- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02252627
The Effect of Phenylephrine and Ephedrine on Microvascular Blood Flow
An Observational Study to Test the Effect of the Vasoactive Drugs Phenylephrine and Ephedrine on the Stroke Volume and Microvascular Blood Flow of Healthy Volunteers
During operations to treat abdominal problems the blood pressure can fall, resulting in falls in blood flow to the vital organs. This fall can be treated by the administration of drugs that cause constriction of blood vessels. Although these drugs correct falls in blood pressure, it is unclear what effect they have on blood flow from the heart and to the vital organs.
In this study of healthy volunteers we aim to better understand the changes in blood flow in both small and large vessels that occur in response to administration of these drugs. To do this we will use two different techniques of ultrasound imaging. A narrow (4-5mm) ultrasound probe will be inserted into the oesophagus via a nostril to measure blood flow in a major blood vessel. A second probe will rest on the abdomen and will record changes in blood flow in small vessels of the liver. Two drugs which raise the blood pressure via different mechanisms will be administered and the changes in flow from the heart and to vital organs will be measured and compared.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: John P Williams, PhD
- Email: john.williams7@nhs.net
Study Locations
-
-
Derbyshire
-
Derby, Derbyshire, United Kingdom, DE22 3DT
- Recruiting
- University of Nottingham, School of Medicine, Division of Medical Sciences and Graduate Entry Medicine
-
Contact:
- David Read, BMBS
- Email: dread1@nhs.net
-
Principal Investigator:
- John P Williams, PhD
-
Sub-Investigator:
- Thomas P Heinink, BMBS
-
Sub-Investigator:
- Jonathan N Lund, MD
-
Sub-Investigator:
- Bethan E Phillips, PhD
-
Sub-Investigator:
- David Read, BMBS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Aged 18-60 years
- Male
- Able to consent in English by themselves
- Absence of any exclusion criteria
Exclusion Criteria:
- A BMI < 20 or > 28 kg•m2
- Active cardiovascular disease: uncontrolled hypertension (BP > 140/90), angina, heart failure (class III/IV), arthymia, right to left cardiac shunt or recent cardiac event
- Individuals taking alpha or beta-adrenergic blocking agents, monoamine oxidase inhibitors, tricyclic antidepressants, serotonin or noradrenaline selective reuptake inhibitors, quinidine, cardiac glycosides or buspirone (or who have ceased taking them in the previous 14 days¬)
- Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial)
- Peripheral vascular disease
- Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, types 1 or 2 diabetes
- Active inflammatory bowel disease, or renal disease
- Known prostatic hypertrophy
- Malignancy
- Clotting dysfunction
- Previous oesophageal surgery
- Individuals with a known history of oesophageal varices
- Individuals with a known history of epistaxis
- Family history of early (<55y) death from cardiovascular disease
- Known sensitivity to SonoVue, ephedrine or phenylephrine
- Participants who have taken part in any other research study in the last three months which involved: taking a drug; being paid a disturbance allowance; having an invasive procedure (eg blood sample >50ml, muscle biopsies) or exposure to ionising radiation.
Study Plan
How is the study designed?
Design Details
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group 1
Healthy volunteers
|
Intravenous phenylephrine will be administered in 50-100 microgram increments until the mean arterial blood pressure has increased by 25% compared to baseline, or until a maximum dose of 1mg has been administered.
The measurement of stroke volume will be performed using an Oesophageal Doppler Monitor
Microvascular blood flow will be measured using a contrast enhanced ultrasound scan
Intravenous ephedrine will be administered in 3-6mg increments until the mean arterial blood pressure has increased by 25% compared to baseline, or until a maximum dose of 30mg has been administered.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in microvascular blood flow
Time Frame: 30 minutes
|
Microvascular visceral blood flow is assessed using contrast enhanced ultrasound, and will be assessed before and after the administration of each drug.
|
30 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in stroke volume
Time Frame: 30 mins
|
The change in stroke volume will be assessed using an Oesophageal Doppler Monitor, and will be assessed before and after the administration of each drug.
|
30 mins
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Cardiotonic Agents
- Respiratory System Agents
- Central Nervous System Stimulants
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Nasal Decongestants
- Adrenergic alpha-1 Receptor Agonists
- Ephedrine
- Phenylephrine
- Oxymetazoline
Other Study ID Numbers
- H10102013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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