Actively Recruiting
Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2025-11-17
768
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
Sponsors
T
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Lead Sponsor
F
First Affiliated Hospital of Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 50 and 80 years, male or female
- Patients undergoing elective cardiac surgery
- Have signed the informed consent form (ICF)
You will not qualify if you...
- Patients undergoing emergency surgery
- Patients undergoing deep hypothermic circulatory arrest surgery
- Preoperative predicted mortality >3% according to EuroSCORE II
- Patients undergoing off-pump coronary artery bypass grafting surgery
- Patients undergoing left or right ventricular outflow tract obstruction surgery
- Patients undergoing complex corrective surgery for congenital heart disease
- Patients with expected cardiopulmonary bypass exceeding 180 minutes or aortic cross-clamp time exceeding 120 minutes
- Patients expected to have postoperative endotracheal tube removal time exceeding 24 hours
- Patients with prolonged fasting or inability to self-feed
- History of malignant tumor
- Patients with unstable preoperative vital signs requiring IABP, ECMO, or endotracheal tube ventilation
- History of cardiac surgery
- Patients with preoperative gastrointestinal symptoms such as nausea, vomiting, or diarrhea
- History of dialysis before surgery
- 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, eGFR <35 mL/min/1.73 m2)
- Patients with abnormal baseline inflammatory markers (IL-6 >10 pg/mL, PCT >0.5 ng/mL, 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 by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Dong-Jin Wang
Nanjing, Jiangsu, China, 210008
Actively Recruiting
Research Team
T
Tuo Pan, MD
CONTACT
D
Dongjin Wang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here