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

Peripheral Arterial Occlusive Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682889
• Other study ID #: MUW_Arginin
• Status: Completed
• Phase: Phase 4
• First received: September 3, 2012
• Last updated: September 6, 2012
• Start date: January 2007
• Est. completion date: January 2012

Study information

• Verified date: September 2012
• Source: Medical Scientific Fund of the Mayor of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• female or male patients receiving peripheral bypass surgery

• age between 55 and 75 years

Exclusion Criteria:

• metabolic acidosis

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Peripheral Arterial Disease
• Peripheral Arterial Occlusive Disease

Intervention

Dietary Supplement:
• Arginine
L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours
• Placebo
NaCl 0.9% intravenously for 24h

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical Scientific Fund of the Mayor of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change from baseline in Laser Doppler blood perfusion imaging at 1h	Perfusion values are expressed as arbitrary perfusion units.	baseline & 1h post-surgery	No
Secondary	Change from baseline in Laser Doppler blood perfusion imaging at 2h	Perfusion values are expressed as arbitrary perfusion units.	baseline & 2h post-surgery	No
Secondary	Change from baseline in Laser Doppler blood perfusion imaging at 3h	Perfusion values are expressed as arbitrary perfusion units.	baseline & 3h post-surgery	No
Secondary	Change from baseline in Laser Doppler blood perfusion imaging at 24h	Perfusion values are expressed as arbitrary perfusion units.	baseline & 24h post-surgery	No
Secondary	Change from baseline in Laser Doppler blood perfusion imaging at 48h	Perfusion values are expressed as arbitrary perfusion units.	baseline & 48h post-surgery	No
Secondary	Change from baseline in asymmetric dimethylarginine (ADMA) at 3h	Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.	baseline & 3h post-surgery	No
Secondary	Change from baseline in asymmetric dimethylarginine (ADMA) at 24h	Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.	baseline & 24h post-surgery	No
Secondary	Change from baseline in asymmetric dimethylarginine (ADMA) at 48h	Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.	baseline & 48h post-surgery	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No