Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery

Launched by CANTONAL HOSPITAL OF ST. GALLEN · Feb 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called colchicine on patients who have a higher risk of heart problems and are scheduled to undergo major non-cardiac surgeries, like certain types of vascular, intraperitoneal, or orthopedic surgeries. The goal is to see if colchicine can help prevent heart injuries and serious cardiac events during and after surgery, as these issues can lead to complications or even death.

To participate in this trial, individuals must be at least 16 years old and meet specific criteria, such as having a history of heart disease or other cardiovascular risk factors. Participants will receive colchicine around the time of their surgery and will be monitored for any heart-related issues. It's important to know that certain individuals, such as those with severe kidney problems or those who have had allergic reactions to colchicine, will not be eligible for this study. Overall, this research aims to find new ways to protect patients' heart health during major surgeries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• undergoing major non-cardiac surgery in general anaesthesia will be included. Major non-cardiac surgery is defined as:
• • vascular surgery (with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies)
• • intraperitoneal surgery
• • intrathoracic surgery
• • major orthopaedic surgery (spinal surgery or joint replacement surgery)
• * at cardiovascular risk, defined as meeting at least 1 of the following 6 criteria:
• • preoperative n-terminal pro brain natriuretic peptide (NT-proBNP) ≥ 200 ng/l
• • history of coronary artery disease
• • history of peripheral vascular disease
• • history of stroke
• • undergoing major vascular surgery, with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies
• * fulfilment of any 3 of the 8 following criteria:
• • undergoing major surgery (intrathoracic, intraperitoneal or supra-inguinal vascular surgery)
• • any history of congestive heart failure or history of pulmonary oedema
• • anamnestic transient ischemic attack (TIA)
• • diabetes under treatment with either oral antidiabetic agent or insulin
• • age \> 70 years
• • history of hypertension
• • serum creatinine \> 175 mumol/l or calculated creatinine clearance \< 60 ml/min/1.73m2 (cockcroft gault)
• • history of smoking within 2 years of surgery
• • planned surgical time ≥ 90 minutes
• • planned postoperative hospital stay at least 1 night
• Exclusion Criteria:
• • no written consent
• • inclusion in other clinical trial with direct impact on perioperative medication
• • previously reported side effects or reported intolerance from colchicine (e.g., allergic reaction or significant sensitivity to colchicine or an auxiliary substance of the IMP)
• • pregnancy or planned pregnancy and/or breast feeding
• • clinically significant history of drug or alcohol abuse within the last year
• • very severe frailty (≥ 8 clinical frailty scale)
• • patient with inflammatory bowel disease (e.g., Morbus Crohn or Colitis ulcerosa)
• • patient taking colchicine for other indications (e.g., familial Mediterranean fever, gout)
• • severe renal impairment (eGFR \< 30 ml min -1 1.73 m2 -1) or end-stage renal disease with indication for haemodialysis
• • history of solid organ or bone marrow transplantation
• • systemic immune-suppression (medication (steroids \>30mg cortisol-equivalent per day, tacrolimus etc...) or disease (e.g., myelodysplastic syndrome)
• • severe hepatic impairment with history of cirrhosis
• • chronic active hepatitis or functional disorders defined as alanine aminotransferase greater than three times the upper limit of normal
• • anticipated post-operative administration of CYP3A4 metabolized substances like cyclosporine, ketoconazole, clarithromycin, verapamil, quinidine, diltiazem or ritonavir
• • Any other condition that the investigator would consider a risk to the patient if the latter were to participate in the study.