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Completed

NCT Number: NCT01518569

Ulinastatin's Anti-inflammatory Reaction 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.

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Key information

Age range

25 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Konkuk University Medical Center

Seoul, 143-729, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ulinastatin

Drug

ulinastatin 5000 unit/kg iv before the initiation of CPB

Other names: ulistin

Placebo

Drug

placebo (the same amount of normal saline) iv before the initiation of CPB

Other names: normall saline

Primary outcomes

  1. bactericidal permeability increasing protein

    Time frame: 5-30 min before the end of anesthesia

  2. interleukin-6

    Time frame: 5-30 min before the end of anesthesia

  3. tumor necrosis factorTNF-α

    Time frame: 5-30 min before the end of anesthesia

Secondary outcomes

  1. Creatine kinase-MB

    Time frame: before anesthesia, 24 hour after the end of anesthesia

  2. troponin I

    Time frame: before anesthesia, 24 hour after the end of anesthesia

  3. C-reactive protein

    Time frame: before anesthesia, 24 hour after the end of anesthesia

  4. serum creatinine

    Time frame: before anesthesia, 24 hour after the end of anesthesia

  5. PaO2/FiO2 ratio

    Time frame: before anesthesia, 24 hour after the end of anesthesia

Sponsors and collaborators

Lead sponsor

Konkuk University Medical Center

Other

Registry information

Official study title

Effect of Ulinastatin on Postoperative Systemic Inflammatory Response in Cardiac Surgery

Acronym: ulistin

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jan 26, 2012
Registry last updated
Jan 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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