Status:
ACTIVE_NOT_RECRUITING
Hemodialysis.-Induced Hypotension Therapy for End Stage Kidney Disease
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Hemodialysis Complication
Hypotension of Hemodialysis
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
Bradykinin is a potent vasodilator that is formed by the activation of the kallikrein-kinin system. We and others have shown that bradykinin increased during hemodialysis; however, the role of bradyki...
Eligibility Criteria
Inclusion
- Subjects age 18 to 85 years
- On thrice-weekly hemodialysis for at least six months
- Clinically stable, adequately dialyzed (single-pool Kt/V \> 1.2), with polysulphone membrane for at least three consecutive months before the study
- Subjects with pre-dialytic systolic blood pressure between 110 and 170 mmHg.
- Subjects with a reduction of systolic blood pressure during hemodialysis equal to or greater than 30 mmHg, with associated symptoms such as nausea, vomiting, muscle cramps, dizziness, or anxiety.
- Hypotensive episodes should occur four times or more in four weeks (12 hemodialysis sessions).
Exclusion
- Subjects with intradialytic hypotension that require the use of pharmacological intervention such as midodrine or vasopressin
- Subjects with pre-dialytic systolic blood pressure greater than 170 mmHg or diastolic blood pressure greater than 110 mmHg
- History of myocardial infarction or cerebrovascular event within 3 months
- History of serious hemorrhage (including cerebral hemorrhage) in the past 6 months
- Advanced liver disease
- Ejection fraction less than 30%
- Anticipated live donor kidney transplant
- A history of poor adherence to hemodialysis or medical regimen
- Severe anemia (hemoglobin less than 8 g/dl) requiring blood transfusions
- Use of immunosuppressive drugs within one month before study enrollment
- Active connective tissue disease
- History of acute infections disease within one month before study enrollment
- Inability to provide consent
- Pregnancy
Key Trial Info
Start Date :
July 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT05297786
Start Date
July 27 2022
End Date
August 1 2025
Last Update
July 15 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232