- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02144298
The Sublingual Microcirculatory Alterations in Patients Undergoing Extracorporeal Flow Conditions
The Perioperative Course of Sublingual Microcirculatory Alterations in Patients Undergoing Extracorporeal Flow Conditions: Cold Blood Compared With Cristalloid Cardioplegia
Studieoversikt
Status
Forhold
Detaljert beskrivelse
The microcirculatory measurements were obtained in both groups in the sublingual mucosa using Cytocam imaging. The probe was handheld. Different precautions were taken and steps followed to obtain images of adequate quality and to ensure good reproducibility.
Images were made after induction of anesthesia (t0), before CBP 5 minutes after heparine (t1), 5 minutes after CBP beginning (t2), during CBP 10 minutes after crossclamp beginning (t3), after crossclamp ending when heart begins to beat (t4), after CBP 10 minutes after protamine (t5).
Additional images were made before (tc0) and after (tc1) vasoactive medication; before (tv0) and after (tv1) volume administration; before (tb0) and after (tb1) blood administration, (FFP, PLT).
At each timepoint adequate focus depth and contrast were noticed. Three steady images of 6 seconds were acquired and recorded on a device controller based on a powerful medical grade computer which is used for image storage and analysis.
Additionally macrocirculatory measurements were obtained at the same timepoints. Hemodynamic variables, temperature, blood gas, INVOS, StO2, laboratory findings and standart therapy were recorded. Additionally intubation time, ICU stay, hospital stay, ICU readmission, morbidity and mortality were studied.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Istanbul, Tyrkia
- Acıbadem University Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- patients undergoing coronary artery bypass grafting (CABG)
Exclusion Criteria:
- previous heart and oral surgery
- age below 18 years,
- emergency surgery
- pregnancy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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cold blood cardioplegia
observe the perioperative course of sublingual microcirculatory alterations in patients undergoing coronary artery bypass grafting (CABG) using cold blood cardioplegia.
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cristalloid cardioplegia
observe the perioperative course of sublingual microcirculatory alterations in patients undergoing coronary artery bypass grafting (CABG) using cristalloid cardioplegia.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
functional capillary density
Tidsramme: moment of measurement
|
functional capillary density is expected to be lower in the cryaloide group
|
moment of measurement
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
percentage perfused density
Tidsramme: time of measurement
|
a higher percentage of perfused vessel density is expected in the blood group
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time of measurement
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Can Ince, Prof, Medical Centre Amsterdam
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- ATADEK 2013-540
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