CABG, CAD - Coronary Artery Disease, ERAS, Medicine, Chinese Traditional
Conditions
Keywords
CABG, ERAS, MICS-CABG, Chinese traditional medicine
Brief summary
This study aims to evaluate the efficacy and safety of Fuzheng Yangxin Formula (FZYXF) in the treatment of qi-yin deficiency syndrome after coronary artery bypass grafting (CABG), formulate an integrated Chinese and Western medicine rehabilitation protocol, develop special proprietary Chinese medicines for postoperative patients, establish a postoperative rehabilitation database, and promote the standardized application and achievement transformation of integrated Chinese and Western medicine therapy in cardiac surgery.
Detailed description
This study adopts a randomized controlled trial design. A total of 230 patients presenting with qi-yin deficiency syndrome after coronary artery bypass grafting (CABG) will be enrolled and randomly assigned to the Fuzheng Yangxin Formula (FZYXF) experimental group (115 patients) and the control group (115 patients). The primary outcome is the Seattle Angina Questionnaire (SAQ) score at 7 days after medication. Secondary outcomes include perioperative safety and follow-up health assessments to comprehensively evaluate the therapeutic efficacy and safety.
Interventions
DRUGFZYX
Intervention: Fuzheng Yangxin Formula granules combined with routine postoperative management. The formula consists of Radix Ginseng 20 g, processed Radix Aconiti Lateralis Preparata 10 g (pre-decocted), Radix Astragali 30 g, Radix Ophiopogonis 20 g, Radix Angelicae Sinensis 15 g, Radix Rehmanniae 15 g, Radix Rhodiolae 30 g, Radix Notoginseng powder 6 g (mixed with warm water for oral use). Participants take the granules orally for 7 consecutive days after CABG.
Sponsors
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
-Patients who have undergone coronary artery bypass grafting (CABG) and present with postoperative qi-yin deficiency syndrome.
Exclusion criteria
* Patients with hypersensitivity to any components of Fuzheng Yangxin Formula granules. * Patients with fever or common cold after surgery. * Patients with severe postoperative liver and kidney dysfunction. * Patients who receive concurrent valve surgery or other intracardiac operations * Patients with end-stage malignant tumors * Patients with uncontrolled infection or bleeding * Patients with progressive degenerative systemic diseases, such as severe trauma, multiple organ failure and other severe impairment of vital organ function including severely damaged liver function * Patients with severe heart failure or cardiogenic shock who cannot tolerate treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Score of physical activity limitation dimension in the Seattle Angina Questionnaire (SAQ) at 7 days after medication | 7 days after operation | Measured using the Seattle Angina Questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of Stay | Perioperative | The postoperative length of hospital stay |
| Follow-up Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) | up to 12 months | The incidence of MACCE, which includes all-cause mortality, repeat bypass surgery or stenting, acute myocardial infarction, and stroke. |
| Seattle Angina Questionnaire (SAQ) Scores | up to 12 months | Evaluation of the patient's health and angina status, including the total score and scores across 5 dimensions: physical limitation, angina stability, angina frequency, treatment satisfaction, and disease perception. |
| Incidence of poor wound healing. | up to 30 days | Assessed by routine postoperative clinical physical examination. A positive event is defined as the presence of any of the following: local wound dehiscence (splitting open), abnormal wound exudate (purulent or serous drainage), or the need for secondary surgical suturing/re-suturing. Number and percentage of participants with poor wound healing (number of events / total participants in group × 100%). |
| Perioperative MACCE | Perioperative | Composite endpoint before discharge, including death, myocardial infarction, stroke, and revascularization |
| Graft patency | perioperative | graft patency rate (assessed by angiography)，Using the Fitz-Gibbon grading system, grade A and grade B are considered patent. |
| atrial fibrillation incidence | perioperative | Monitor patients for atrial fibrillation during hospitalization; if it occurs, it is considered positive. |
| Renal failure | Perioperative | Patients who develop new-onset renal failure after surgery and require dialysis |
| reintubation | Perioperative | Reintubation and mechanical ventilation are required during the postoperative hospital stay |
| length of ICU stay. | perioperative | length of Intensive Care Unit (ICU) stay. |
Countries
China
Contacts
CONTACTGong Yichen, Doctor
CONTACTPeking University 3rd Hospital cardiac surgery
Outcome results
None listed