- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01518569
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 4
Kontakter og plasseringer
Studiesteder
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Seoul, Korea, Republikken, 143-729
- Konkuk University Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Trippel
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: placebo
normal saline, same amount, iv
|
placebo (the same amount of normal saline) iv before the initiation of CPB
Andre navn:
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Aktiv komparator: ulinastatin
5000 unit/kg iv
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ulinastatin 5000 unit/kg iv before the initiation of CPB
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
bactericidal permeability increasing protein
Tidsramme: 5-30 min before the end of anesthesia
|
5-30 min before the end of anesthesia
|
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interleukin-6
Tidsramme: 5-30 min before the end of anesthesia
|
5-30 min before the end of anesthesia
|
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tumor necrosis factorTNF-α
Tidsramme: 5-30 min before the end of anesthesia
|
5-30 min before the end of anesthesia
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Creatine kinase-MB
Tidsramme: 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
Tidsramme: 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
Tidsramme: before anesthesia, 24 hour after the end of anesthesia
|
before anesthesia, 24 hour after the end of anesthesia
|
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serum creatinine
Tidsramme: before anesthesia, 24 hour after the end of anesthesia
|
before anesthesia, 24 hour after the end of anesthesia
|
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PaO2/FiO2 ratio
Tidsramme: before anesthesia, 24 hour after the end of anesthesia
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before anesthesia, 24 hour after the end of anesthesia
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
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
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- KUH1160040
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