Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery : a Multi-center, Randomized, Controlled, Double-blind Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 80
Healthy Volunteers: f
View:

• Aged between 50 and 80 years, male or female;

• Patients undergoing elective cardiac surgery;

• Have signed the informed consent form (ICF).

Locations
Other Locations
China
Dong-Jin Wang
RECRUITING
Nanjing
Contact Information
Primary
Tuo Pan, MD
pan_tuo@126.com
+8615205160210
Backup
Dongjin Wang, MD
Dongjin_wang@126.com
Time Frame
Start Date: 2024-01-28
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 768
Treatments
Experimental: Experimental group (colchicine group)
The experimental group take 0.5mg of colchicine tablets orally for 3 days before surgery, and continue to take 0.5mg every other day (qod) for 10 days after tracheal extubation.
Placebo_comparator: Control group
The control group take 0.5mg of placebo tablets orally for 3 days before surgery, and continue to take 0.5mg every other day (qod) for 10 days after tracheal extubation.
Related Therapeutic Areas
Sponsors
Collaborators: Affiliated Hospital of Nantong University, The First Affiliated Hospital of Shihezi University Medical College, The First People's Hospital of Huai'an, The First People's Hospital of Changzhou, The Affiliated Hospital of Yangzhou University, First Affiliated Hospital of Zhejiang University, Jinan Central Hospital, Xinhua hospital of ILi in Kazakhstan automomous district, First Affiliated Hospital of Harbin Medical University, Shandong Provincial Hospital
Leads: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

This content was sourced from clinicaltrials.gov