blood flow: 250 to 300 ml/min; antihypertensive agents received during dialysis; available for at least 8 weeks (study time). Exclusion criteria: Performing hemodialysis in different treatment centers during the time of the study; having mental illness that use the SSRIs drug.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Serum creatinine level. Timepoint: Before, 12, 24 and 48 hours after intervention. Method of measurement: Exam.;Blood Urea Nitrogen (BUN). Timepoint: Before, 12, 24 and 48 hours after intervention. Method of measurement: Exam.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaliheh Yarmohammadi

Semnan University of Medical Sciences

are20935@gmail.com+98 23 3345 1336

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 12, 2026