Intravenous Norepinephrine for Orthostatic Hypotension
Status:
Completed
Trial end date:
2012-09-01
Target enrollment:
Participant gender:
Summary
Background:
- Orthostatic hypotension is a fall in blood pressure when standing up. Normally, a reflex
action of the automatic nervous system makes blood vessels tighten when people stand up. The
nervous system releases the chemical norepinephrine, which tightens blood vessels and keeps
blood pressure in check. In orthostatic hypotension, the nervous system does not release
enough norepinephrine when a person stands up, which can cause fainting or falling.
Researchers are interested in determining whether norepinephrine given as a drug by vein can
help maintain blood pressure during changes in body position.
Objectives:
- To determine whether intravenous norepinephrine can maintain blood pressure in people with
orthostatic hypotension.
Eligibility:
- Individuals at least 18 years of age who have been diagnosed with orthostatic hypotension
related to Parkinson's disease or pure autonomic failure.
Design:
- This study will require a 2-day inpatient admission to the NIH Clinical Center. The
first day will involve laboratory evaluation and the second day will involve testing
with norepinephrine. The second day requires an overnight stay.
- Participants will be screened with a medical history and physical examination, blood
samples, and an electrocardiogram or echocardiogram.
- Participants who are on medications may be asked to taper or discontinue one or more
medications for the purposes of this study. Participants may not take aspirin or any
drugs that slow blood clotting for 7 days before study participation.
- Day 1: Participants will have a clear liquid breakfast, and will have a 1-hour baseline
tilt table test to monitor blood flow, skin temperature, sweating, and blood pressure.
Body temperature and breathing will also be monitored.
- Day 2: Participants will have a clear liquid breakfast, and will have a 2-hour tilt
table test. Initial blood pressure readings will be taken, and an intravenous line will
be placed. Participants will then receive norepinephrine or saline, followed by
additional position changes of the tilt table to measure blood pressure differences
before returning to the starting position. After about 10 minutes, the tilt table
testing and infusion will be repeated with the other drug (saline or norepinephrine).
- Participants will be discharged 24 hours after the testing is complete.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)