Trial Outcomes & Findings for Intravenous Norepinephrine for Orthostatic Hypotension (NCT NCT01285908)
NCT ID: NCT01285908
Last Updated: 2014-10-10
Results Overview
The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in systolic pressure at varying tilt angles during baseline and saline infusion.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
6 participants
Primary outcome timeframe
2 experimental days
Results posted on
2014-10-10
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|
|
Baseline Measurement
STARTED
|
6
|
0
|
0
|
|
Baseline Measurement
COMPLETED
|
3
|
0
|
0
|
|
Baseline Measurement
NOT COMPLETED
|
3
|
0
|
0
|
|
Treatment Crossover
STARTED
|
0
|
2
|
2
|
|
Treatment Crossover
COMPLETED
|
0
|
2
|
2
|
|
Treatment Crossover
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|
|
Baseline Measurement
unable to insert catheter
|
1
|
0
|
0
|
|
Baseline Measurement
History of stroke, exclusion criteria
|
1
|
0
|
0
|
|
Baseline Measurement
unable to tolerate procedure
|
1
|
0
|
0
|
Baseline Characteristics
Intravenous Norepinephrine for Orthostatic Hypotension
Baseline characteristics by cohort
| Measure |
All Study Participants
n=5 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or Pure Autonomic Failure.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 4 • n=93 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 2 experimental daysPopulation: One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.
The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in systolic pressure at varying tilt angles during baseline and saline infusion.
Outcome measures
| Measure |
Baseline
n=3 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
|
Saline
n=2 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
|
Norepinephrine
n=4 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
|
|---|---|---|---|
|
Blood Pressure (Systolic)
Tilt Angle 0
|
156 mm Hg
Standard Deviation 15 • Interval 141.0 to 171.0
|
158 mm Hg
Standard Deviation 16 • Interval 142.0 to 174.0
|
179 mm Hg
Standard Deviation 14 • Interval 165.0 to 193.0
|
|
Blood Pressure (Systolic)
Tilt Angle 20
|
148 mm Hg
Standard Deviation 11 • Interval 137.0 to 159.0
|
149 mm Hg
Standard Deviation 9 • Interval 140.0 to 158.0
|
173 mm Hg
Standard Deviation 10 • Interval 163.0 to 183.0
|
|
Blood Pressure (Systolic)
Tilt Angle 40
|
131 mm Hg
Standard Deviation 48 • Interval 83.0 to 179.0
|
128 mm Hg
Standard Deviation 4 • Interval 124.0 to 132.0
|
167 mm Hg
Standard Deviation 11 • Interval 156.0 to 178.0
|
|
Blood Pressure (Systolic)
Tilt Angle 60
|
112 mm Hg
Standard Deviation 3 • Interval 109.0 to 115.0
|
120 mm Hg
Standard Deviation 3 • Interval 117.0 to 123.0
|
175 mm Hg
Standard Deviation 15 • Interval 160.0 to 190.0
|
PRIMARY outcome
Timeframe: 2 experimental daysPopulation: One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.
The extent to which norepinephrine infusion maintains blood pressure, by comparison with the changes in diastolic pressure at varying tilt angles during baseline and saline infusion.
Outcome measures
| Measure |
Baseline
n=3 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
|
Saline
n=2 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
|
Norepinephrine
n=4 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
|
|---|---|---|---|
|
Blood Pressure (Diastolic)
Tilt Angle 0
|
83 mm Hg
Standard Deviation 7 • Interval 76.0 to 90.0
|
83 mm Hg
Standard Deviation 2 • Interval 81.0 to 85.0
|
95 mm Hg
Standard Deviation 6 • Interval 89.0 to 101.0
|
|
Blood Pressure (Diastolic)
Tilt Angle 20
|
85 mm Hg
Standard Deviation 6 • Interval 79.0 to 91.0
|
84 mm Hg
Standard Deviation 3 • Interval 81.0 to 87.0
|
95 mm Hg
Standard Deviation 4 • Interval 91.0 to 99.0
|
|
Blood Pressure (Diastolic)
Tilt Angle 40
|
79 mm Hg
Standard Deviation 4 • Interval 83.0 to 179.0
|
81 mm Hg
Standard Deviation 4 • Interval 124.0 to 132.0
|
92 mm Hg
Standard Deviation 5 • Interval 156.0 to 178.0
|
|
Blood Pressure (Diastolic)
Tilt Angle 60
|
73 mm Hg
Standard Deviation 3 • Interval 109.0 to 115.0
|
80 mm Hg
Standard Deviation 4 • Interval 117.0 to 123.0
|
98 mm Hg
Standard Deviation 7 • Interval 160.0 to 190.0
|
PRIMARY outcome
Timeframe: 2 experimental daysPopulation: One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.
The extent to which norepinephrine infusion maintains average blood pressure, by comparison with the fractional changes in blood pressure at varying tilt angles during baseline and saline infusion.
Outcome measures
| Measure |
Baseline
n=3 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
|
Saline
n=2 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
|
Norepinephrine
n=4 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
|
|---|---|---|---|
|
Blood Pressure (Mean)
Tilt Angle 0
|
107 mm Hg
Standard Deviation 10
|
108 mm Hg
Standard Deviation 7
|
123 mm Hg
Standard Deviation 9
|
|
Blood Pressure (Mean)
Tilt Angle 20
|
106 mm Hg
Standard Deviation 8
|
106 mm Hg
Standard Deviation 5
|
121 mm Hg
Standard Deviation 6
|
|
Blood Pressure (Mean)
Tilt Angle 40
|
96 mm Hg
Standard Deviation 45
|
97 mm Hg
Standard Deviation 4
|
116 mm Hg
Standard Deviation 7
|
|
Blood Pressure (Mean)
Tilt Angle 60
|
86 mm Hg
Standard Deviation 3
|
93 mm Hg
Standard Deviation 3
|
124 mm Hg
Standard Deviation 9
|
SECONDARY outcome
Timeframe: 2 experimental daysPopulation: One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.
The extent to which norepinephrine infusion affects heart rate, by comparison of beat-to-beat heart rate at varying tilt angles during baseline and saline infusion.
Outcome measures
| Measure |
Baseline
n=3 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
|
Saline
n=2 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
|
Norepinephrine
n=4 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
|
|---|---|---|---|
|
Heart Rate
Tilt Angle 0
|
62 bpm
Standard Deviation 4 • Interval 58.0 to 66.0
|
55 bpm
Standard Deviation 8 • Interval 47.0 to 63.0
|
58 bpm
Standard Deviation 5 • Interval 53.0 to 63.0
|
|
Heart Rate
Tilt Angle 20
|
57 bpm
Standard Deviation 2 • Interval 55.0 to 59.0
|
56 bpm
Standard Deviation 3 • Interval 53.0 to 59.0
|
60 bpm
Standard Deviation 4 • Interval 56.0 to 64.0
|
|
Heart Rate
Tilt Angle 40
|
55 bpm
Standard Deviation 3 • Interval 52.0 to 58.0
|
58 bpm
Standard Deviation 3 • Interval 55.0 to 61.0
|
59 bpm
Standard Deviation 4 • Interval 55.0 to 63.0
|
|
Heart Rate
Tilt Angle 60
|
65 bpm
Standard Deviation 3 • Interval 62.0 to 68.0
|
63 bpm
Standard Deviation 4 • Interval 59.0 to 67.0
|
63 bpm
Standard Deviation 2 • Interval 61.0 to 65.0
|
SECONDARY outcome
Timeframe: 2 experimental daysPopulation: One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.
The extent to which norepinephrine infusion affects cardiac stroke volume, by comparison of cardiac stroke volume at varying tilt angles during baseline and saline infusion.
Outcome measures
| Measure |
Baseline
n=3 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
|
Saline
n=2 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
|
Norepinephrine
n=4 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
|
|---|---|---|---|
|
Cardiac Stroke Volume
Tilt Angle 0
|
76 mL
Standard Deviation 15
|
66 mL
Standard Deviation 20
|
83 mL
Standard Deviation 13
|
|
Cardiac Stroke Volume
Tilt Angle 20
|
70 mL
Standard Deviation 15
|
62 mL
Standard Deviation 20
|
82 mL
Standard Deviation 13
|
|
Cardiac Stroke Volume
Tilt Angle 40
|
62 mL
Standard Deviation 13
|
56 mL
Standard Deviation 18
|
76 mL
Standard Deviation 11
|
|
Cardiac Stroke Volume
Tilt Angle 60
|
52 mL
Standard Deviation 5
|
50 mL
Standard Deviation 14
|
67 mL
Standard Deviation 12
|
SECONDARY outcome
Timeframe: 2 experimental daysPopulation: One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.
The extent to which norepinephrine infusion affects cardiac output, by comparison of cardiac output at varying tilt angles during baseline and saline infusion.
Outcome measures
| Measure |
Baseline
n=3 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
|
Saline
n=2 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
|
Norepinephrine
n=4 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
|
|---|---|---|---|
|
Cardiac Output
Tilt Angle 0
|
4.6 L/min
Standard Deviation 0.6
|
3.8 L/min
Standard Deviation 1.6
|
4.9 L/min
Standard Deviation 1.0
|
|
Cardiac Output
Tilt Angle 20
|
3.9 L/min
Standard Deviation 0.7
|
3.5 L/min
Standard Deviation 1.3
|
5.1 L/min
Standard Deviation 1.0
|
|
Cardiac Output
Tilt Angle 40
|
3.4 L/min
Standard Deviation 0.5
|
3.3 L/min
Standard Deviation 1.2
|
4.6 L/min
Standard Deviation 0.9
|
|
Cardiac Output
Tilt Angle 60
|
3.4 L/min
Standard Deviation 0.4
|
3.2 L/min
Standard Deviation 1.1
|
4.2 L/min
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 2 experimental daysPopulation: One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.
The extent to which norepinephrine infusion affected total peripheral resistance, by comparison of total peripheral resistance at varying tilt angles during baseline and saline infusion.
Outcome measures
| Measure |
Baseline
n=3 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
|
Saline
n=2 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
|
Norepinephrine
n=4 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
|
|---|---|---|---|
|
Total Peripheral Resistance
Tilt Angle 0
|
22.4 mmHg/(min/L)
Standard Deviation 1.6 • Interval 20.8 to 24.0
|
34 mmHg/(min/L)
Standard Deviation 16 • Interval 18.0 to 50.0
|
27 mmHg/(min/L)
Standard Deviation 6 • Interval 21.0 to 33.0
|
|
Total Peripheral Resistance
Tilt Angle 20
|
26.9 mmHg/(min/L)
Standard Deviation 3.1 • Interval 23.8 to 30.0
|
33 mmHg/(min/L)
Standard Deviation 14 • Interval 19.0 to 47.0
|
26 mmHg/(min/L)
Standard Deviation 7 • Interval 19.0 to 33.0
|
|
Total Peripheral Resistance
Tilt Angle 40
|
27.7 mmHg/(min/L)
Standard Deviation 3.5 • Interval 24.2 to 31.2
|
32 mmHg/(min/L)
Standard Deviation 13 • Interval 19.0 to 45.0
|
28 mmHg/(min/L)
Standard Deviation 7 • Interval 21.0 to 35.0
|
|
Total Peripheral Resistance
Tilt Angle 60
|
24.5 mmHg/(min/L)
Standard Deviation 2.8 • Interval 21.7 to 27.3
|
30 mmHg/(min/L)
Standard Deviation 9 • Interval 21.0 to 39.0
|
31 mmHg/(min/L)
Standard Deviation 6 • Interval 25.0 to 37.0
|
SECONDARY outcome
Timeframe: 2 experimental daysPopulation: One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.
Plasma levels of norepinephrine are obtained from blood samples via IV catheter.
Outcome measures
| Measure |
Baseline
n=3 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
|
Saline
n=2 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
|
Norepinephrine
n=4 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
|
|---|---|---|---|
|
Arterial Plasma Levels of Norepinephrine
Tilt Angle 20
|
0.89 nmol/L
Standard Deviation 0.34 • Interval 0.55 to 1.23
|
0.65 nmol/L
Standard Deviation 0.22 • Interval 0.43 to 0.87
|
1.99 nmol/L
Standard Deviation 0.67 • Interval 1.32 to 2.66
|
|
Arterial Plasma Levels of Norepinephrine
Tilt Angle 40
|
1.04 nmol/L
Standard Deviation 0.4 • Interval 0.64 to 1.44
|
0.97 nmol/L
Standard Deviation 0.39 • Interval 0.58 to 1.36
|
3.73 nmol/L
Standard Deviation 0.94 • Interval 2.79 to 4.67
|
|
Arterial Plasma Levels of Norepinephrine
Tilt Angle 0
|
0.78 nmol/L
Standard Deviation 0.29 • Interval 0.49 to 1.07
|
0.82 nmol/L
Standard Deviation 0.33 • Interval 0.49 to 1.15
|
0.73 nmol/L
Standard Deviation 0.22 • Interval 0.51 to 0.95
|
|
Arterial Plasma Levels of Norepinephrine
Tilt Angle 60
|
1.3 nmol/L
Standard Deviation 0.48 • Interval 0.82 to 1.78
|
2.32 nmol/L
Standard Deviation 0.02 • Interval 2.3 to 2.34
|
7.83 nmol/L
Standard Deviation 1.4 • Interval 6.43 to 9.23
|
SECONDARY outcome
Timeframe: 2 experimental daysPopulation: One subject was unable to tolerate tilting to 60 degrees following saline infusion and one subject was unable to tolerate tilting to 40 degrees following saline infusion; therefore the data for these subjects was not included in the saline condition.
Plasma levels of dihydroxyphenylglycol are obtained from blood samples via IV catheter.
Outcome measures
| Measure |
Baseline
n=3 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
|
Saline
n=2 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
|
Norepinephrine
n=4 Participants
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
|
|---|---|---|---|
|
Arterial Plasma Levels of Dihydroxyphenylglycol (DHPG)
Tilt Angle 20
|
3.44 nmol/L
Standard Deviation 0.22
|
3.97 nmol/L
Standard Deviation 0.28
|
4.05 nmol/L
Standard Deviation 0.34
|
|
Arterial Plasma Levels of Dihydroxyphenylglycol (DHPG)
Tilt Angle 0
|
3.42 nmol/L
Standard Deviation 0.26
|
4.01 nmol/L
Standard Deviation 0.32
|
4.07 nmol/L
Standard Deviation 0.40
|
|
Arterial Plasma Levels of Dihydroxyphenylglycol (DHPG)
Tilt Angle 40
|
3.82 nmol/L
Standard Deviation 0.46
|
4.18 nmol/L
Standard Deviation 0.30
|
4.12 nmol/L
Standard Deviation 0.45
|
|
Arterial Plasma Levels of Dihydroxyphenylglycol (DHPG)
Tilt Angle 60
|
4.39 nmol/L
Standard Deviation 0.56
|
5.00 nmol/L
Standard Deviation 0.33
|
4.47 nmol/L
Standard Deviation 0.52
|
Adverse Events
Baseline
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Saline, Then Norepinephrine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Norepinephrine, Then Saline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Baseline
n=6 participants at risk
The participants are patients with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of BP at varying tilt angles.
|
Saline, Then Norepinephrine
n=2 participants at risk
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements taken at varying tilt angles under two separate conditions, i.e., following IV administration of saline, followed by IV administration of norepinephrine.
|
Norepinephrine, Then Saline
n=2 participants at risk
The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements taken at varying tilt angles under two separate conditions, i.e., following IV administration of norepinephrine, followed by IV administration of saline.
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Eccymoses
|
16.7%
1/6 • Number of events 1
|
0.00%
0/2
|
0.00%
0/2
|
Additional Information
Dr. David S. Goldstein
National Institute of Neurological Disorders & Stroke
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place