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Multicenter Study Pragmatic Clinical Trial
A pragmatic multi-center trial of goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery.
- MalbouissonLuiz Marcelo SáLMSDivisão de Anestesia, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Enéas Carvalho de Aguiar, 255 2° andar, Cerqueira César, 05403-900, São Paulo, SP, Brazil. luiz.malbouisson@hc.fm.usp.br., João Manoel Silva, CarmonaMaria José CarvalhoMJCDivisão de Anestesia, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Enéas Carvalho de Aguiar, 255 2° andar, Cerqueira César, 05403-900, São Paulo, SP, Brazil., Marcel Rezende Lopes, Murilo Santucci Assunção, Jorge Luís Dos Santos Valiatti, Claudia Marques Simões, and AulerJosé Otavio CostaJOCJrDivisão de Anestesia, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Enéas Carvalho de Aguiar, 255 2° andar, Cerqueira César, 05403-900, São Paulo, SP, Brazil..
- Divisão de Anestesia, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, Av. Enéas Carvalho de Aguiar, 255 2° andar, Cerqueira César, 05403-900, São Paulo, SP, Brazil. luiz.malbouisson@hc.fm.usp.br.
- BMC Anesthesiol. 2017 May 30; 17 (1): 70.
BackgroundIntraoperative fluid therapy guided by mechanical ventilation-induced pulse-pressure variation (PPV) may improve outcomes after major surgery. We tested this hypothesis in a multi-center study.MethodsThe patients were included in two periods: a first control period (control group; n = 147) in which intraoperative fluids were given according to clinical judgment. After a training period, intraoperative fluid management was titrated to maintain PPV < 10% in 109 surgical patients (PPV group). We performed 1:1 propensity score matching to ensure the groups were comparable with regard to age, weight, duration of surgery, and type of operation. The primary endpoint was postoperative hospital length of stay.ResultsAfter matching, 84 patients remained in each group. Baseline characteristics, surgical procedure duration and physiological parameters evaluated at the start of surgery were similar between the groups. The volume of crystalloids (4500 mL [3200-6500 mL] versus 5000 mL [3750-8862 mL]; P = 0.01), the number of blood units infused during the surgery (1.7 U [0.9-2.0 U] versus 2.0 U [1.7-2.6 U]; P = 0.01), the fraction of patients transfused (13.1% versus 32.1%; P = 0.003) and the number of patients receiving mechanical ventilation at 24 h (3.2% versus 9.7%; P = 0.027) were smaller postoperatively in PPV group. Intraoperative PPV-based improved the composite outcome of postoperative complications OR 0.59 [95% CI 0.35-0.99] and reduced the postoperative hospital length of stay (8 days [6-14 days] versus 11 days [7-18 days]; P = 0.01).ConclusionsIn high-risk surgeries, PPV-directed volume loading improved postoperative outcomes and decreased the postoperative hospital length of stay.Trial RegistrationClinicalTrials.gov Identifier; retrospectively registered- NCT03128190.
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