Condition category
Circulatory System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
28/11/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D Thomas

ORCID ID

Contact details

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

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

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

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

Publication citations

Additional files

Editorial Notes