Xin-Qi Cheng1, Jun-Yan Zhang2, Hao Wu3, You-Mei Zuo3, Li-Li Tang3, Qing Zhao3, Er-Wei Gu4. 1. Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. Electronic address: ay_mz_cheng@126.com. 2. Department of Pharmacology, Anhui Medical University, 230032 Hefei, China. 3. Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. 4. Department of Anesthesiology, First Affiliated Hospital of Anhui Medical University, 230022 Hefei, China. Electronic address: ay_guew_mz@163.com.
Abstract
STUDY OBJECTIVE: To investigate whether optimizing individualized goal-directed therapy (GDT) based on cerebral oxygen balance in high-risk surgical patients would reduce postoperative morbidity. DESIGN: This was a prospective, randomized, controlled study. SETTING: The study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018. PATIENTS: 146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled. INTERVENTION: Patients were randomized to an individualized GDT group or usual care group. Individualized GDT was targeted to achieve the following goals: A less than 20% decline in the regional cerebral oxygen saturation (rScO2) level from baseline; a less than 20% decline in the mean arterial pressure (MAP) from baseline, as well as a bispectral index (BIS) of 45-60 before and after CPB and 40-45 during CPB. MEASUREMENTS: The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications. MAIN RESULTS: 128 completed the trial and were included in the modified intention-to-treat analysis. Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15). Secondary analysis showed that 75 (59%) of 128 patients achieved individual targets (irrespective of intervention) and sustained less morbidity (relative risk 3.41, 95% CI 2.19-5.31; P < 0.001). CONCLUSIONS: In high-risk patients undergoing cardiac surgery, individualized GDT therapy did not yield better outcomes, however, the achievement of preoperative individual targets may be associated with less morbidity. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03103633. Registered on 1 April 2017.
RCT Entities:
STUDY OBJECTIVE: To investigate whether optimizing individualized goal-directed therapy (GDT) based on cerebral oxygen balance in high-risk surgical patients would reduce postoperative morbidity. DESIGN: This was a prospective, randomized, controlled study. SETTING: The study was performed in the First Affiliated Hospital of Anhui Medical University, Hefei, China, from April 2017 to July 2018. PATIENTS: 146 high-risk adult patients undergoing valve replacements or coronary artery bypass surgery with cardiopulmonary bypass (CPB) were enrolled. INTERVENTION: Patients were randomized to an individualized GDT group or usual care group. Individualized GDT was targeted to achieve the following goals: A less than 20% decline in the regional cerebral oxygen saturation (rScO2) level from baseline; a less than 20% decline in the mean arterial pressure (MAP) from baseline, as well as a bispectral index (BIS) of 45-60 before and after CPB and 40-45 during CPB. MEASUREMENTS: The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications. MAIN RESULTS: 128 completed the trial and were included in the modified intention-to-treat analysis. Early morbidity was similar between the GDT (25 [39%] of 65 patients) and usual care groups (33 [53%] of 63 patients) (relative risk 0.73, 95% CI 0.50-1.08; P = 0.15). Secondary analysis showed that 75 (59%) of 128 patients achieved individual targets (irrespective of intervention) and sustained less morbidity (relative risk 3.41, 95% CI 2.19-5.31; P < 0.001). CONCLUSIONS: In high-risk patients undergoing cardiac surgery, individualized GDT therapy did not yield better outcomes, however, the achievement of preoperative individual targets may be associated with less morbidity. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT03103633. Registered on 1 April 2017.
Authors: Mathias Lühr Hansen; Simon Hyttel-Sørensen; Janus Christian Jakobsen; Christian Gluud; Elisabeth M W Kooi; Jonathan Mintzer; Willem P de Boode; Monica Fumagalli; Ana Alarcon; Thomas Alderliesten; Gorm Greisen Journal: Pediatr Res Date: 2022-02-22 Impact factor: 3.756
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