Study of the Effect of Intradialytic Vasopressin on Chronic Hypertension in Patients With End Stage Renal Disease
Condition: Hypertension; End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Hypertension
Intervention: Vasopressin - Very Low Dose; Vasopressin - Low Dose; Placebo Comparator
Intervention description: 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.; 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.; Participants in Group 3 will receive an equal volume of normal saline (placebo) infusion during their standard thrice-weekly dialysis treatments.
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hypertension; end stage renal disease; vasopressin; Arginine Vasopressin; AVP; Pitressin®

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.
    

Eligibility 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.