Intravenous Norepinephrine for Orthostatic Hypotension

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT01285908
First received: January 25, 2011
Last updated: September 23, 2014
Last verified: September 2014
Results First Received: September 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Orthostatic Hypertension
Intervention: Drug: Intravenous Norepinephrine Infusion

  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
Subjects were recruited through a NIH/NINDS screening protocol for Primary Chronic Autonomic Failure. Six subjects were enrolled during June 2011 to January 2012. Inclusion criteria required a confirmed diagnosis of neurogenic orthostatic hypotension related to Parkinson disease or pure autonomic failure.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects underwent history and physical exam following consent. Subjects not meeting eligibility criteria were excluded prior to baseline testing. One subject was excluded prior to baseline testing due to recent stroke and one subject was terminated from the study during the testing phase due to examiner's inability to place an arterial line.

Reporting Groups
  Description
Baseline Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees). Baseline measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
Saline, Then Norepinephrine Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees) under two separate conditions, i.e., first following IV administration of saline followed by IV administration of norepinephrine. Measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
Norepinephrine, Then Saline Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees) under two separate conditions, i.e., first following IV administration of norepinephrine followed by IV administration of saline. Measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.

Participant Flow for 2 periods

Period 1:   Baseline Measurement
    Baseline     Saline, Then Norepinephrine     Norepinephrine, Then Saline  
STARTED     6     0     0  
COMPLETED     3     0     0  
NOT COMPLETED     3     0     0  
unable to insert catheter                 1                 0                 0  
History of stroke, exclusion criteria                 1                 0                 0  
unable to tolerate procedure                 1                 0                 0  

Period 2:   Treatment Crossover
    Baseline     Saline, Then Norepinephrine     Norepinephrine, Then Saline  
STARTED     0     2 [1]   2  
COMPLETED     0     2     2  
NOT COMPLETED     0     0     0  
[1] One subject in treatment crossover did not complete baseline testing as unable to complete tasks



  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.
Baseline characteristics are included for all subjects meeting eligibility criteria.

Reporting Groups
  Description
All Study Participants The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or Pure Autonomic Failure.

Baseline Measures
    All Study Participants  
Number of Participants  
[units: participants]
  5  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     3  
Age  
[units: years]
Mean ± Standard Deviation
  65  ± 4  
Gender  
[units: participants]
 
Female     2  
Male     3  
Region of Enrollment  
[units: participants]
 
United States     5  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Blood Pressure (Systolic)   [ Time Frame: 2 experimental days ]

2.  Primary:   Blood Pressure (Diastolic)   [ Time Frame: 2 experimental days ]

3.  Primary:   Blood Pressure (Mean)   [ Time Frame: 2 experimental days ]

4.  Secondary:   Heart Rate   [ Time Frame: 2 experimental days ]

5.  Secondary:   Cardiac Stroke Volume   [ Time Frame: 2 experimental days ]

6.  Secondary:   Cardiac Output   [ Time Frame: 2 experimental days ]

7.  Secondary:   Total Peripheral Resistance   [ Time Frame: 2 experimental days ]

8.  Secondary:   Arterial Plasma Levels of Norepinephrine   [ Time Frame: 2 experimental days ]

9.  Secondary:   Arterial Plasma Levels of Dihydroxyphenylglycol (DHPG)   [ Time Frame: 2 experimental days ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. David S. Goldstein
Organization: National Institute of Neurological Disorders & Stroke
e-mail: david.goldstein1@nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT01285908     History of Changes
Other Study ID Numbers: 110085, 11-N-0085
Study First Received: January 25, 2011
Results First Received: September 24, 2013
Last Updated: September 23, 2014
Health Authority: United States: Federal Government