Prevention of Low Blood Pressure in Persons With Tetraplegia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00237770
First received: October 7, 2005
Last updated: April 23, 2014
Last verified: April 2014
Results First Received: September 24, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: 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
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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
  Description
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  
NOT COMPLETED     0     0  



  Baseline Characteristics
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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
  Description
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  
Number of Participants  
[units: participants]
  9     7     16  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     7     16  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  40  ± 10     33  ± 9     38  ± 12  
Gender  
[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
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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
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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
e-mail: jm.wecht@va.gov


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00237770     History of Changes
Other Study ID Numbers: B3600-R
Study First Received: October 7, 2005
Results First Received: September 24, 2013
Last Updated: April 23, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration