Cardiac SurgeryNCT04028024
Protective Effect in Cardiac Surgery Patients
A study testing Ulinastatin in people with Cardiac Surgery, run by Shanghai Zhongshan Hospital.
Trial summary
The purpose of the study was to verify the protective effect of inhibiting systemic inflammatory response in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Ulinastatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to Jun 2021
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject needs to have valve surgery
- subject needs to have coronary artery bypass grafting surgery
- subject needs to have artificial blood vessel replacement surgery
- ASA(American Society of Anesthesiologists) score II~III
- NYHA(New York Heart Association) II~III
Who cannot join
- LVEF(left ventricular ejection fraction) <40% measured by echocardiogram
- history of myocardial infarction within 1 month
- history of serious pulmonary infection or endocarditis within 3 months
- history of important surgery within 6 months
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Study on the Protective Effect of Inhibiting Systemic Inflammatory Response in Patients Undergoing Cardiac Surgery.
The purpose of the study was to verify the protective effect of inhibiting systemic inflammatory response in patients undergoing cardiac surgery.
- Conditions
- Cardiac Surgery
- Being tested
- Ulinastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UlinastatinDrug
Ulinastatin 5000U/Kg in 20 ml NS i.v. before occlusion of aorta
| Study group | Role | What they receive |
|---|---|---|
| inhibiting systemic inflammatory response | Other | Ulinastatin 5000U/kg in 20ml NS i.v. before occlusion of aorta Receives: Drug: Ulinastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative delirium
the incidence of postoperative delirium
Measured: 7 days postoperatively or discharge, whichever came first
postoperative renal insufficiency
the incidence of renal insufficiency
Measured: 7 days postoperatively or discharge, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start1 Aug 2019 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-lin Wang, Phd, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028024
- Sponsor's protocol ID
- B2019-156
- Status last verified
- Jul 2019
- First submitted
- 14 Jul 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Protective Effect of Inhibiting Systemic Inflammatory Response in Patients Undergoing Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT04028024
- Acronym / sponsor ID
- B2019-156
- Conditions
- Cardiac Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 22 Jul 2019 (actual)
- 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 study was to verify the protective effect of inhibiting systemic inflammatory response in patients undergoing cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inhibiting systemic inflammatory response | Other | Drug: UlinastatinUlinastatin 5000U/kg in 20ml NS i.v. before occlusion of aorta |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- subject needs to have valve surgery
- subject needs to have coronary artery bypass grafting surgery
- subject needs to have artificial blood vessel replacement surgery
- ASA(American Society of Anesthesiologists) score II~III
- NYHA(New York Heart Association) II~III
Key exclusion criteria (4 listed)
- LVEF(left ventricular ejection fraction) <40% measured by echocardiogram
- history of myocardial infarction within 1 month
- history of serious pulmonary infection or endocarditis within 3 months
- history of important surgery within 6 months
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 |
|---|---|---|
| UlinastatinUlinastatin 5000U/Kg in 20 ml NS i.v. before occlusion of aorta | Drug | inhibiting systemic inflammatory response |
Primary outcome
postoperative delirium
Time frame: 7 days postoperatively or discharge, whichever came first
the incidence of postoperative delirium
postoperative renal insufficiency
Time frame: 7 days postoperatively or discharge, whichever came first
the incidence of renal insufficiency
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
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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.
Hui-lin Wang, Phd principal investigator
Fudan University
Questions about this trial
What is this clinical trial studying?
A study testing Ulinastatin in people with Cardiac Surgery, run by Shanghai Zhongshan Hospital.
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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ke-fang Guo, PhD (64041990, Guo.kefang@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative delirium (time frame: 7 days postoperatively or discharge, whichever came first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jul 2019; AzTrials last refreshed its copy on 29 Oct 2026.