Ignite Creation Date:
2024-05-05 @ 11:04 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01247090
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2010-11-22
Brief Title:
Study of the Effect of Intradialytic Vasopressin on Chronic Hypertension in Patients With End Stage Renal Disease
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 015 mU kg-1 min-1 dose of AVP at each dialysis session over a 2-week period the second group will be given AVP 03 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
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 enrollmentextension 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
The data from this study will be used to design and conduct additional study enrollmentextension 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None