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New treatment option for Inflammatory Response
Official title Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery
ClinicalTrials.gov ID: NCT06118034
What this study is testing
What is Colchicine 0.5 MG?
Colchicine 0.5 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for inflammatory response.
Also referred to as Routine cardiovascular surgery and peri-operative management.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- All patients will be completed collection of demographic data, clinical data, and be observed for inflammatory organ damage, oxygenation index or SpO2/ FIO2, WBC, NEU, interleukin-1β, interleukin-6, interleukin-8 (IL-1β/6/8), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), procalcitonin (PCT), myoglobin (Myo), creatine kinase-MB (CK-MB), high-sensitivity cardiac troponin T (hs-cTnT), neutrophil elastase (NE), myeloperoxidase (MPO), APACHE II score, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, Murray lung injury score, serum creatinine, eGFR, mechanical ventilation time, ICU length of stay, drug-related gastrointestinal reactions, and 30-day and 90-day all-cause mortality, among other indicators.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 80
You may be able to join if
- Aged between 50 and 80 years, male or female;
- Patients undergoing elective cardiac surgery;
- Have signed the informed consent form (ICF).
You likely can't join if
- Patients undergoing emergency surgery;
- Patients undergoing deep hypothermic circulatory arrest surgery;
- Preoperative predicted mortality \>3% according to European System for Cardiac Operative Risk Evaluation II (EuroSCORE II);
- Patients undergoing off-pump coronary artery bypass grafting (off-pump CABG) surgery;
- Patients undergoing left or right ventricular outflow tract obstruction surgery;
- Patients undergoing complex corrective surgery for congenital heart disease;
See the full eligibility criteria
- Aged between 50 and 80 years, male or female;
- Patients undergoing elective cardiac surgery;
- Have signed the informed consent form (ICF).
- Patients undergoing emergency surgery;
- Patients undergoing deep hypothermic circulatory arrest surgery;
- Preoperative predicted mortality \>3% according to European System for Cardiac Operative Risk Evaluation II (EuroSCORE II);
- Patients undergoing off-pump coronary artery bypass grafting (off-pump CABG) surgery;
- Patients undergoing left or right ventricular outflow tract obstruction surgery;
- Patients undergoing complex corrective surgery for congenital heart disease;
- Patients with an expected CPB exceeding 180 minutes or an anticipated aortic cross-clamp time exceeding 120 minutes;
- Patients expected to have a postoperative endotracheal tube removal time exceeding 24 hours;
- Patients with prolonged fasting or inability to self-feed;
- A history of malignant tumor;
- Patients with unstable preoperative vital signs requiring intra-aortic balloon pump (IABP), extracorporeal membrane oxygenation (ECMO)assistance, or endotracheal tube-assisted ventilation;
- A history of cardiac surgery;
- Patients with preoperative gastrointestinal symptoms, such as nausea, vomiting and diarrhea;
- Patients with a history of dialysis before surgery;
- Patients with a history of atrial fibrillation before surgery;
- Patients on long-term hepatorenal protective medications;
- Patients with hepatic and renal insufficiency (Child-Pugh class B or C, estimated glomerular filtration rate \<35 mL/min/1.73 m2);
- Patients with abnormal baseline inflammatory markers [interleukin-6 (IL6) \>10 pg/mL, procalcitonin (PCT) \>0.5 ng/mL, C reactive protein (CRP) \>10 mg/L];
- Patients diagnosed with infectious diseases, inflammatory immune diseases, or tumor;
- Patients who have received immunosuppressive or anti-inflammatory treatment;
- Patients allergic or intolerant to colchicine;
- Breastfeeding or pregnant women;
- Other situations deemed inappropriate for participation in the study by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.