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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ass.-Prof. DI Dr. Barbara Wessner, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01682889
First received: September 3, 2012
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

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).


Condition Intervention Phase
Peripheral Arterial Occlusive Disease
Dietary Supplement: Arginine
Dietary Supplement: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Medical Scientific Fund of the Mayor of Vienna:

Primary Outcome Measures:
  • Change from baseline in temperature gradient at 3h post-surgery [ Time Frame: baseline and 3h post-surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline & 1h post-surgery ] [ Designated as safety issue: No ]
    Perfusion values are expressed as arbitrary perfusion units.

  • Change from baseline in Laser Doppler blood perfusion imaging at 2h [ Time Frame: baseline & 2h post-surgery ] [ Designated as safety issue: No ]
    Perfusion values are expressed as arbitrary perfusion units.

  • Change from baseline in Laser Doppler blood perfusion imaging at 3h [ Time Frame: baseline & 3h post-surgery ] [ Designated as safety issue: No ]
    Perfusion values are expressed as arbitrary perfusion units.

  • Change from baseline in Laser Doppler blood perfusion imaging at 24h [ Time Frame: baseline & 24h post-surgery ] [ Designated as safety issue: No ]
    Perfusion values are expressed as arbitrary perfusion units.

  • Change from baseline in Laser Doppler blood perfusion imaging at 48h [ Time Frame: baseline & 48h post-surgery ] [ Designated as safety issue: No ]
    Perfusion values are expressed as arbitrary perfusion units.

  • Change from baseline in asymmetric dimethylarginine (ADMA) at 3h [ Time Frame: baseline & 3h post-surgery ] [ Designated as safety issue: No ]
    Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.

  • Change from baseline in asymmetric dimethylarginine (ADMA) at 24h [ Time Frame: baseline & 24h post-surgery ] [ Designated as safety issue: No ]
    Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.

  • Change from baseline in asymmetric dimethylarginine (ADMA) at 48h [ Time Frame: baseline & 48h post-surgery ] [ Designated as safety issue: No ]
    Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.

  • Change from baseline in plasma arginine concentration at 3h [ Time Frame: baseline & 3h post-surgery ] [ Designated as safety issue: No ]
    L-arginine concentration is measured by HPLC and expressed in µmol/l.

  • Change from baseline in plasma arginine concentration at 24h [ Time Frame: baseline & 24h post-surgery ] [ Designated as safety issue: No ]
    L-arginine concentration is measured by HPLC and expressed in µmol/l.

  • Change from baseline in plasma arginine concentration at 48h [ Time Frame: baseline & 48h post-surgery ] [ Designated as safety issue: No ]
    L-arginine concentration is measured by HPLC and expressed in µmol/l.

  • Change from baseline in temperature gradient at 1h [ Time Frame: baseline & 1h post-surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline & 2h post-surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline & 24h post-surgery ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline & 48h post-surgery ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: January 2007
Study Completion Date: January 2012
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • metabolic acidosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01682889

Locations
Austria
Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Medical Scientific Fund of the Mayor of Vienna
Investigators
Study Director: Jörg Michael Hiesmayr, Prof. Dr. Medical University of Vienna
  More Information

No publications provided

Responsible Party: Ass.-Prof. DI Dr. Barbara Wessner, Ass.-Prof. DI Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01682889     History of Changes
Other Study ID Numbers: MUW_Arginin
Study First Received: September 3, 2012
Last Updated: September 6, 2012
Health Authority: Austria: Ethikkommission

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Peripheral Arterial Disease
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014