The Effect of High Dose Arginine Infusion on Hemodynamic and Peripheral Microcirculation
6. september 2012 oppdatert av: Ass.-Prof. DI Dr. Barbara Wessner, Medical Scientific Fund of the Mayor of Vienna
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).
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Vienna, Østerrike, 1090
- Medical University of Vienna
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
55 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- female or male patients receiving peripheral bypass surgery
- age between 55 and 75 years
Exclusion Criteria:
- metabolic acidosis
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
NaCl 0.9% intravenously for 24 hours after induction of anaesthesia
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NaCl 0.9% intravenously for 24h
|
|
Aktiv komparator: Arginine
L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours after induction of anaesthesia
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L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in temperature gradient at 3h post-surgery
Tidsramme: 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.
|
baseline and 3h post-surgery
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Laser Doppler blood perfusion imaging at 1h
Tidsramme: baseline & 1h post-surgery
|
Perfusion values are expressed as arbitrary perfusion units.
|
baseline & 1h post-surgery
|
|
Change from baseline in Laser Doppler blood perfusion imaging at 2h
Tidsramme: baseline & 2h post-surgery
|
Perfusion values are expressed as arbitrary perfusion units.
|
baseline & 2h post-surgery
|
|
Change from baseline in Laser Doppler blood perfusion imaging at 3h
Tidsramme: baseline & 3h post-surgery
|
Perfusion values are expressed as arbitrary perfusion units.
|
baseline & 3h post-surgery
|
|
Change from baseline in Laser Doppler blood perfusion imaging at 24h
Tidsramme: baseline & 24h post-surgery
|
Perfusion values are expressed as arbitrary perfusion units.
|
baseline & 24h post-surgery
|
|
Change from baseline in Laser Doppler blood perfusion imaging at 48h
Tidsramme: baseline & 48h post-surgery
|
Perfusion values are expressed as arbitrary perfusion units.
|
baseline & 48h post-surgery
|
|
Change from baseline in asymmetric dimethylarginine (ADMA) at 3h
Tidsramme: baseline & 3h post-surgery
|
Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
|
baseline & 3h post-surgery
|
|
Change from baseline in asymmetric dimethylarginine (ADMA) at 24h
Tidsramme: baseline & 24h post-surgery
|
Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
|
baseline & 24h post-surgery
|
|
Change from baseline in asymmetric dimethylarginine (ADMA) at 48h
Tidsramme: baseline & 48h post-surgery
|
Asymmetric dimethylarginine is measured by ELISA and expressed in µmol/l.
|
baseline & 48h post-surgery
|
|
Change from baseline in plasma arginine concentration at 3h
Tidsramme: baseline & 3h post-surgery
|
L-arginine concentration is measured by HPLC and expressed in µmol/l.
|
baseline & 3h post-surgery
|
|
Change from baseline in plasma arginine concentration at 24h
Tidsramme: baseline & 24h post-surgery
|
L-arginine concentration is measured by HPLC and expressed in µmol/l.
|
baseline & 24h post-surgery
|
|
Change from baseline in plasma arginine concentration at 48h
Tidsramme: baseline & 48h post-surgery
|
L-arginine concentration is measured by HPLC and expressed in µmol/l.
|
baseline & 48h post-surgery
|
|
Change from baseline in temperature gradient at 1h
Tidsramme: 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.
|
baseline & 1h post-surgery
|
|
Change from baseline in temperature gradient at 2h
Tidsramme: 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.
|
baseline & 2h post-surgery
|
|
Change from baseline in temperature gradient at 24h
Tidsramme: 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.
|
baseline & 24h post-surgery
|
|
Change from baseline in temperature gradient at 48h
Tidsramme: 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.
|
baseline & 48h post-surgery
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Jörg Michael Hiesmayr, Prof. Dr., Medical University of Vienna
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2007
Primær fullføring (Faktiske)
1. desember 2008
Studiet fullført (Faktiske)
1. januar 2012
Datoer for studieregistrering
Først innsendt
3. september 2012
Først innsendt som oppfylte QC-kriteriene
6. september 2012
Først lagt ut (Anslag)
11. september 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
11. september 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. september 2012
Sist bekreftet
1. september 2012
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MUW_Arginin
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