Comparison of venlafaxine and midodrine in preventing hypotension due to hemodialysis

Phase 3

Recruiting

• Conditions: Intradialytic hypotension.; Hypotension of hemodialysis; I95.3

• Registration Number: IRCT20151205025372N2
• Lead Sponsor: Oroumia University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 May 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 44

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
adir Mean Arterial Pressure. Timepoint: Dialysis even sessions. Method of measurement: Sphygmomonometer.

Secondary Outcome Measures

Name	Time	Method
adir 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.