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Study of the Effect of Intradialytic Vasopressin on Chronic Hypertension in Patients With End Stage Renal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01247090
Recruitment Status : Completed
First Posted : November 24, 2010
Results First Posted : April 28, 2011
Last Update Posted : November 18, 2019
Sponsor:
Information provided by (Responsible Party):
Columbia University

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 hemodialysis have high blood pressure, which is poorly controlled in most. Normal blood pressure in these patients greatly improves the chance of living. Increased fluid in the body and bloodstream is a major cause of hypertension in patients with ESRD. Fluid removal during hemodialysis is often limited by symptoms of low blood pressure during the procedure. Therefore the increase in fluid and related high blood pressure is ongoing for many of these patients. Arginine vasopressin (AVP) is a hormone naturally produced by the body which has little effect on blood pressure in healthy people, but acts as a powerful vasoconstrictor (narrows the blood vessels) when blood pressure is threatened. Recent studies have shown when there is too little AVP, patients are more likely to have low blood pressure during dialysis that limits fluid removal, an effect that can be reversed by giving these patients low doses of AVP. This phase II trial will find out which of two doses of AVP (.15 or .30 mU kg-1 min-1), in combination with standard therapy, works best to change interdialytic 44-hour ambulatory systolic blood pressure after 2 weeks. Patients who enroll in this study will be divided into three groups. One group will be given a 0.15 mU kg-1 min-1 dose of AVP at each dialysis session over a 2-week period; the second group will be given AVP 0.3 mU kg-1 min-1 at the same interval; and a third group will be given normal saline (placebo) at the same interval. All patients will be closely monitored for side-effects.

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

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other Names:
  • Vasopressin Injection
  • USP (8-L arginine vasopressin)
  • AVP
  • Pitressin®

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.
Other Names:
  • Vasopressin Injection
  • USP (8-L arginine vasopressin)
  • AVP
  • Pitressin®

Placebo Comparator: Group 3: Placebo
No Dose
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.


Information from the National Library of Medicine

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


Locations
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United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
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Principal Investigator: Anjali Ganda, M.D., M.S. Columbia University
  Study Documents (Full-Text)

Documents provided by Columbia University:
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Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01247090    
Other Study ID Numbers: AAAE0454 - pilot
First Posted: November 24, 2010    Key Record Dates
Results First Posted: April 28, 2011
Last Update Posted: November 18, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Columbia University:
hypertension
end stage renal disease
vasopressin
Arginine Vasopressin
AVP
Pitressin®
Additional relevant MeSH terms:
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Kidney Diseases
Kidney Failure, Chronic
Hypertension
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Vasoconstrictor Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs