Study of the Effect of Intradialytic Vasopressin on Chronic Hypertension in Patients With End Stage Renal Disease
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|ClinicalTrials.gov Identifier: NCT01247090|
Recruitment Status : Completed
First Posted : November 24, 2010
Results First Posted : April 28, 2011
Last Update Posted : November 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hypertension End Stage Renal Disease||Drug: Vasopressin - Very Low Dose Drug: Vasopressin - Low Dose Drug: Placebo Comparator||Phase 2|
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 pressure. Data on the original subjects is complete and results are posted.
The data from this study will be used to design and conduct additional study enrollment/extension (24 subjects) in order to make some initial statistical comparisons between groups, which will help establish greater confidence in our novel method for controlling blood pressure in dialysis patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Pilot Study of the Effect of Intradialytic Vasopressin Infusion on Chronic Blood Pressure Control in Hypertensive Patients With End Stage Renal Disease: A Program to Develop a Decisive, Randomized Controlled Trial|
|Actual Study Start Date :||October 2010|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
Active Comparator: Group 1: Vasopressin - Very Low Dose
0.15 mU per kg per minute
Drug: Vasopressin - Very Low Dose
Intradialytic vasopressin (AVP) infusion. The dose is calculated based upon the individual's weight in kilograms. A kilogram is equal to 2.2 pounds. For example, a person who weighs 70 kg (or 154 pounds) would receive a dose equal to 0.15 mU * 70 kg, or 10.5 mU of AVP per minute by infusion at their thrice-weekly dialysis treatments.
Active Comparator: Group 2: Vasopressin - Low Dose
0.30 mU per kg per minute
Drug: Vasopressin - Low Dose
Intradialytic vasopressin (AVP) infusion. The dose is calculated based upon the individual's weight in kilograms. A kilogram is equal to 2.2 pounds. For example, a person who weighs 70 kg (or 154 pounds) would receive a dose equal to 0.30 mU * 70 kg, or 21 mU of AVP per minute by infusion at their thrice-weekly dialysis treatments.
Placebo Comparator: Group 3: Placebo
Drug: Placebo Comparator
Participants in Group 3 will receive an equal volume of normal saline (placebo) infusion during their standard thrice-weekly dialysis treatments.
Other Name: Normal saline
- Change in Mean Interdialytic 44-hour Ambulatory Systolic Blood Pressure Over a 2 Week Follow-up Period [ Time Frame: Baseline and Two Weeks ]This is designed to measure if the administration of intradialytic AVP will result in change in systolic blood pressure.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247090
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Anjali Ganda, M.D., M.S.||Columbia University|