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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 4
Contatti e Sedi
Luoghi di studio
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Seoul, Corea, Repubblica di, 143-729
- Konkuk University Medical Center
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore placebo: placebo
normal saline, same amount, iv
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placebo (the same amount of normal saline) iv before the initiation of CPB
Altri nomi:
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Comparatore attivo: ulinastatin
5000 unit/kg iv
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ulinastatin 5000 unit/kg iv before the initiation of CPB
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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bactericidal permeability increasing protein
Lasso di tempo: 5-30 min before the end of anesthesia
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5-30 min before the end of anesthesia
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interleukin-6
Lasso di tempo: 5-30 min before the end of anesthesia
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5-30 min before the end of anesthesia
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tumor necrosis factorTNF-α
Lasso di tempo: 5-30 min before the end of anesthesia
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5-30 min before the end of anesthesia
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Creatine kinase-MB
Lasso di tempo: before anesthesia, 24 hour after the end of anesthesia
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before anesthesia, 24 hour after the end of anesthesia
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troponin I
Lasso di tempo: before anesthesia, 24 hour after the end of anesthesia
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before anesthesia, 24 hour after the end of anesthesia
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C-reactive protein
Lasso di tempo: before anesthesia, 24 hour after the end of anesthesia
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before anesthesia, 24 hour after the end of anesthesia
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serum creatinine
Lasso di tempo: before anesthesia, 24 hour after the end of anesthesia
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before anesthesia, 24 hour after the end of anesthesia
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PaO2/FiO2 ratio
Lasso di tempo: before anesthesia, 24 hour after the end of anesthesia
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before anesthesia, 24 hour after the end of anesthesia
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- KUH1160040
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