Status:
COMPLETED
Study of the Effect of Intradialytic Vasopressin on Chronic Hypertension in Patients With End Stage Renal Disease
Lead Sponsor:
Columbia University
Conditions:
Hypertension
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The death rate of patients with endstage renal disease (ESRD) on dialysis each year is 20%, with diseases related to the heart and blood vessels causing about half. About 60% of patients on hemodialys...
Detailed Description
This pilot study originally enrolled a group of 12 subjects (4 subjects per arm) in order to demonstrate feasibility with the primary outcome measure, interdialytic 44-hour ambulatory systolic blood p...
Eligibility Criteria
Inclusion
- End Stage Renal Disease on Hemodialysis greater than 3 months
- Hypertension (Predialysis systolic blood pressure (SBP) greater than 140 mmHg, averaged over preceding 6 dialysis treatments)
- Stable dry weight over preceding 6 dialysis treatments
Exclusion
- Age less than 18 years
- Clinically significant vascular disease\*
- Predialysis systolic blood pressure (SBP) greater than 200 mmHg or diastolic blood pressure (BP) \>110
- Pregnancy
- Long QTc syndrome (an electrocardiogram (ECG) will be performed if unavailable within the last 3 months)
- Clinically significant vascular disease is defined as any of the following occurring in the preceding three months: angina, claudication, transient ischemic attack, myocardial infarction, cerebrovascular accident, or decompensated heart failure. Furthermore, patients will be excluded if they have any history of ischemic colitis or Raynaud's disease.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2018
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT01247090
Start Date
October 1 2010
End Date
August 1 2018
Last Update
November 18 2019
Active Locations (1)
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1
Columbia University Medical Center
New York, New York, United States, 10032