NCT06713096 Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery
| NCT ID | NCT06713096 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Sao Paulo General Hospital |
| Condition | Enhanced Recovery After Surgery |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2021-11-25 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 128 participants in total. It began in 2021-11-25 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This randomized and prospective trial aims to evaluate the implementation of a rapid recovery protocol for coronary artery bypass grafting (CABG) in a hospital serving patients from the Brazilian Unified Health System (Sistema Único de Saúde - SUS). The study will compare outcomes between two groups: patients receiving care under the rapid recovery protocol and those following the standard institutional care. Primary Objective: Compare postoperative hospital stay between the rapid recovery group and the usual care group. Secondary Objectives: Assess morbidity and mortality between both groups. Evaluate patient satisfaction using validated tools. Analyze incremental costs associated with both approaches. Assess healthcare teams' learning progression regarding the protocol (Kirkpatrick method). Evaluate adherence to rapid recovery protocol metrics by healthcare teams. Measure changes in patient safety culture among healthcare professionals. Hypothesis: The null hypothesis assumes no difference in hospital stay between the two groups. The alternative hypothesis suggests that the rapid recovery protocol will reduce hospital stay compared to the standard care. Previous findings from Mejia et al. (2022) indicated a 40% reduction in postoperative hospital stay (from 13 to 7.8 days) for cardiac surgery patients under a rapid recovery protocol at the Heart Institute (InCor HCFMUSP). This trial will provide critical insights into the applicability of enhanced recovery after surgery (ERAS) principles in cardiac surgery within the context of public healthcare, aiming to improve outcomes and optimize resource use.
Eligibility 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
Contact & Investigator
Gabrielle B Borgomoni, bsc, PhD student
PRINCIPAL INVESTIGATOR
Instituto do coração
Frequently Asked Questions
Who can join the NCT06713096 clinical trial?
This trial is open to participants of all sexes, studying Enhanced Recovery After Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06713096 currently recruiting?
Yes, NCT06713096 is actively recruiting participants. Contact the research team at omarvmejia@gmail.com for enrollment information.
Where is the NCT06713096 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06713096 clinical trial?
NCT06713096 is sponsored by University of Sao Paulo General Hospital. The principal investigator is Gabrielle B Borgomoni, bsc, PhD student at Instituto do coração. The trial plans to enroll 128 participants.