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. Identifier: NCT00237770
Recruitment Status : Completed
First Posted : October 12, 2005
Results First Posted : May 19, 2014
Last Update Posted : May 19, 2014
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Hypotension
Spinal Cord Injury
Interventions: Drug: N-Nitro L-arginine-methylester (L-NAME)
Procedure: Head-up Tilt maneuver

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occured from January 2006 through May 2009; participants were recruited from the James J Peters VA Medical Center and the surrounding community.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No subject was excluded after enrollment prior to participation.

Reporting Groups
Tetraplegic Subjects All tetraplegic subjects underwent a head-up tilt maneuver to determine systolic blood pressure responses to placebo L-NAME 1.0 mg/kg and L-NAME 2.0 mg/kg. Subjects with tetraplegia visited the laboratory on 3 separate occasions.
Control Subjects Systolic blood pressure responses to head-up tilt were determined in non-spinal cord injured control subjects following placebo administration. Control subjects visited the laboratory for 1 visit.

Participant Flow:   Overall Study
    Tetraplegic Subjects   Control Subjects
STARTED   9   7 
COMPLETED   9   7 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Individuals With Tetraplegia Systolic blood pressure responses to head-up tilt were determined after placebo, L-NAME (1.0 mg/kg) and L-NAME administration (2.0 mg/kg) administration.
Able-bodied Controls Systolic blood pressure responses to head-up tilt were determined in able-bodied controls following placebo administration
Total Total of all reporting groups

Baseline Measures
   Individuals With Tetraplegia   Able-bodied Controls   Total 
Overall Participants Analyzed 
[Units: Participants]
 9   7   16 
[Units: Participants]
<=18 years   0   0   0 
Between 18 and 65 years   9   7   16 
>=65 years   0   0   0 
[Units: Years]
Mean (Standard Deviation)
 40  (10)   33  (9)   38  (12) 
[Units: Participants]
Female   1   3   4 
Male   8   4   12 
Region of Enrollment 
[Units: Participants]
United States   9   7   16 

  Outcome Measures

1.  Primary:   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. ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The small sample of subjects tested and the heterogeneity of spinal lesions.

  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact:  
Name/Title: Dr. Jill M. Wecht, principal Investigator
Organization: James J Peters VA Medical Center
phone: 718 584-9000 ext 3122

Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: VA Office of Research and Development Identifier: NCT00237770     History of Changes
Other Study ID Numbers: B3600-R
First Submitted: October 7, 2005
First Posted: October 12, 2005
Results First Submitted: September 24, 2013
Results First Posted: May 19, 2014
Last Update Posted: May 19, 2014