Peripheral Arterial Occlusive Disease
Conditions
Brief summary
The aim of this study was to investigate the effect of a 24- hrs L-arginine infusion on hemodynamic and on parameters of microcirculation in patients with peripheral arterial occlusive disease (PAOD).
Interventions
DIETARY_SUPPLEMENTArginine
L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours
DIETARY_SUPPLEMENTPlacebo
NaCl 0.9% intravenously for 24h
Sponsors
Medical Scientific Fund of the Mayor of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* female or male patients receiving peripheral bypass surgery * age between 55 and 75 years
Exclusion criteria
* metabolic acidosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in temperature gradient at 3h post-surgery | baseline and 3h post-surgery | One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Laser Doppler blood perfusion imaging at 2h | baseline & 2h post-surgery | Perfusion values are expressed as arbitrary perfusion units. |
| Change from baseline in Laser Doppler blood perfusion imaging at 3h | baseline & 3h post-surgery | Perfusion values are expressed as arbitrary perfusion units. |
| Change from baseline in Laser Doppler blood perfusion imaging at 24h | baseline & 24h post-surgery | Perfusion values are expressed as arbitrary perfusion units. |
| Change from baseline in Laser Doppler blood perfusion imaging at 48h | baseline & 48h post-surgery | Perfusion values are expressed as arbitrary perfusion units. |
| Change from baseline in asymmetric dimethylarginine (ADMA) at 3h | baseline & 3h post-surgery | Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l. |
| Change from baseline in asymmetric dimethylarginine (ADMA) at 24h | baseline & 24h post-surgery | Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l. |
| Change from baseline in asymmetric dimethylarginine (ADMA) at 48h | baseline & 48h post-surgery | Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l. |
| Change from baseline in Laser Doppler blood perfusion imaging at 1h | baseline & 1h post-surgery | Perfusion values are expressed as arbitrary perfusion units. |
| Change from baseline in plasma arginine concentration at 24h | baseline & 24h post-surgery | L-arginine concentration is measured by HPLC and expressed in µmol/l. |
| Change from baseline in plasma arginine concentration at 48h | baseline & 48h post-surgery | L-arginine concentration is measured by HPLC and expressed in µmol/l. |
| Change from baseline in temperature gradient at 1h | baseline & 1h post-surgery | One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C. |
| Change from baseline in temperature gradient at 2h | baseline & 2h post-surgery | One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C. |
| Change from baseline in temperature gradient at 24h | baseline & 24h post-surgery | One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C. |
| Change from baseline in temperature gradient at 48h | baseline & 48h post-surgery | One temperature probe is attached to the index finger of the lying patients, a second probe at the radial side of the forearm, midway between elbow and the wrist. Temperature gradient is calculated by subtracting the value obtained at the fingertip from the forearm value and expressed in °C. |
| Change from baseline in plasma arginine concentration at 3h | baseline & 3h post-surgery | L-arginine concentration is measured by HPLC and expressed in µmol/l. |
Countries
Austria
Outcome results
None listed