Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery (ulistin)
Effect of Ulinastatin on Postoperative Systemic Inflammatory Response in Cardiac Surgery
The purpose of the present study is to determine whether ulinastatin, urinary anti-trypsin inhibitor, attenuates cardiopulmonary bypass (CPB)-activated systemic inflammatory response in cardiac surgery with CPB.
Serial measurements and analysis of several inflammatory cytokines (bactericidal permeability increasing protein, interleukin-6, tumor necrosis factor-α)as well as markers of cardiac injury, renal impairment and oxygenation profile will be performed to determine ulinastatin's efficacy.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Applying aortic cross-clamp (ACC) and cardiopulmonary bypass (CPB) for cardiac surgery produces variable systemic inflammatory reactions. As a common complication of those reactions, pulmonary dysfunction, which usually indicated by postoperative hypoxemia, is frequently associated with cardiac surgery employing CPB and has been used as a major predictor of morbidity and mortality.
Circulating humoral and cellular factors are involved in the development of the systemic inflammatory reactions including organ dysfunction. So far, many studies analyzed the concentration of inflammatory marker (cytokine) to determine the degree of systemic inflammatory responses in various conditions.
Ulinastatin has anti-inflammatory activity and suppresses the infiltration of neutrophils. Previous studies suggested ulinastatin's cytoprotective effect against ischemia-reperfusion injury in major organs and its inhibition of inflammatory marker production.
The purpose of the present study is to determine ulinastatin's possible protective efficacy of in attenuating CPB-activated systemic inflammatory response regarding postoperative cardiac, renal and pulmonary dysfunction in cardiac surgery with CPB. Serial measurements and analysis of several inflammatory cytokines, such as bactericidal permeability increasing protein (BPI), interleukin (IL)-6, tumor necrosis factor (TNF)-α, as well as markers of cardiac injury, renal impairment and oxygenation profile, such as creatine kinase-MB (CK-MB), troponin I (TnI), C-reactive protein (CRP), arterial O2 tension /inspired O2 fraction (PaO2/FiO2 ratio), will be performed to this purpose.
Type d'étude
Inscription (Réel)
Phase
- Phase 4
Contacts et emplacements
Lieux d'étude
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-
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Seoul, Corée, République de, 143-729
- Konkuk University Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- elective cardiac surgery employing CPB
Exclusion Criteria:
- urgent/emergency surgery,
- previous heart surgery,
- combined CABG and valve surgery,
- age > 75 yrs,
- left ventricular ejection fraction < 0.45,
- diabetes treated with insulin,
- active gastropathic disorder,
- treatment for chronic obstructive pulmonary disease,
- preoperative use of steroids
- postoperative re-operation due to bleeding control
- pre and postoperative renal replacement therapy
- left ventricular assist device implantation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: placebo
normal saline, same amount, iv
|
placebo (the same amount of normal saline) iv before the initiation of CPB
Autres noms:
|
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Comparateur actif: ulinastatin
5000 unit/kg iv
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ulinastatin 5000 unit/kg iv before the initiation of CPB
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
bactericidal permeability increasing protein
Délai: 5-30 min before the end of anesthesia
|
5-30 min before the end of anesthesia
|
|
interleukin-6
Délai: 5-30 min before the end of anesthesia
|
5-30 min before the end of anesthesia
|
|
tumor necrosis factorTNF-α
Délai: 5-30 min before the end of anesthesia
|
5-30 min before the end of anesthesia
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Creatine kinase-MB
Délai: before anesthesia, 24 hour after the end of anesthesia
|
before anesthesia, 24 hour after the end of anesthesia
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troponin I
Délai: before anesthesia, 24 hour after the end of anesthesia
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before anesthesia, 24 hour after the end of anesthesia
|
|
C-reactive protein
Délai: before anesthesia, 24 hour after the end of anesthesia
|
before anesthesia, 24 hour after the end of anesthesia
|
|
serum creatinine
Délai: before anesthesia, 24 hour after the end of anesthesia
|
before anesthesia, 24 hour after the end of anesthesia
|
|
PaO2/FiO2 ratio
Délai: before anesthesia, 24 hour after the end of anesthesia
|
before anesthesia, 24 hour after the end of anesthesia
|
Collaborateurs et enquêteurs
Parrainer
Publications et liens utiles
Publications générales
- Nakanishi K, Takeda S, Sakamoto A, Kitamura A. Effects of ulinastatin treatment on the cardiopulmonary bypass-induced hemodynamic instability and pulmonary dysfunction. Crit Care Med. 2006 May;34(5):1351-7. doi: 10.1097/01.CCM.0000215110.55899.AE.
- Hill GE. Cardiopulmonary bypass-induced inflammation: is it important? J Cardiothorac Vasc Anesth. 1998 Apr;12(2 Suppl 1):21-5.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
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 (Estimation)
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
Autres numéros d'identification d'étude
- KUH1160040
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