Evaluating a rapid recovery protocol for coronary artery bypass surgery
Prospective and Randomized Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery
This study tests a new recovery plan for people having heart surgery to see if it helps them get better faster compared to the usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06713096 on ClinicalTrials.gov |
What this trial studies
This trial aims to assess the effectiveness of a rapid recovery protocol for patients undergoing coronary artery bypass grafting (CABG) at a hospital in Brazil. It is a randomized and prospective study comparing outcomes between patients receiving the rapid recovery protocol and those following standard care. The primary focus is on postoperative hospital stay duration, while secondary objectives include evaluating morbidity, mortality, patient satisfaction, costs, and healthcare team adherence to the protocol. The study seeks to improve recovery outcomes for patients undergoing CABG.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old scheduled for elective or urgent isolated CABG.
Not a fit: Patients with severe ventricular dysfunction, renal impairment, or those requiring emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to shorter hospital stays and improved recovery experiences for patients undergoing CABG.
How similar studies have performed: Other studies have shown promising results with rapid recovery protocols in surgical settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (\>18 years old) * Undergoing isolated coronary artery bypass grafting (CABG) with elective or urgent status * Signed informed consent form (ICF) Exclusion Criteria: * Emergency patients * Severe ventricular dysfunction (ejection fraction \<30%) * Renal impairment (creatinine clearance \<30 mL/min) * Atrial fibrillation or need for oral anticoagulation * Moderate-to-severe anemia (hematocrit \<32%) * STS risk score \>4% * Patient and/or family disagreement with the protocol * Failure to sign the informed consent form
Where this trial is running
São Paulo, São Paulo
- Hc Da Fmusp Instituto Do Coracao Incor Sao Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Gabrielle B Borgomoni, bsc, PhD student — Instituto do coração
- Study coordinator: Omar A V Mejia, md, PhD
- Email: omarvmejia@gmail.com
- Phone: 555+(11) 2661-5014
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.