Study of Sivelestat Sodium in OPCABG
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAffiliated Hospital of Nantong University
About this trial
The goal of this clinical trial is to learn if drug Sivelestat Sodium works to improve the prognosis of off-pump coronary artery bypass grafting (OPCABG) in adults. It will also learn about the safety of drug Sivelestat Sodium. The main questions it aims to answer are:
* Does drug Sivelestat Sodium have a protective effect on myocardial injury after OPCABG? * Does Sivelestat Sodium exert a protective effect on myocardial inflammatory stress after OPCABG? Researchers will compare drug Sivelestat Sodium to a placebo (a look-alike substance that contains no drug) to see if drug Sivelestat Sodium works to protect myocardium following OPCABG.
Participants will:
* Accept drug Sivelestat Sodium injection or a placebo 2 h after OPCABG for 72 h. * Undergo a series of blood tests and echocardiography examinations after the OPCABG.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Undergoing elective OPCABG (≥2 bridged vessels). LVEF≥35%, no severe liver or kidney function abnormalities (ALT/AST≤3 times the upper limit, eGFR≥60 mL/min). Sign the informed consent form.
Disqualifiers
Emergency operation, combined valve surgery or aortic surgery. Usage of immunosuppressants or potent anti-inflammatory drugs within 30 days before the operation.
Active infections, autoimmune diseases, and allergy history.
Preoperative liver and kidney dysfunction
Severe cardiopulmonary insufficiency before the operation.
Trial design
Design model
Parallel
Treatments tested in this trial
Sivelestat Sodium injection 2 h after OPCABG for 72 h
DrugSivelestat Sodium injection 2 h after OPCABG for 72 h
Saline (0.9% NaCl)
DrugSaline (0.9% NaCl) instead of Sivelestat
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Sivelestat SodiumExperimental treatment 1 intervention
Group B: Routine therapyPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Myocardial injury
Sivelestat Sodium exerts a protective effect on myocardial injury after OPCABG
Time frame
Day 3 after OPCABGSecondary outcomes
1
Myocardial inflammatory stress
Sivelestat Sodium exerts a protective effect on myocardial inflammatory stress after OPCABG
Time frame
Day 3 after OPCABGSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov