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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Vasopressin - Very Low Dose | Active Comparator | 0.15 mU per kg per minute |
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| Group 2: Vasopressin - Low Dose | Active Comparator | 0.30 mU per kg per minute |
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| Group 3: Placebo | Placebo Comparator | No Dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vasopressin - Very Low Dose | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Interdialytic 44-hour Ambulatory Systolic Blood Pressure Over a 2 Week Follow-up Period | This is designed to measure if the administration of intradialytic AVP will result in change in systolic blood pressure. | Baseline and Two Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Anjali Ganda, M.D., M.S. | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Very Low Dose | Very Low Dose: Active Comparator 0.15 mU per kg per minute |
| FG001 | Low Dose | Low Dose: Active Comparator 0.30 mU per kg per minute |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 27, 2016 |
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| Vasopressin - Low Dose | Drug | 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. |
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| Placebo Comparator | Drug | Participants in Group 3 will receive an equal volume of normal saline (placebo) infusion during their standard thrice-weekly dialysis treatments. |
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| FG002 | Placebo | No Dose - Placebo Comparator |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Very Low Dose | Very Low Dose: Active Comparator 0.15 mU per kg per minute |
| BG001 | Low Dose | Low Dose: Active Comparator 0.30 mU per kg per minute |
| BG002 | Placebo | No Dose - Placebo Comparator |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mean Interdialytic 44-hour Ambulatory Systolic Blood Pressure Over a 2 Week Follow-up Period | This is designed to measure if the administration of intradialytic AVP will result in change in systolic blood pressure. | Posted | Mean | Standard Deviation | mm Hg | Baseline and Two Weeks |
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Two weeks.
Method of systematic assessment: Physician assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Very Low Dose | Very Low Dose: Active Comparator 0.15 mU per kg per minute | 0 | 4 | 0 | 4 | 0 | 4 |
| EG001 | Low Dose | Low Dose: Active Comparator 0.30 mU per kg per minute | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Placebo | No Dose - Placebo Comparator | 0 | 4 | 0 | 4 | 0 | 4 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anjali Ganda, MD | Columbia University Medical Center | 617-835-3789 | ag355@columbia.edu |
| Jul 28, 2017 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007676 | Kidney Failure, Chronic |
| D003919 | Diabetes Insipidus |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010900 | Pituitary Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014667 | Vasopressins |
| D001127 | Arginine Vasopressin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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