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

NCT ID: NCT01682889

Last Updated: 2012-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-01-31

Brief Summary

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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).

Detailed Description

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Conditions

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Peripheral Arterial Occlusive Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

NaCl 0.9% intravenously for 24 hours after induction of anaesthesia

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

NaCl 0.9% intravenously for 24h

Arginine

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

Group Type ACTIVE_COMPARATOR

Arginine

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Arginine

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

NaCl 0.9% intravenously for 24h

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* metabolic acidosis
Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Scientific Fund of the Mayor of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Ass.-Prof. DI Dr. Barbara Wessner

Ass.-Prof. DI Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jörg Michael Hiesmayr, Prof. Dr.

Role: STUDY_DIRECTOR

Medical University of Vienna

Locations

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Medical University of Vienna

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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MUW_Arginin

Identifier Type: -

Identifier Source: org_study_id