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

Primary Purpose

Peripheral Arterial Occlusive Disease

Status
Completed
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
Arginine
Placebo
Sponsored by
Medical Scientific Fund of the Mayor of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Peripheral Arterial Occlusive Disease

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • metabolic acidosis

Sites / Locations

  • Medical University of Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Arginine

Arm Description

NaCl 0.9% intravenously for 24 hours after induction of anaesthesia

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2012
Last Updated
September 6, 2012
Sponsor
Medical Scientific Fund of the Mayor of Vienna
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1. Study Identification

Unique Protocol Identification Number
NCT01682889
Brief Title
The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical Scientific Fund of the Mayor of Vienna

4. Oversight

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Occlusive Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
NaCl 0.9% intravenously for 24 hours after induction of anaesthesia
Arm Title
Arginine
Arm Type
Active Comparator
Arm Description
L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours after induction of anaesthesia
Intervention Type
Dietary Supplement
Intervention Name(s)
Arginine
Intervention Description
L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
NaCl 0.9% intravenously for 24h
Primary Outcome Measure Information:
Title
Change from baseline in temperature gradient at 3h post-surgery
Description
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.
Time Frame
baseline and 3h post-surgery
Secondary Outcome Measure Information:
Title
Change from baseline in Laser Doppler blood perfusion imaging at 1h
Description
Perfusion values are expressed as arbitrary perfusion units.
Time Frame
baseline & 1h post-surgery
Title
Change from baseline in Laser Doppler blood perfusion imaging at 2h
Description
Perfusion values are expressed as arbitrary perfusion units.
Time Frame
baseline & 2h post-surgery
Title
Change from baseline in Laser Doppler blood perfusion imaging at 3h
Description
Perfusion values are expressed as arbitrary perfusion units.
Time Frame
baseline & 3h post-surgery
Title
Change from baseline in Laser Doppler blood perfusion imaging at 24h
Description
Perfusion values are expressed as arbitrary perfusion units.
Time Frame
baseline & 24h post-surgery
Title
Change from baseline in Laser Doppler blood perfusion imaging at 48h
Description
Perfusion values are expressed as arbitrary perfusion units.
Time Frame
baseline & 48h post-surgery
Title
Change from baseline in asymmetric dimethylarginine (ADMA) at 3h
Description
Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
Time Frame
baseline & 3h post-surgery
Title
Change from baseline in asymmetric dimethylarginine (ADMA) at 24h
Description
Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
Time Frame
baseline & 24h post-surgery
Title
Change from baseline in asymmetric dimethylarginine (ADMA) at 48h
Description
Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
Time Frame
baseline & 48h post-surgery
Title
Change from baseline in plasma arginine concentration at 3h
Description
L-arginine concentration is measured by HPLC and expressed in µmol/l.
Time Frame
baseline & 3h post-surgery
Title
Change from baseline in plasma arginine concentration at 24h
Description
L-arginine concentration is measured by HPLC and expressed in µmol/l.
Time Frame
baseline & 24h post-surgery
Title
Change from baseline in plasma arginine concentration at 48h
Description
L-arginine concentration is measured by HPLC and expressed in µmol/l.
Time Frame
baseline & 48h post-surgery
Title
Change from baseline in temperature gradient at 1h
Description
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.
Time Frame
baseline & 1h post-surgery
Title
Change from baseline in temperature gradient at 2h
Description
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.
Time Frame
baseline & 2h post-surgery
Title
Change from baseline in temperature gradient at 24h
Description
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.
Time Frame
baseline & 24h post-surgery
Title
Change from baseline in temperature gradient at 48h
Description
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.
Time Frame
baseline & 48h post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: female or male patients receiving peripheral bypass surgery age between 55 and 75 years Exclusion Criteria: metabolic acidosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jörg Michael Hiesmayr, Prof. Dr.
Organizational Affiliation
Medical University of Vienna
Official's Role
Study Director
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria

12. IPD Sharing Statement

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

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