Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06118034
Status:
RECRUITING
Last Update Posted:
2024-05-21
First Post:
2023-10-24
Brief Title:
Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
Official Title:
Effect of Colchicine on Perioperative Anti-inflammatory Organ Injury in Cardiac Surgery a Multi-center Randomized Controlled Double-blind Clinical Trial
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-1β68 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
Detailed Description:
This study is a multicenter randomized controlled double-blind placebo- controlled clinical trial A total of 768 patients who met the inclusion and exclusion criteria and were scheduled for cardiac surgery under cardiopulmonary bypass were enrolled After signing informed consent patients were randomly divided into the experimental group and the control group Patients in the experimental group took 05mg of colchicine tablets orally for 3 days before surgery and continued to take 05mg daily for 10 days after tracheal extubation Patients in the control group received an equivalent amount of starch placebo tablets administered at the same times and in the same doses as the experimental group during the colchicineplacebo treatment period without affecting the patients standard treatment protocols
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-1β68 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 The study aims to investigate the impact of colchicine on the levels of inflammatory factors and prognosis in patients undergoing cardiac vascular surgery and to observe the potential organ damage to the heart lungs liver kidneys and the occurrence of adverse events such as leukopenia and thrombocytopenia This is done to assess the safety of colchicine use in cardiac surgery patients
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-1β68 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 The study aims to investigate the impact of colchicine on the levels of inflammatory factors and prognosis in patients undergoing cardiac vascular surgery and to observe the potential organ damage to the heart lungs liver kidneys and the occurrence of adverse events such as leukopenia and thrombocytopenia This is done to assess the safety of colchicine use in cardiac surgery patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None