Prevention of Low Blood Pressure in Persons With Tetraplegia
|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: NCT00237770|
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : May 19, 2014
Last Update Posted : May 19, 2014
|Condition or disease||Intervention/treatment||Phase|
|Hypotension Spinal Cord Injury||Drug: N-Nitro L-arginine-methylester (L-NAME) Procedure: Head-up Tilt maneuver||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Low Blood Pressure in Persons With Tetraplegia|
|Study Start Date :||June 2003|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Placebo Comparator: Arm 1
Placebo control (normal saline) is employed on a separate visit during procedure.
Drug: N-Nitro L-arginine-methylester (L-NAME)
A non-specific inhibitor of the nitric oxide synthase enzyme.
Procedure: Head-up Tilt maneuver
Participant will be placed onto tilt table and brought to 15 degrees of head up tilt for 60 minutes (intravenous infusion time). After this time, a progressive increase to 45 degrees will be completed with a 10 degree increase every 5 minutes. Participant will remain at 45 degrees for 45 minutes or until symptom onset.
- Systolic Blood Pressure During Head-up Tilt [ Time Frame: Average systolic blood pressure during head-up tilt (45 degrees) comparing active drug (L-NAME: 1.0 and 2.0 mg/kg) to placebo. ]Average systolic blood pressure over 45 minutes at 45 degrees of head-up tilt.
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): NCT00237770
|United States, New York|
|VA Medical Center, Bronx|
|Bronx, New York, United States, 10468|
|Principal Investigator:||William Bauman, MD||VA Medical Center, Bronx|