Peripheral Arterial Occlusive DiseasePhase 4NCT01682889
The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation
A Phase 4 study testing Arginine in people with Peripheral Arterial Occlusive Disease, run by Medical Scientific Fund of the Mayor of Vienna at 1 site in Austria.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Peripheral Arterial Occlusive Disease
- What is being tested?
- Arginine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2007to Jan 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female or male patients receiving peripheral bypass surgery
- age between 55 and 75 years
Who cannot join
- metabolic acidosis
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Arginine, Placebo
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArginineDietary supplement
L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours
PlaceboDietary supplement
NaCl 0.9% intravenously for 24h
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | NaCl 0.9% intravenously for 24 hours after induction of anaesthesia Receives: Dietary Supplement: Placebo |
| Arginine | Active comparator | L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours after induction of anaesthesia Receives: Dietary Supplement: Arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3h post-surgery
Secondary outcomes (15)
Change from baseline in Laser Doppler blood perfusion imaging at 1h
Perfusion values are expressed as arbitrary perfusion units.
Measured: baseline & 1h post-surgery
Change from baseline in Laser Doppler blood perfusion imaging at 2h
Perfusion values are expressed as arbitrary perfusion units.
Measured: baseline & 2h post-surgery
Change from baseline in Laser Doppler blood perfusion imaging at 3h
Perfusion values are expressed as arbitrary perfusion units.
Measured: baseline & 3h post-surgery
Change from baseline in Laser Doppler blood perfusion imaging at 24h
Perfusion values are expressed as arbitrary perfusion units.
Measured: baseline & 24h post-surgery
Change from baseline in Laser Doppler blood perfusion imaging at 48h
Perfusion values are expressed as arbitrary perfusion units.
Measured: baseline & 48h post-surgery
Change from baseline in asymmetric dimethylarginine (ADMA) at 3h
Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
Measured: baseline & 3h post-surgery
Change from baseline in asymmetric dimethylarginine (ADMA) at 24h
Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
Measured: baseline & 24h post-surgery
Change from baseline in asymmetric dimethylarginine (ADMA) at 48h
Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
Measured: baseline & 48h post-surgery
Change from baseline in plasma arginine concentration at 3h
L-arginine concentration is measured by HPLC and expressed in µmol/l.
Measured: baseline & 3h post-surgery
Change from baseline in plasma arginine concentration at 24h
L-arginine concentration is measured by HPLC and expressed in µmol/l.
Measured: baseline & 24h post-surgery
Change from baseline in plasma arginine concentration at 48h
L-arginine concentration is measured by HPLC and expressed in µmol/l.
Measured: baseline & 48h post-surgery
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.
Measured: baseline & 1h post-surgery
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.
Measured: baseline & 2h post-surgery
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.
Measured: baseline & 24h post-surgery
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.
Measured: baseline & 48h post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startJan 2007
- Primary completionDec 2008
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial Occlusive DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Scientific Fund of the Mayor of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ass.-Prof. DI Dr. Barbara Wessner, Medical University of Vienna
- Investigators
- Jörg Michael Hiesmayr, Prof. Dr., Study director, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682889
- Sponsor's protocol ID
- MUW_Arginin
- Status last verified
- Sep 2012
- First submitted
- 3 Sep 2012
- Last updated
- 11 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01682889
- Acronym / sponsor ID
- MUW_Arginin
- Conditions
- Peripheral Arterial Occlusive Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical Scientific Fund of the Mayor of ViennaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboNaCl 0.9% intravenously for 24 hours after induction of anaesthesia |
| Arginine | Active comparator | Dietary Supplement: ArginineL-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours after induction of anaesthesia |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- female or male patients receiving peripheral bypass surgery
- age between 55 and 75 years
Key exclusion criteria (1 listed)
- metabolic acidosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArginineL-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours | Dietary supplement | Arginine |
| PlaceboNaCl 0.9% intravenously for 24h | Dietary supplement | Placebo |
Primary outcome
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.
15 secondary outcomes
Change from baseline in Laser Doppler blood perfusion imaging at 1h
Time frame: baseline & 1h post-surgery
Change from baseline in Laser Doppler blood perfusion imaging at 2h
Time frame: baseline & 2h post-surgery
Change from baseline in Laser Doppler blood perfusion imaging at 3h
Time frame: baseline & 3h post-surgery
Change from baseline in Laser Doppler blood perfusion imaging at 24h
Time frame: baseline & 24h post-surgery
Change from baseline in Laser Doppler blood perfusion imaging at 48h
Time frame: baseline & 48h post-surgery
Change from baseline in asymmetric dimethylarginine (ADMA) at 3h
Time frame: baseline & 3h post-surgery
Change from baseline in asymmetric dimethylarginine (ADMA) at 24h
Time frame: baseline & 24h post-surgery
Change from baseline in asymmetric dimethylarginine (ADMA) at 48h
Time frame: baseline & 48h post-surgery
Change from baseline in plasma arginine concentration at 3h
Time frame: baseline & 3h post-surgery
Change from baseline in plasma arginine concentration at 24h
Time frame: baseline & 24h post-surgery
Change from baseline in plasma arginine concentration at 48h
Time frame: baseline & 48h post-surgery
Change from baseline in temperature gradient at 1h
Time frame: baseline & 1h post-surgery
Change from baseline in temperature gradient at 2h
Time frame: baseline & 2h post-surgery
Change from baseline in temperature gradient at 24h
Time frame: baseline & 24h post-surgery
Change from baseline in temperature gradient at 48h
Time frame: baseline & 48h post-surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jörg Michael Hiesmayr, Prof. Dr. study director
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arginine in people with Peripheral Arterial Occlusive Disease, run by Medical Scientific Fund of the Mayor of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in temperature gradient at 3h post-surgery (time frame: baseline and 3h post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2012.