Goal-directed therapy with continuous SvcO2 monitoring in pediatric cardiac surgery: the PediaSat single-center randomized trial
Terapia guiada por metas com monitoramento contínuo da SvcO₂ em cirurgia cardíaca pediátrica: ensaio randomizado PediaSat em centro único
Flavio M. Ferreira, David D. Araujo, Gustavo M. Dantas, Ligia Cristina C. Cunha, Suely P. Zeferino, Filomena B. Galas
Abstract
Introduction
Low Cardiac Output Syndrome (LCOS) remains a significant perioperative challenge in pediatric cardiac surgery. This study evaluated whether a hemodynamic protocol aimed at optimizing continuous central venous Oxygen Saturation (SvcO2) using the PediaSat catheter could reduce postoperative complications in pediatric patients undergoing congenital heart surgery.
Methods
Conducted at the Instituto do Coração in São Paulo, this randomized clinical trial compared a group receiving SvcO2-based goal-directed therapy via PediaSat (intervention) against conventional care (control). The main objective was assessing 24-hour lactate clearance post-surgery, with secondary outcomes including Vasoactive-Inotropic Score (VIS), Mechanical Ventilation (MV) duration, vasopressor use, and ICU/hospital stay lengths.
Results
From July 13, 2014, to March 17, 2016, 391 patients were evaluated for eligibility. After applying inclusion and exclusion criteria, 65 patients were included and randomized ‒ 33 to the control group and 32 to the PediaSat group. There were no losses to follow-up in either group. Lactate clearance did not significantly differ between the intervention and control groups. However, the PediaSat group showed significantly shorter mechanical ventilation times, reduced vasopressor use, and shorter ICU stays. No significant differences were observed in hospital stay length or incidence of postoperative complications between the group.
Conclusion
While optimizing SvcO2 did not affect overall lactate clearance, it was associated with shorter MV duration, decreased vasopressor need, and shorter ICU stays in pediatric cardiac surgery patients. These findings highlight the potential benefits of continuous SvcO2 monitoring in postoperative care.
Keywords
Resumo
Introdução
A Síndrome do Baixo Débito Cardíaco (LCOS) permanece um desafio perioperatório significativo na cirurgia cardíaca pediátrica. Este estudo avaliou se um protocolo hemodinâmico voltado para otimizar a saturação contínua de oxigênio venoso central (SvcO₂) usando o cateter PediaSat poderia reduzir complicações pós-operatórias em pacientes pediátricos submetidos à cirurgia cardíaca congênita.
Métodos
Realizado no Instituto do Coração em São Paulo, este ensaio clínico randomizado comparou um grupo que recebeu terapia guiada por metas baseada em SvcO₂ via PediaSat (intervenção) com cuidados convencionais (controle). O objetivo principal foi avaliar a depuração de lactato nas 24 horas após a cirurgia, com desfechos secundários incluindo o Vasoactive-Inotropic Score (VIS), duração da ventilação mecânica (MV), uso de vasopressores e tempo de permanência na UTI e no hospital.
Resultados
De 13 de julho de 2014 a 17 de março de 2016, 391 pacientes foram avaliados para elegibilidade. Após aplicação dos critérios de inclusão e exclusão, 65 pacientes foram incluídos e randomizados — 33 para o grupo controle e 32 para o grupo PediaSat. Não houve perdas de seguimento em nenhum dos grupos. A depuração de lactato não apresentou diferença significativa entre os grupos intervenção e controle. No entanto, o grupo PediaSat apresentou tempos significativamente menores de ventilação mecânica, redução no uso de vasopressores e menor permanência na UTI. Não foram observadas diferenças significativas no tempo de internação hospitalar ou na incidência de complicações pós-operatórias entre os grupos.
Conclusão
Embora a otimização da SvcO₂ não tenha afetado a depuração geral do lactato, ela esteve associada a uma menor duração da ventilação mecânica, redução na necessidade de vasopressores e permanência mais curta na UTI em pacientes submetidos à cirurgia cardíaca pediátrica. Esses achados ressaltam os potenciais benefícios do monitoramento contínuo da SvcO₂ no cuidado pós-operatório.
Palavras-chave
References
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Submitted date:
08/24/2024
Accepted date:
02/23/2025
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