- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02136979
Effect of Anesthetics on CD39 and CD73 After Open-heart Surgery
Effect of Propofol and Sevoflurane on Serum CD39 and CD73 Level After Open Heart Surgery With Cardiopulmonary Bypass
CD39 and CD73 was known protein expressed on surface of Th1 and Th17 cell and modulate immune related reaction. Cardiopulmonary bypass (CPB) can induce inflammatory reaction during cardiac surgery, and induce immunosuppression. Propofol and volatile anesthetics were related to immune reaction. However, the effect of propofol and sevoflurane on the change of CD39 and CD73 after CPB was not evaluated in previous studies.
The authors hypothesized that the expression of CD39 and CD73 would differ between propofol- and volatile anaesthetic-based anaesthesia in patients undergoing CPB. Therefore, the present study determined the effect of propofol and sevoflurane on CD39 and CD73 during and after CPB.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
After obtaining permission of the Institutional Review Board of Konkuk University Medical Center, Seoul, South Korea , patients scheduled to undergo elective cardiac surgery under cardiopulmonary bypass (CPB) after signed written informed consent agreements and prospectively participate in the present study.
All patients got a cardiac surgery under moderate hypothermic cardiopulmonary bypass (CPB) by one cardiac surgeon. Also, 6ml of blood and sample was obtained for total 5 times in consecutive order.
- Before operation (pre-CPB1)
- 15 minute after successful CPB weaning (post-CPB1)
- 3 hrs after CPB weaning (post-CPB2)
- 24 hrs after CPB weaning (post-CPB3)
- 48 hrs after CPB weaning (post-CPB4)
The following intraoperative exclusion criteria are applied:
- Emergency operation that could not obtain pre-CPB1 sample
- Patients who have infectious factor before operation
- Patients who have immunosuppressive agent for underlying disease before operation
- Patients who have history of cancer previously
- Patients who are younger than 19 years old
Using blood sample, authors examined as follows
- Flow cytometry for Th 17 and Th 1 cell.
- Immunocytochemistry for CD39, CD73.
- Assay for IL 1,6,10,17,IFN-γ, and TNF-α
- patient vital sign during operation
- other laboratory tests
Statistical analyses are conducted using SPSS 20.0 (SPSS Inc., Chicago, IL, USA). CD39 and CD73 are analysed used a Repeated Measures Analysis of Variance and their pairwise multiple comparisons are performed via the tukey method. The comparisons of the other continuous variables are performed by paired t or Wilcoxon Signed Rank tests. Data are expressed as mean ± SD (95% confidence interval. CI) or median (25%-75%), and number of the patients. A p value less than 0.05 is considered statistically significant.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
-
-
-
Seoul, Corée, République de, 143-729
- Konkuk University Medical Center
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- patients scheduled to undergo elective cardiac surgery
- signed written informed consent agreements
Exclusion Criteria:
- Emergency operation that could not obtain pre-CPB1 sample
- Patients who have infectious factor before operation
- Patients who have immunosuppressive agent for underlying disease before operation
- Patients who have history of cancer previously
- Patients who are younger than 19 years old
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation factorielle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Propofol group
patients with propofol-based anesthesia
|
group of patients with propofol-based anesthesia
Autres noms:
|
|
Comparateur actif: Sevoflurane group
patients with sevoflurane-based anesthesia
|
group of patients with sevoflurane-based anesthesia
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The level of CD39 and CD73 between propofol and sevoflurane group after CPB
Délai: from preoperative status up to 48 hrs after CPB weaning status
|
The difference of CD39 and CD73 level between propofol and sevoflurane group
|
from preoperative status up to 48 hrs after CPB weaning status
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Seong-Hyop Kim, M.D, Ph.D, Konkuk University Medical Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies cardiovasculaires
- Maladies vasculaires
- Maladies cardiaques
- Maladies des valves cardiaques
- Maladies aortiques
- Effets physiologiques des médicaments
- Dépresseurs du système nerveux central
- Anesthésiques intraveineux
- Anesthésiques, général
- Anesthésiques
- Inhibiteurs de l'agrégation plaquettaire
- Hypnotiques et sédatifs
- Anesthésiques, Inhalation
- Propofol
- Sévoflurane
Autres numéros d'identification d'étude
- KUH1160064
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .