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

The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation: a Randomized, Controlled Clinical Trial in Patients Receiving Peripheral Vascular Surgery

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).

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Occlusive Disease
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Arginine

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• metabolic acidosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; NaCl 0.9% intravenously for 24 hours after induction of anaesthesia	Dietary supplement: Placebo; NaCl 0.9% intravenously for 24h
Active Comparator: Arginine; L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours after induction of anaesthesia	Dietary supplement: Arginine; L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in temperature gradient at 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.	baseline and 3h post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Laser Doppler blood perfusion imaging at 1h	Perfusion values are expressed as arbitrary perfusion units.	baseline & 1h post-surgery
Change from baseline in Laser Doppler blood perfusion imaging at 2h	Perfusion values are expressed as arbitrary perfusion units.	baseline & 2h post-surgery
Change from baseline in Laser Doppler blood perfusion imaging at 3h	Perfusion values are expressed as arbitrary perfusion units.	baseline & 3h post-surgery
Change from baseline in Laser Doppler blood perfusion imaging at 24h	Perfusion values are expressed as arbitrary perfusion units.	baseline & 24h post-surgery
Change from baseline in Laser Doppler blood perfusion imaging at 48h	Perfusion values are expressed as arbitrary perfusion units.	baseline & 48h post-surgery
Change from baseline in asymmetric dimethylarginine (ADMA) at 3h	Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.	baseline & 3h post-surgery
Change from baseline in asymmetric dimethylarginine (ADMA) at 24h	Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.	baseline & 24h post-surgery
Change from baseline in asymmetric dimethylarginine (ADMA) at 48h	Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.	baseline & 48h post-surgery
Change from baseline in plasma arginine concentration at 3h	L-arginine concentration is measured by HPLC and expressed in µmol/l.	baseline & 3h post-surgery
Change from baseline in plasma arginine concentration at 24h	L-arginine concentration is measured by HPLC and expressed in µmol/l.	baseline & 24h post-surgery
Change from baseline in plasma arginine concentration at 48h	L-arginine concentration is measured by HPLC and expressed in µmol/l.	baseline & 48h post-surgery
Change from baseline in temperature gradient at 1h	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.	baseline & 1h post-surgery
Change from baseline in temperature gradient at 2h	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.	baseline & 2h post-surgery
Change from baseline in temperature gradient at 24h	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.	baseline & 24h post-surgery
Change from baseline in temperature gradient at 48h	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.	baseline & 48h post-surgery

Collaborators and Investigators

• Sponsor: Medical Scientific Fund of the Mayor of Vienna
• Investigators: Study Director: Jörg Michael Hiesmayr, Prof. Dr., Medical University of Vienna

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: September 3, 2012
• First Submitted That Met QC Criteria: September 6, 2012
• First Posted (Estimate): September 11, 2012

Study Record Updates

• Last Update Posted (Estimate): September 11, 2012
• Last Update Submitted That Met QC Criteria: September 6, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arterial Occlusive Diseases
• Other Study ID Numbers: MUW_Arginin