NCT06118034

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
768

participants targeted

Target at P75+ for phase_3

Timeline
8mo left

Started Jan 2024

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Jan 2024Dec 2026

First Submitted

Initial submission to the registry

October 24, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 28, 2024

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

November 17, 2025

Status Verified

October 1, 2025

Enrollment Period

2.6 years

First QC Date

October 24, 2023

Last Update Submit

November 13, 2025

Conditions

Inflammatory ResponseCardiac Disease

Outcome Measures

Primary Outcomes (4)

  • Number of Participants with POAF

    POAF: Onset of new atrial fibrillation in patients within 10 days post-surgery.

    postoperative 10 days

  • Number of Participants with PMI

    PMI: Patient's high-sensitivity cardiac troponin T (hs-cTnT) exceeds 0.8 ng/L on the first day after surgery, and there is an increase of 10% or more on the second day compared to the first day postoperatively.

    postoperative 10 days

  • Number of Participants with ARDS

    ARDS: Acute Respiratory Distress Syndrome

    postoperative 10 days

  • Number of Participants with PPS

    PPS: post-pericardiotomy syndrome

    postoperative 10 days

Secondary Outcomes (16)

  • Oxygenation index

    postoperative day 1, 3, 5 and 7

  • Inflammatory index

    postoperative day 1, 3, 5 and 7

  • Myocardial injury marker

    postoperative day 1, 3, 5 and 7

  • Acute physiology and chronic health evaluation(APACHE II) socre

    postoperative day 1, 3, 5 and 7

  • Murray lung injury score

    postoperative day 1, 3, 5 and 7

  • +11 more secondary outcomes

Study Arms (2)

Experimental group (colchicine group)

EXPERIMENTAL

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.

Drug: Colchicine 0.5 MG

Control group

PLACEBO COMPARATOR

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.

Drug: Placebo

Interventions

Colchicine 0.5 MGDRUG

Take 0.5mg of colchicine tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation.

Also known as: Routine cardiovascular surgery and peri-operative management
Experimental group (colchicine group)
PlaceboDRUG

Take 0.5mg of starch tablets orally for 3 days before surgery, and continued to take 0.5mg every other day (qod) for 10 days after tracheal extubation.

Also known as: Routine cardiovascular surgery and peri-operative management
Control group

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 50 and 80 years, male or female;
  • Patients undergoing elective cardiac surgery;
  • Have signed the informed consent form (ICF).

You may not qualify 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;
  • 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;
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dong-Jin Wang

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (1)

  • Li X, Luo Y, Cai X, Lv Z, Kong Y, Guo Q, Zhu J, Pan T, Wang D. Anti-inflammatory effect of colchicine on organ damage during the perioperative period of cardiac surgery: a study protocol for a multicentre, randomised, double-blind, placebo-controlled clinical trial. BMJ Open. 2024 Sep 12;14(9):e084368. doi: 10.1136/bmjopen-2024-084368.

    PMID: 39266309DERIVED

MeSH Terms

Conditions

Heart Diseases

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Tuo Pan, M.D

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    STUDY DIRECTOR

  • DongJin Wang, M.D

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    STUDY CHAIR

  • DongJin Wang, M.D

    The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuo Pan, MD

CONTACT

+8615205160210pan_tuo@126.com

Dongjin Wang, MD

CONTACT

Dongjin_wang@126.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2023

First Posted

November 7, 2023

Study Start

January 28, 2024

Primary Completion (Estimated)

August 31, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

November 17, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)