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Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery

Study to Evaluate the Impact of the Recovery Pathway on Postoperative Leght of Stay in Coronary Artery Bypass Surgery

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Phase N/A

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Overview

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

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

Study details
    Enhanced Recovery After Surgery
    Quality Improvement

NCT06713096

University of Sao Paulo General Hospital

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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