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

TY - JOUR

T1 - Individualized, perioperative, hemodynamic goal-directed therapy in major abdominal surgery (iPEGASUS trial): study protocol for a randomized controlled trial

AU - Funcke, Sandra

AU - Saugel, Bernd

AU - Koch, Christian

AU - Schulte, Dagmar

AU - Zajonz, Thomas

AU - Sander, Michael

AU - Gratarola, Angelo

AU - Ball, Lorenzo

AU - Pelosi, Paolo

AU - Spadaro, Savino

AU - Ragazzi, Riccardo

AU - Volta, Carlo Alberto

AU - Mencke, Thomas

AU - Zitzmann, Amelie

AU - Neukirch, Benedikt

AU - Azparren, Gonzalo

AU - Giné, Marta

AU - Moral, Vicky

AU - Pinnschmidt, Hans Otto

AU - Díaz-Cambronero, Oscar

AU - Estelles, Maria Jose Alberola

AU - Velez, Marisol Echeverri

AU - Montañes, Maria Vila

AU - Belda, Javier

AU - Soro, Marina

AU - Puig, Jaume

AU - Reuter, Daniel Arnulf

AU - Haas, Sebastian Alois

PY - 2018/5/9

Y1 - 2018/5/9

N2 - BACKGROUND: Postoperative 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/DESIGN: This 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.DISCUSSION: This is a large, international randomized controlled study evaluating the effect of perioperative, individualized, algorithm-driven ,hemodynamic optimization on postoperative morbidity and mortality.TRIAL REGISTRATION: Trial registration: NCT03021525 . Registered on 12 January 2017.

AB - BACKGROUND: Postoperative 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/DESIGN: This 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.DISCUSSION: This is a large, international randomized controlled study evaluating the effect of perioperative, individualized, algorithm-driven ,hemodynamic optimization on postoperative morbidity and mortality.TRIAL REGISTRATION: Trial registration: NCT03021525 . Registered on 12 January 2017.

KW - Journal Article

U2 - 10.1186/s13063-018-2620-9

DO - 10.1186/s13063-018-2620-9

M3 - SCORING: Journal article

C2 - 29743101

VL - 19

SP - 273

JO - TRIALS

JF - TRIALS

SN - 1745-6215

IS - 1

ER -