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Completed

NCT Number: NCT01682889

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

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).

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Key information

Conditions

Peripheral Arterial Occlusive Disease Peripheral Arterial Occlusive Disease 1

Age range

55 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Medical University of Vienna

Vienna, State of Vienna, 1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • metabolic acidosis

Treatment and study plan

Arginine

Dietary Supplement

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

Placebo

Dietary Supplement

NaCl 0.9% intravenously for 24h

Primary outcomes

  1. Change from baseline in temperature gradient at 3h post-surgery

    Time frame: baseline and 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 outcomes

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

    Time frame: baseline & 1h post-surgery

    Perfusion values are expressed as arbitrary perfusion units.

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

    Time frame: baseline & 2h post-surgery

    Perfusion values are expressed as arbitrary perfusion units.

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

    Time frame: baseline & 3h post-surgery

    Perfusion values are expressed as arbitrary perfusion units.

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

    Time frame: baseline & 24h post-surgery

    Perfusion values are expressed as arbitrary perfusion units.

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

    Time frame: baseline & 48h post-surgery

    Perfusion values are expressed as arbitrary perfusion units.

  6. Change from baseline in asymmetric dimethylarginine (ADMA) at 3h

    Time frame: baseline & 3h post-surgery

    Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.

  7. Change from baseline in asymmetric dimethylarginine (ADMA) at 24h

    Time frame: baseline & 24h post-surgery

    Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.

  8. Change from baseline in asymmetric dimethylarginine (ADMA) at 48h

    Time frame: baseline & 48h post-surgery

    Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.

  9. Change from baseline in plasma arginine concentration at 3h

    Time frame: baseline & 3h post-surgery

    L-arginine concentration is measured by HPLC and expressed in µmol/l.

  10. Change from baseline in plasma arginine concentration at 24h

    Time frame: baseline & 24h post-surgery

    L-arginine concentration is measured by HPLC and expressed in µmol/l.

  11. Change from baseline in plasma arginine concentration at 48h

    Time frame: baseline & 48h post-surgery

    L-arginine concentration is measured by HPLC and expressed in µmol/l.

  12. Change from baseline in temperature gradient at 1h

    Time frame: baseline & 1h 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.

  13. Change from baseline in temperature gradient at 2h

    Time frame: baseline & 2h 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.

  14. Change from baseline in temperature gradient at 24h

    Time frame: baseline & 24h 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.

  15. Change from baseline in temperature gradient at 48h

    Time frame: baseline & 48h 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.

Sponsors and collaborators

Lead sponsor

Medical Scientific Fund of the Mayor of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2012
First posted
Sep 11, 2012
Registry last updated
Sep 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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