NCT01518569

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2012

Completed
Last Updated

January 26, 2012

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

January 20, 2012

Last Update Submit

January 25, 2012

Conditions

Cardiovascular Disease

Keywords

ulinastatinsystemic inflammationcardiac surgerycardiopulmonary bypass

Outcome Measures

Primary Outcomes (3)

  • bactericidal permeability increasing protein

    5-30 min before the end of anesthesia

  • interleukin-6

    5-30 min before the end of anesthesia

  • tumor necrosis factorTNF-α

    5-30 min before the end of anesthesia

Secondary Outcomes (5)

  • Creatine kinase-MB

    before anesthesia, 24 hour after the end of anesthesia

  • troponin I

    before anesthesia, 24 hour after the end of anesthesia

  • C-reactive protein

    before anesthesia, 24 hour after the end of anesthesia

  • serum creatinine

    before anesthesia, 24 hour after the end of anesthesia

  • PaO2/FiO2 ratio

    before anesthesia, 24 hour after the end of anesthesia

Study Arms (2)

placebo

PLACEBO COMPARATOR

normal saline, same amount, iv

Drug: placebo

ulinastatin

ACTIVE COMPARATOR

5000 unit/kg iv

Drug: ulinastatin

Interventions

ulinastatinDRUG

ulinastatin 5000 unit/kg iv before the initiation of CPB

Also known as: ulistin
ulinastatin
placeboDRUG

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

Also known as: normall saline
placebo

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • elective cardiac surgery employing CPB

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Medical Center

Seoul, Seoul, 143-729, South Korea

Location

Related Publications (2)

  • 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.

    PMID: 16540949BACKGROUND

  • Hill GE. Cardiopulmonary bypass-induced inflammation: is it important? J Cardiothorac Vasc Anesth. 1998 Apr;12(2 Suppl 1):21-5.

    PMID: 9583572BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

urinastatin

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anesthesiology

Study Record Dates

First Submitted

January 20, 2012

First Posted

January 26, 2012

Study Start

March 1, 2008

Primary Completion

June 1, 2008

Study Completion

August 1, 2008

Last Updated

January 26, 2012

Record last verified: 2012-01

Locations

KR(1)