Effects of ethanol on injury-induced changes in cardiovascular control
| ISRCTN | ISRCTN65746454 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65746454 |
| Protocol serial number | N0521099246 |
| Sponsor | Department of Health |
| Funder | County Durham and Darlington Acute Hospitals NHS Trust (North) (UK) |
- 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
Scientific
University Hospital of North Durham
North Road
Durham
DH1 5TW
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised crossover trial |
| Secondary study design | Randomised cross over trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Male |
| 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
- United Kingdom
- England
Study participating centre
University Hospital of North Durham
Durham
DH1 5TW
United Kingdom
DH1 5TW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
25/03/2020: No publications found, all search options exhausted, study status unverified.
