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

NCT01682889 | Completed Phase 4

• 1 other identifier: MUW_Arginin
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Arterial Occlusive Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Change from baseline in Laser Doppler blood perfusion imaging at 1h

  baseline & 1h post-surgery

• Change from baseline in Laser Doppler blood perfusion imaging at 2h

  baseline & 2h post-surgery

• Change from baseline in Laser Doppler blood perfusion imaging at 3h

  baseline & 3h post-surgery

• Change from baseline in Laser Doppler blood perfusion imaging at 24h

  baseline & 24h post-surgery

• Change from baseline in Laser Doppler blood perfusion imaging at 48h

  baseline & 48h post-surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

NaCl 0.9% intravenously for 24 hours after induction of anaesthesia

Dietary Supplement: Placebo

Arginine

ACTIVE COMPARATOR

L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours after induction of anaesthesia

Dietary Supplement: Arginine

Interventions

Arginine DIETARY_SUPPLEMENT

L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours

Arginine

Placebo DIETARY_SUPPLEMENT

NaCl 0.9% intravenously for 24h

Placebo

Eligibility Criteria

• Age: 55 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• metabolic acidosis

Sponsors & Collaborators

• Medical Scientific Fund of the Mayor of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Peripheral Arterial Occlusive Disease 1

Interventions

Arginine

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Jörg Michael Hiesmayr, Prof. Dr.

  Medical University of Vienna

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.-Prof. DI Dr.

Study Record Dates

• First Submitted: September 3, 2012
• First Posted: September 11, 2012
• Study Start: January 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2012
• Last Updated: September 11, 2012

Record last verified: 2012-09

Locations

AU (1)