Impact of a Technology Platform Based on Enhanced Recovery After(ERAS) Surgery on Length of Stay After Coronary Artery Bypass Grafting: Timely Project (REPLICCARIII)

University of Sao Paulo General Hospital

Status: Enrolling

Conditions: Cardiac Surgery; ERAS; Digital Health; Cardiac Surgery-CABG

Treatments: Other: ERACS with Digital Platform

Study type: Interventional

Funder types: Other

Identifiers

NCT06786819

5811/24/022

Details and patient eligibility

About

Cardiovascular diseases continue to be the leading cause of death worldwide. Among them, coronary artery disease has the greatest impact, being characterized as one of the main causes of death in Brazil over the last decade. One of the well-established treatments is coronary artery bypass grafting, which is the most performed among cardiac surgeries and, in our scenario, is primarily funded by the Unified Health System (SUS). The information obtained from the Paulista Registry of Cardiovascular Surgeries (REPLICCAR), in partnership with FAPESP, has been important for implementing improvements in the landscape of cardiac surgeries in the state of São Paulo. Although outcomes in cardiac surgery have improved due to the structuring and organization of quality programs, this is still not a reality at the national level. In a situation where data collection and quality initiatives play a central role in continuous improvement, generating value becomes essential for the sustainability of cardiac surgery programs. In this sense, the concept of Enhanced Recovery After Surgery (ERAS) has gained increasing traction. This concept is based on multidisciplinary protocols and scientific evidence, which help prepare patients for rapid recovery, resulting in reduced complications, shorter hospital stays, and, primarily, lower hospital costs. On the other hand, the increase in surgical waiting lists has also led to a rise in home mortality due to cardiac causes. Thus, among the various challenges imposed by the current scenario, the investigators believe that preparing patients for rapid recovery after coronary artery bypass grafting presents an opportunity for the sustainability of the healthcare system. Therefore, the aim of this project is to evaluate the impact of a technology platform based on ERAS on the postoperative recovery time of patients undergoing coronary artery bypass grafting in reference centers in the state of São Paulo, Timely Project - REPLICCAR III.

Enrollment: 480 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults over 18 years old
• Indication for primary isolated CABG (elective or urgent status)
• Own a personal cell phone
• Have internet access
• Knowledgeable in using the device
• Full understanding and agreement regarding the informed consent form (ICF)

Exclusion criteria

• Indication for associated surgery
• Glycosylated hemoglobin level greater than 8%
• Creatinine clearance less than 30 mL/min
• Pre-operative atrial fibrillation or use of pre-operative anticoagulation
• Hemoglobin less than 12 g/dL
• Users of illicit drugs
• STS score greater than 4%
• Physical or mental disabilities that prevent adherence to the protocol
• Refusal by the patient or family member

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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480 participants in 2 patient groups

Standard care for CABG

No Intervention group

Description:

Patients will be treated with CABG following the standard of care for each participant institution.

ERACS with Digital Platform

Experimental group

Description:

Patient will be treated by the participant institution following a modified protocol based in the ERACS with the aid of a digital platform.

Treatment:

Other: ERACS with Digital Platform