Healthy Male Subjects Clinical Trial
Official title:
Effect of Sodium Nitroprusside on Cerebral Blood Flow
Verified date | December 2017 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The brain has a high energy demand and requires continuous blood flow. The blood flow to the
brain appears to be unaffected by small changes in blood pressure, but brain blood flow may
be reduced by a large reduction in blood pressure. Large reductions in blood pressure are
common during anesthesia or bleeding. It is unclear, however, how a given reduction in blood
pressure affects blood flow to the brain.
In this study, medicine called sodium nitroprusside is used to dilate blood vessels and
reduce blood pressure in twenty healthy young men. The study will evaluate whether blood flow
to the brain is affected when sodium nitroprusside is used to induce a moderate and a large
reduction in blood pressure. Blood flow to the brain is evaluated using ultrasound on the
neck.
During breathing, oxygen is inhaled and carbon dioxide is exhaled. Carbon dioxide increases
brain blood flow whereby changes in respiration can affect the blood flow to the brain.
Sodium nitroprusside causes mild hyperventilation, whereby more carbon dioxide is exhaled,
which will contribute to a reduction in brain blood flow. Thus, the study will also evaluate
how brain blood flow is affected by hyperventilation and by breathing a mix of air and carbon
dioxide.
Status | Completed |
Enrollment | 20 |
Est. completion date | December 4, 2017 |
Est. primary completion date | December 4, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 35 Years |
Eligibility |
Inclusion Criteria: - Informed consent - Male - Age 18-35 years Exclusion Criteria: - Alcohol intake = 420 g / week - Body mass index below 18 kg/m^2 and above 25 kg/m^2 - Smoking - Beard on the neck - Chronic cardiac, lung, liver, kidney or metabolic disease that require medication - Vitamin B12 deficiency - Anemia - Leber's hereditary optic neuropathy - Tobacco-alcohol amblyopia - Stenosis that obstructs = 16% of the internal carotid artery - Intake of sildenafil or vardenafil for 24 hours and tadalafil for 48 timer prior to the experiment - Intake of monoamine oxidase inhibitors - Neurologic disease considered to affect cerebral blood flow, including epilepsy and multiple sclerosis |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Anesthesia, Rigshospitalet 2043 | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in cerebral blood flow from baseline to when MAP (mean arterial pressure) is decreased by 40% by sodium nitroprusside | Sum of unilateral internal carotid and vertebral artery blood flow [ml/min] by duplex ultrasound corrected for changes in arterial CO2 tension (PaCO2) from baseline | Values are recorded during 2-3 min at 2 time points; at baseline and when MAP is reduced by 40% by sodium nitroprusside (approximately 2 hours after the baseline evaluation) | |
Secondary | Change in cerebral blood flow from baseline to when MAP is decreased by 20% by sodium nitroprusside | Sum of unilateral internal carotid and vertebral artery blood flow [ml/min] by duplex ultrasound corrected for changes in PaCO2 from baseline | Values are recorded during 2-3 min at 2 time points; at baseline and when MAP is reduced by 20% by sodium nitroprusside (approximately 2 hours after the baseline evaluation) | |
Secondary | Relative reduction in internal carotid artery blood flow as compared to that of the vertebral artery from baseline to when MAP is reduced by 40% by sodium nitroprusside | Internal carotid and vertebral artery blood flow [ml/min] by duplex ultrasound corrected for changes in PaCO2 from baseline | Values are recorded during 2-3 min at 2 time points; at baseline and when MAP is reduced by 40% by sodium nitroprusside (approximately 2 hours after the baseline evaluation) | |
Secondary | The CO2 reactivity of the internal carotid as compared to the vertebral artery | The CO2 reactivity of the internal carotid and vertebral arteries as evaluated during baseline, hyperventilation, and 6% CO2 breathing as: change in blood flow *100 / (change in PaCO2 * baseline blood flow). Internal carotid and vertebral artery blood flow [ml/min] by duplex ultrasound and PaCO2 [kilopascal] by arterial gas analysis | Values are recorded during 2-3 min at 3 time points; at baseline, during hyperventilation for 6 min (approx 60 min after the baseline evaluation) and during 6% CO2 breathing for 6 min (approximately 60 min after the baseline evaluation) | |
Secondary | Comparison of the slope of linear regression of MAP and cerebral blood flow for the evaluations at baseline and when MAP is reduced by 20% by sodium nitroprusside and that of the evaluations when MAP is reduced by 20% and 40% | Sum of unilateral internal carotid and vertebral artery blood flow [ml/min] by duplex ultrasound corrected for changes in PaCO2 from baseline and MAP [mmHg] by arterial cannulation | Values are recorded during 2-3 min at 3 time points; at baseline and when MAP is reduced by 20% and 40% by sodium nitroprusside (both approximately 2 hours after the baseline evaluation) |
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