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Comparison of venlafaxine and midodrine in preventing hypotension due to hemodialysis

Comparison Of The Effect Of Venlafaxine And Midodrine In Preventing Intra-Dialytic Hypotension A Randomized Crossover Study

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20151205025372N2
Enrollment
44
Registered
2019-04-22
Start date
2019-02-16
Completion date
Unknown
Last updated
2019-05-21

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

Conditions

Intradialytic hypotension. Hypotension of hemodialysis

Interventions

Intervention 1: Intervention group: first intervention group for 2 weeks receives 5 mg midodrine half an hour before hemodialysis. Then, after a washout period of one week, for 4 weeks receives venlaf

Sponsors

Oroumia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Informed consent to participate in the study Being on maintenance hemodialysis for at least 3 months Intradialytic hypotension in at least 50% of dialysis sessions in the last month (Intradialytic hypotension definition according to KDOQI: A decrease in systolic blood pressure of 20mmHg or more or 10mmHg in mean arterial pressure that can cause symptoms of intradialytic hypotension including abdominal discomfort, yawning, sighing, nausea vomiting, muscle cramps, agitation, dizziness, fainting, and restlessness.)

Exclusion criteria

Exclusion criteria: History of venlafaxine or midodrine intolerance in previous consumption Severe hepatic failure (Child-Pugh C) Present use of MAOIs or use during the last 2 weeks Present use of linezolid or serotonergic medications History of depression/mania or active psychiatric disease Seizure history or being under treatment for it Any other concomitant disease other than intradialytic hypotension that the patient's hypotension can be attributed to it (such as tamponade, active cancer, PTE, dehydration, bleeding, shock) History of ACS or CAD Not consenting to participate in the study

Design outcomes

Primary

MeasureTime frame
Nadir Mean Arterial Pressure. Timepoint: Dialysis even sessions. Method of measurement: Sphygmomonometer.

Secondary

MeasureTime frame
Nadir systolic blood pressure. Timepoint: Dialysis even sessions. Method of measurement: Sphygmomonometer.;Nadir diastolic blood pressure. Timepoint: Dialysis even sessions. Method of measurement: Sphygmomonometer.;Number of intradialytic hypotension episodes in each group. Timepoint: Dialysis even sessions. Method of measurement: Observation by educated and qualified nurse.;Pre and post dialysis systolic blood pressure difference. Timepoint: Dialysis even sessions. Method of measurement: Sphygmomonometer.;Pre and post dialysis diastolic blood pressure difference. Timepoint: Dialysis even sessions. Method of measurement: Sphygmomonometer.;Pre and post dialysis mean arterial pressure difference. Timepoint: Dialysis even sessions. Method of measurement: Sphygmomonometer.;Frequency of adverse drug reactions in each intervention group. Timepoint: From the start to the end of each medication intervention in each group. Method of measurement: Patient interview.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactZahra Alimohammad Ghelich Khan

Oroumia University of Medical Sciences

z.gkhan@yahoo.com+98 44 3275 4991

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026