- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
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Seoul, Korea, Republiken av, 143-729
- Konkuk University Medical Center
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: placebo
normal saline, same amount, iv
|
placebo (the same amount of normal saline) iv before the initiation of CPB
Andra namn:
|
|
Aktiv komparator: ulinastatin
5000 unit/kg iv
|
ulinastatin 5000 unit/kg iv before the initiation of CPB
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
bactericidal permeability increasing protein
Tidsram: 5-30 min before the end of anesthesia
|
5-30 min before the end of anesthesia
|
|
interleukin-6
Tidsram: 5-30 min before the end of anesthesia
|
5-30 min before the end of anesthesia
|
|
tumor necrosis factorTNF-α
Tidsram: 5-30 min before the end of anesthesia
|
5-30 min before the end of anesthesia
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Creatine kinase-MB
Tidsram: before anesthesia, 24 hour after the end of anesthesia
|
before anesthesia, 24 hour after the end of anesthesia
|
|
troponin I
Tidsram: before anesthesia, 24 hour after the end of anesthesia
|
before anesthesia, 24 hour after the end of anesthesia
|
|
C-reactive protein
Tidsram: before anesthesia, 24 hour after the end of anesthesia
|
before anesthesia, 24 hour after the end of anesthesia
|
|
serum creatinine
Tidsram: before anesthesia, 24 hour after the end of anesthesia
|
before anesthesia, 24 hour after the end of anesthesia
|
|
PaO2/FiO2 ratio
Tidsram: before anesthesia, 24 hour after the end of anesthesia
|
before anesthesia, 24 hour after the end of anesthesia
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KUH1160040
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