Cardiovascular DiseasePhase 4ulistinNCT01518569
Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery
A Phase 4 study testing ulinastatin in people with Cardiovascular Disease, run by Konkuk University Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- ulinastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2008to Aug 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective cardiac surgery employing CPB
Who cannot join
- urgent/emergency surgery,
- previous heart surgery,
- combined CABG and valve surgery,
- age > 75 yrs,
- left ventricular ejection fraction < 0.45,
- diabetes treated with insulin,
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Cardiovascular Disease
- Being tested
- ulinastatin, placebo
- Keywords
- ulinastatin, systemic inflammation, cardiac surgery, cardiopulmonary bypass
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ulinastatinDrug
Also called ulistin
ulinastatin 5000 unit/kg iv before the initiation of CPB
placeboDrug
Also called normall saline
placebo (the same amount of normal saline) iv before the initiation of CPB
| Study group | Role | What they receive |
|---|---|---|
| placebo | Placebo comparator | normal saline, same amount, iv Receives: Drug: placebo |
| ulinastatin | Active comparator | 5000 unit/kg iv Receives: Drug: ulinastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
bactericidal permeability increasing protein
Measured: 5-30 min before the end of anesthesia
interleukin-6
Measured: 5-30 min before the end of anesthesia
tumor necrosis factorTNF-α
Measured: 5-30 min before the end of anesthesia
Secondary outcomes (5)
Creatine kinase-MB
Measured: before anesthesia, 24 hour after the end of anesthesia
troponin I
Measured: before anesthesia, 24 hour after the end of anesthesia
C-reactive protein
Measured: before anesthesia, 24 hour after the end of anesthesia
serum creatinine
Measured: before anesthesia, 24 hour after the end of anesthesia
PaO2/FiO2 ratio
Measured: before anesthesia, 24 hour after the end of anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2012 (estimated)
- Study startMar 2008
- Primary completionJun 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae-Yop Kim, MD PhD, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01518569
- Sponsor's protocol ID
- KUH1160040
- Acronym
- ulistin
- Status last verified
- Jan 2012
- First submitted
- 20 Jan 2012
- Last updated
- 26 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16540949Hill GE. Cardiopulmonary bypass-induced inflammation: is it important? J Cardiothorac Vasc Anesth. 1998 Apr;12(2 Suppl 1):21-5.
PubMed 9583572
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ulinastatin on Postoperative Systemic Inflammatory Response in Cardiac Surgery
- ClinicalTrials.gov ID
- NCT01518569
- Acronym / sponsor ID
- ulistin / KUH1160040
- Conditions
- Cardiovascular Disease
- Keywords
- ulinastatin, systemic inflammation, cardiac surgery, cardiopulmonary bypass
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Konkuk University Medical CenterUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 26 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| placebo | Placebo comparator | Drug: placebonormal saline, same amount, iv |
| ulinastatin | Active comparator | Drug: ulinastatin5000 unit/kg iv |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective cardiac surgery employing CPB
Key exclusion criteria (12 listed)
- urgent/emergency surgery,
- previous heart surgery,
- combined CABG and valve surgery,
- age > 75 yrs,
- left ventricular ejection fraction < 0.45,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ulinastatinAlso: ulistinulinastatin 5000 unit/kg iv before the initiation of CPB | Drug | ulinastatin |
| placeboAlso: normall salineplacebo (the same amount of normal saline) iv before the initiation of CPB | Drug | placebo |
Primary outcome
bactericidal permeability increasing protein
Time frame: 5-30 min before the end of anesthesia
interleukin-6
Time frame: 5-30 min before the end of anesthesia
tumor necrosis factorTNF-α
Time frame: 5-30 min before the end of anesthesia
5 secondary outcomes
Creatine kinase-MB
Time frame: before anesthesia, 24 hour after the end of anesthesia
troponin I
Time frame: before anesthesia, 24 hour after the end of anesthesia
C-reactive protein
Time frame: before anesthesia, 24 hour after the end of anesthesia
serum creatinine
Time frame: before anesthesia, 24 hour after the end of anesthesia
PaO2/FiO2 ratio
Time frame: before anesthesia, 24 hour after the end of anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
- Background: PubMed 16540949Nakanishi 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.
- Background: PubMed 9583572Hill GE. Cardiopulmonary bypass-induced inflammation: is it important? J Cardiothorac Vasc Anesth. 1998 Apr;12(2 Suppl 1):21-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ulinastatin in people with Cardiovascular Disease, run by Konkuk University Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bactericidal permeability increasing protein (time frame: 5-30 min before the end of anesthesia). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01518569, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2012.