CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
Infusion of sodium nitroprusside +2 moredrug
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03317652
NCT03317652N/ACompleted

Effect of Sodium Nitroprusside on Cerebral Blood Flow

Rigshospitalet, Denmark·interventional·Posted Oct 23, 2017·Updated Dec 8, 2017

In Brief

A clinical study evaluating Hyperventilation, 6% CO2 breathing, and 1 other intervention for Healthy Male Subjects. Completed, enrolled 20 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesDenmark
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 23, 2017
Enrollment StartNov 3, 2017
Primary CompletionDec 4, 2017
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 8.7 years ago

Interventions

Hyperventilationother

The subject is instructed to hyperventilate for 6 min to provoke a 0.7-1.2 kPa reduction in PaCO2, and the evaluation is repeated if the reduction in PaCO2 is not within this interval. The order of hyperventilation and 6% CO2 breathing is randomized.

6% CO2 breathingother

The subject breathes a mixture of 6% CO2 (with 21% O2 and 73% N2) from a bag and a face mask for 6 minutes. The order of hyperventilation and 6% CO2 breathing is randomized.

Infusion of sodium nitroprussidedrug

Using incremental intravenous infusion of sodium nitroprusside MAP is reduced by 20% (15%-25%) and then by 40% (35%-45%, MAP minimally at 50 mmHg).