Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0521099246
Study information
Scientific title
Effects of ethanol on injury-induced changes in cardiovascular control
Acronym
Study hypothesis
The object of the proposed study is to test the following hypotheses
1. Simulated musculo-skeletal injury in normal volunteers will:
1.1. Reduce resting vagal tone to the heart, assessed using heart rate variability
1.2. Attenuate the baroreflex, assessed using the Valsalva ratio
2. The effects of simulated injury listed above will be enhanced in the presence of ethanol (100-200 mg% blood level).
Ethics approval
Not provided at time of registration
Study design
Randomised crossover trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Cardiovascular: Heart rate
Intervention
Each subject will act as his/her own control. Each volunteer will be subjected to the following assessments:
1. Measurements of heart rate, blood pressure and respiratory rate
2. Heart rate variability in the presence and absence of a cold stimulus to the face (normal and enhanced vagal tone to the heart respectively)
3. Valsalva ratio (baroreflex)
These assessments will be made before and during a 20 minute period of limb ischaemia induced by the bilateral application of pneumatic thigh cuffs (to simulate musculo skeletal injury). This will provide pre-injury (control) data followed by the effects of simulated injury. The entire sequence will be performed, on separate occasions on the same subjects, in the presence and absence of ethanol (vodka in orange juice given orally to obtain a blood alcohol level of 100-200 mg%).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The aim of the project is to determine in volunteers whether simulated injury alters the vagal activity to the heart, attenuates the baroreflex and whether these effects are enhanced by clinically relevant levels of ethanol in the blood.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2001
Overall trial end date
30/06/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy male volunteers
Participant type
Patient
Age group
Not Specified
Gender
Male
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2001
Recruitment end date
30/06/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University Hospital of North Durham
Durham
DH1 5TW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
County Durham and Darlington Acute Hospitals NHS Trust (North) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary