Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial

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.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2620-9) contains supplementary material, which is available to authorized users.

Perioperative non-invasive versus semi-invasive cardiac index monitoring in patients with bariatric surgery – a prospective observational study

“…Thus, we deliberately chose the semi-invasive pulse-contour analysis method as a reference. Alternative semi-invasive devices for non-calibrated pulse-contour analysis-based CO measurement are currently under investigation in the context of perioperative, individualized hemodynamic optimization in a large, international randomized controlled study [48]. A further limitation may be that the ipsilateral measurement of intra-arterial pressure from the reference radial line likely introduced bias for the finger cuff photopletysmography based measurements of the small finger arteries.…”

Multiparametric Monitoring of Hypnosis and Nociception-Antinociception Balance during General Anesthesia—A New Era in Patient Safety Standards and Healthcare Management

“…Won et al reported that using SPI monitoring during general anesthesia reduced opioid consumption, improved hemodynamic stability, and reduced postoperative recovery times [ 71 ]. A similar study was carried out by Jain et al, which showed a statistically significant decrease in the number of hemodynamic adverse events when SPI was used for the titration of opioid medication ( p < 0.05) [ 70 ].…”

“…Numerous studies have shown that opioid overdose during anesthesia is responsible for a series of adverse effects, such as increased recovery times and opioid induced hyperalgesia, and that opioid overdose also leads to hypotension, having a major impact on perioperative hemodynamic stability [ 66 , 67 , 68 , 69 , 70 , 71 ]. Won et al reported that using SPI monitoring during general anesthesia reduced opioid consumption, improved hemodynamic stability, and reduced postoperative recovery times [ 71 ].…”

An individualized hemodynamic optimization: Tailoring the targets of therapy

“…[ 5 ] They depicted a significantly decreased rate of postoperative complications. However, the individualized perioperative hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS) trial outlined a comparable complication rate following the GDT protocol of an individually optimized CO.[ 6 ] Ackland et al . emphasized the significance of an individualized oxygen delivery targeted hemodynamic management at alleviating postoperative morbidity following high-risk surgery.…”