Perioperative goal-directed therapy in high-risk abdominal surgery. A multicenter randomized controlled superiority trial |
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| Affiliation: | 1. Department of Anesthesiology, University Medical Center Utrecht, Utrecht, the Netherlands;2. Department of Anesthesiology and Intensive Care, Albert Schweitzer Hospital, Dordrecht, the Netherlands;3. Department of Anesthesiology, University Medical Center Groningen, Groningen, the Netherlands;4. Department of Anesthesiology, Maastricht University Medical Center, Maastricht, the Netherlands;5. Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, the Netherlands;6. Department of Anesthesiology and Intensive Care, Catharina Ziekenhuis, Eindhoven, the Netherlands;1. Department of Health Sciences, University of Milan, Milan, Italy;2. Department of Critical and Supportive Therapy, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;4. Department of Recreation and Health-Care Management, Chia-Nan University of Pharmacy and Science, Tainan, Taiwan;1. Department of Anesthesiology, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China;2. Department of Anesthesiology, Yancheng Third People''s Hospital, Yancheng, Jiangsu, China;3. Department of Cardiovascular Surgery, First Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China;4. Department of Anesthesiology, University of Utah Health, Salt Lake City, UT, USA;5. Transitional Residency Program, Intermountain Medical Center, Murray, UT, USA;6. Department of Anesthesiology and Pain Medicine, University of California Davis Health, Sacramento, CA, USA;1. Icahn School of Medicine at Mount Sinai, New York, NY, United States of America;2. Department of Anesthesiology, Pain, and Perioperative Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America;1. Department of Anesthesiology, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China;2. Department of Anesthesiology, Hospital of Integrated Traditional Chinese and Western Medicine of Liangshan Prefecture, Liangshan 615000, Sichuan, China;3. Department of Thoracic Surgery, West China Hospital, Sichuan University, Chengdu 610041, Sichuan, China;1. Complutense University of Madrid and Department of Anesthesia, Hospital Universitario Infanta Leonor, Gran Vía del Este 80, 28031 Madrid, Spain;2. Department of Anesthesia, Center of Vascular and Thoracic Surgery and Intensive Care, Örebro University Hospital, Sweden;3. Department of Anesthesia, Hospital Universitario la Paz, Paseo de la Castellana, 261, 28046 Madrid, Spain;4. Zaragoza University and Department of Anesthesia, Hospital Clínico Universitario Lozano Blesa, Avenida San Juan Bosco, 15, 50009 Zaragoza, Spain;5. Complutense University of Madrid and Department of Preventive Medicine and Public Health, Hospital Clinico San Carlos, Prof Martin Lagos s/n, 28040 Madrid, Spain;6. Complutense University of Madrid and Department of Anesthesia, Hospital Clinico San Carlos, Prof Martin Lagos s/n, 28040 Madrid, Spain;7. EAR (Evidence Anesthesia Review) Group |
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| Abstract: | ![]()
Study objectiveThe potential of perioperative goal-directed therapy (PGDT) to improve outcome after high-risk abdominal surgery remains subject of debate. In particular, there is a need for large, multicenter trials focusing on relevant patient outcomes to confirm the evidence found in small, single center studies including minor complications in their composite endpoints. The present study therefore aims to investigate the effect of an arterial waveform analysis based PGDT algorithm on the incidence of major complications including mortality after high-risk abdominal surgery.DesignProspective randomized controlled multicenter trial.SettingOperating theatres and Post-Anesthesia/Intensive Care units (PACU/ICU) of four tertiary hospitals in The Netherlands.PatientsA total number of 482 patients undergoing elective, abdominal surgery that is considered high-risk due to the extent of the procedure and/or patient comorbidities.InterventionsHemodynamic therapy using an age-specific PGDT algorithm including cardiac index (CI) and stroke volume variation (SVV) measurements during a 24-h perioperative period starting at induction of anesthesia.MeasurementsThe average number of major complications (including mortality) within 30 days after surgery, the number of minor complications, hospital and PACU/ICU length of stay (LOS), amounts of fluids and vasoactive medications used. Complications were graded using the Accordion severity grading system.ResultsThe average number of major complications per patient was 0.79 (PGDT group) versus 0.69 (control group) (p = 0.195). There were no statistically significant differences in the number of minor complications, hospital LOS, PACU/ICU LOS, or grading of complications. Patients in the PGDT group received more fluids intraoperatively, more dobutamine intra- and postoperatively, while patients in the control group received more phenylephrine during the operation.ConclusionsPGDT based on a CI and SVV driven algorithm did not result in improved outcomes after high-risk abdominal surgery.Clinical trial registrationNetherlands Trial Registry: NTR3380. |
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