The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation

Phase 4

Completed

• Conditions: Peripheral Arterial Occlusive Disease
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: Arginine

• Registration Number: NCT01682889
• Lead Sponsor: Medical Scientific Fund of the Mayor of Vienna

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Primary Completion: 2008-12
• Study Completion: 2012-01
• Status Verified: 2012-09
• Study First Submitted: 2012-09-03
• Study First Submitted QC: 2012-09-06
• Last Update Submitted: 2012-09-06
• Study First Posted: 2012-09-11
• Last Update Posted: 2012-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• female or male patients receiving peripheral bypass surgery
• age between 55 and 75 years

Exclusion Criteria

• metabolic acidosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	NaCl 0.9% intravenously for 24 hours after induction of anaesthesia
Arginine	Arginine	L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours after induction of anaesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 plasma arginine concentration at 3h	baseline & 3h post-surgery	L-arginine concentration is measured by HPLC and expressed in µmol/l.
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.

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria