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

Официальное название

Estudo Randomizado de Cluster Escalonado Para Avaliar o Impacto de Uma Plataforma tecnológica Baseada no ERAS (Enhanced Recovery After Surgery) no Tempo de permanência após Cirurgia de revascularização miocárdica: Projeto Tempos Certos - REPLICCAR III

Обзор

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.

Вмешательства

• Другое ERACS with Digital Platform
  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 (psychological, nutritional, and others), scheduling and confirming hospital admission, and following specific protocols during surgery and intensive care. The app aims to enhance communication

Первичные конечные точки

• Lenght of Stay [Срок оценки: up to 30 days after surgery]

Вторичные конечные точки (4)

• Percentage of Completeness of Protocol Steps [Срок оценки: up to 01 week after surgery.]
• Morbility and Mortality [Срок оценки: up to 6 months after surgery]
• Patient-reported outcomes (PROM) [Срок оценки: up to 6 months after surgery]
• Patient reported experience measure(PREM) [Срок оценки: up to 6 months after surgery]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Бразилия · 2 центра

• InCor - Instituto do Coração do Hospital das Clínicas da FMUSP — São Paulo
• InCor - Instituto do Coração do Hospital das Clínicas da FMUSP — São Paulo

Публикации

• 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.pon PMID 41474739

Идентификаторы

NCT: NCT06786819 · 5811/24/022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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