Effects of ethanol on injury-induced changes in cardiovascular control

ISRCTN	ISRCTN65746454
DOI	https://doi.org/10.1186/ISRCTN65746454
Secondary identifying numbers	N0521099246

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 25/03/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr D Thomas
Scientific

University Hospital of North Durham
North Road
Durham
DH1 5TW
United Kingdom

Study information

Study design	Randomised crossover trial
Primary study design	Interventional
Secondary study design	Randomised cross over trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Effects of ethanol on injury-induced changes in cardiovascular control
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/06/2001
Completion date	30/06/2004

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Male
Target number of participants	Not provided at time of registration
Key inclusion criteria	Healthy male volunteers
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/2001
Date of final enrolment	30/06/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University Hospital of North Durham

Durham
DH1 5TW
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

County Durham and Darlington Acute Hospitals NHS Trust (North) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

25/03/2020: No publications found, all search options exhausted, study status unverified.