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

NCT06786819 | Recruiting DMC

• 1 other identifier: 5811/24/022
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

Cardiac Surgery; CABG; ERASCS; ERAS; Digital Health

Outcome Measures

Primary Outcomes (1)

• Lenght of Stay

  Compare the length of stay after coronary artery bypass grafting (CABG) with versus without the use of a technology platform based on ERAS.

  up to 30 days after surgery

Secondary Outcomes (4)

• Percentage of Completeness of Protocol Steps

  up to 01 week after surgery.

• Morbility and Mortality

  up to 6 months after surgery

• Patient-reported outcomes (PROM)

  up to 6 months after surgery

• Patient reported experience measure(PREM)

  up to 6 months after surgery

Study Arms (2)

Standard care for CABG

NO INTERVENTION

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

ERACS with Digital Platform

EXPERIMENTAL

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

Other: ERACS with Digital Platform

Interventions

ERACS with Digital Platform OTHER

The assistance provided to patients in the intervention group will be sequential and prospective. The project will utilize an app based on protocols that prepare patients for rapid recovery (ERAS), starting before surgery and extending up to 30 days post-discharge. This includes pre-operative evaluations (dental, psychological, nutritional, and others), scheduling and confirming hospital admission, and following specific protocols during surgery and intensive care. The app aims to enhance communication and teamwork, improving patient-centered care. It will feature modules for patient and family education, team communication, and activity management through a dashboard. Additionally, it will facilitate interaction with patients through messages and surveys, monitor multidisciplinary team communication, and collect patient-reported outcomes 30 days after the surgical procedure.

Also known as: ERACS, Enhanced Recovery After Cardiac Surgery, Digital ERAS

ERACS with Digital Platform

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Instituto Dante Pazzanese de Cardiologia: collaborator
• Irmandade da Santa Casa de Misericordia de Sao Paulo: collaborator
• Instituto do Coração da Universidade de São Paulo, Brazil: collaborator
• Hospital Beneficence Portuguese of São Paulo: collaborator
• Irmandade Santa Casa Misericórdia Marília: collaborator
• Faculdade de Medicina do ABC: collaborator

Study Sites (2)

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, São Paulo, 05403-900, Brazil

RECRUITING

InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

São Paulo, São Paulo, 05403-900, Brazil

NOT YET RECRUITING

Related Publications (1)

• Borgomoni GB, Reis PH, Pinheiro G, Ribas FF, Silva GSD, Campagnucci VP, Issa M, Farsky PS, Barg MM, Tiveron MG, Dos Reis Falcao LF, Dias RD, Ferreira Lisboa LA, Jatene FB, Mejia OAV. The technological proposal based on enhanced recovery after cardiac surgery for changing traditional care in Latin America: REPLICCAR III Study Protocol. PLoS One. 2025 Dec 31;20(12):e0338301. doi: 10.1371/journal.pone.0338301. eCollection 2025.

  PMID: 41474739 DERIVED

Study Officials

• Omar A V Mejia, MD, PhD

  InCor - Instituto do Coração do Hospital das Clínicas da FMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Omar A V Mejia, MD, PhD

CONTACT

+551126615014; omarvmejia@incor.usp.br

Pedro H Reis, MD

CONTACT

+551126615014; pedro.reis@fm.usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator, Head of Quality Improvement in Cardiac Surgery

Model Details: Cluster Randomized Study

Study Record Dates

• First Submitted: November 7, 2024
• First Posted: January 22, 2025
• Study Start: March 10, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)