Abstract
BackgroundPostoperative morbidity and mortality in patients undergoing surgery is high, especially in patients who are at risk of complications and undergoing major surgery. We hypothesize that perioperative, algorithm-driven, hemodynamic therapy based on individualized fluid status and cardiac output optimization is able to reduce mortality and postoperative moderate and severe complications as a major determinant of the patients’ postoperative quality of life, as well as health care costs.Methods/designThis is a multi-center, international, prospective, randomized trial in 380 patients undergoing major abdominal surgery including visceral, urological, and gynecological operations. Eligible patients will be randomly allocated to two treatment arms within the participating centers. Patients of the intervention group will be treated perioperatively following a specific hemodynamic therapy algorithm based on pulse-pressure variation (PPV) and individualized optimization of cardiac output assessed by pulse-contour analysis (ProAQT© device; Pulsion Medical Systems, Feldkirchen, Germany). Patients in the control group will be treated according to standard local care based on established basic hemodynamic treatment. The primary endpoint is a composite comprising the occurrence of moderate or severe postoperative complications or death within 28 days post surgery. Secondary endpoints are: (1) the number of moderate and severe postoperative complications in total, per patient and for each individual complication; (2) the occurrence of at least one of these complications on days 1, 3, 5, 7, and 28 in total and for every complication; (3) the days alive and free of mechanical ventilation, vasopressor therapy and renal replacement therapy, length of intensive care unit, and hospital stay at day 7 and day 28; and (4) mortality and quality of life, assessed by the EQ-5D-5L™ questionnaire, after 6 months.DiscussionThis is a large, international randomized controlled study evaluating the effect of perioperative, individualized, algorithm-driven ,hemodynamic optimization on postoperative morbidity and mortality.Trial registrationTrial registration: NCT03021525. Registered on 12 January 2017.
Highlights
Postoperative morbidity and mortality in patients undergoing surgery is high, especially in patients who are at risk of complications and undergoing major surgery
This is a large, international randomized controlled study evaluating the effect of perioperative, individualized, algorithm-driven,hemodynamic optimization on postoperative morbidity and mortality
Justification of the study The present study aims to evaluate the impact of perioperative, algorithm-driven, hemodynamic therapy based on individualized fluid status and individualized cardiac output optimization on postoperative moderate and severe complications and mortality
Summary
Reduction of perioperative mortality and morbidity is greatly required due to the massive benefit for the patients and the health care system. In a recent multi-center trial the achievement of adequate preoperative oxygen delivery was associated with a lower postoperative morbidity compared to the standard of care [25] In this context a various number of meta-analyses evaluating the impact of hemodynamic goal-directed therapy, and thereby optimizing oxygen supply, have already demonstrated reduction of morbidity in patients undergoing high-risk surgery [12,13,14,15,16,17]. The iPEGASUS trial further develops the concept of hemodynamic goal-directed therapy to individually set goals and is designed to assess its impact on mortality and morbidity Appendix These are the collaborators in the European centers initiated for patient recruitment and enrollment: 1.
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