David Pestaña1, Elena Espinosa, Arieh Eden, Diana Nájera, Luis Collar, César Aldecoa, Eva Higuera, Soledad Escribano, Dmitri Bystritski, Javier Pascual, Pilar Fernández-Garijo, Blanca de Prada, Alfonso Muriel, Reuven Pizov. 1. From the *Department of Anesthesiology and Critical Care, Hospital Universitario La Paz, Madrid, Spain; †Department of Anesthesiology and Critical Care, Hospital Universitario Nuestra Señora de Candelaria, Tenerife, Spain; ‡Departments of Anesthesiology, Critical Care, and Pain Medicine, Carmel Lady Davis Medical Center and the Bruce Rappaport Faculty of Medicine, The Technion, Haifa, Israel; §Department of Anesthesiology and Critical Care, Hospital General, Ciudad Real, Spain; ‖Department of Anesthesiology and Critical Care, Hospital Universitario Río Hortega, Valladolid, Spain; ¶Department of Anesthesiology and Critical Care, Complejo Asistencial Universitario, León, Spain; and #Clinical Biostatistics Unit, Hospital Universitario Ramón y Cajal, IRYCIS, CIBERESP, Madrid, Spain. David Pestaña, PhD, is currently affiliated with Department of Anesthesiology and Critical Care, Hospital Universitario Ramón y Cajal, IRICYS, Madrid, Spain.
Abstract
BACKGROUND: In this study, our objective was to determine whether a perioperative hemodynamic protocol based on noninvasive cardiac output monitoring decreases the incidence of postoperative complications and hospital length of stay in major abdominal surgery patients requiring intensive care unit admission. Secondary objectives were the time to peristalsis recovery and the incidence of wound infection, anastomotic leaks, and mortality. METHODS: A randomized clinical trial was conducted in 6 tertiary hospitals. One hundred forty-two adult patients scheduled for open colorectal surgery, gastrectomy, or small bowel resection were enrolled. A hemodynamic protocol including fluid administration and vasoactive drugs based on arterial blood pressure, cardiac index, and stroke volume response was compared with standard practice. Patients were followed until hospital discharge (determined by a surgeon blinded to the study) or death. In contrast to previous studies, we designed a pragmatic trial (as opposed to explanatory trials) to mimic real practice and obtain maximal external validity for the study. RESULTS: Fluid administration was similar except for the number of colloid boluses (2.4 ± 1.8 [treated] vs 1.3 ± 1.4 [control]; P < 0.001) and packed red blood cell units (0.6 ± 1.3 [treated] vs 0.2 ± 0.6 [control]; P = 0.019). Dobutamine was used in 25% (intraoperatively) and 19.4% (postoperatively) of the treated patients versus 1.4% and 0% in the control group (P < 0.001). We have observed a reduction in reoperations in the treated group (5.6% vs 15.7%; P = 0.049). However, no significant differences were observed in overall complications (40% vs 41%; relative risk 0.99 [0.67-1.44]; P = 0.397), length of stay (11.5 [8-15] vs 10.5 [8-16]; P = 0.874), time to first flatus (62 hours [40-76] vs 72 hours [48-96]; P = 0.180), wound infection (7 vs 14; P = 0.085), anastomotic leaks (2 vs 5; P = 0.23), or mortality (4.2% vs 5.7%; P = 0.67). CONCLUSIONS: The results of our pragmatic study indicate that a perioperative hemodynamic protocol guided by a noninvasive cardiac output monitor was not associated with a decrease in the incidence of overall complications or length of stay in major abdominal surgery.
RCT Entities:
BACKGROUND: In this study, our objective was to determine whether a perioperative hemodynamic protocol based on noninvasive cardiac output monitoring decreases the incidence of postoperative complications and hospital length of stay in major abdominal surgery patients requiring intensive care unit admission. Secondary objectives were the time to peristalsis recovery and the incidence of wound infection, anastomotic leaks, and mortality. METHODS: A randomized clinical trial was conducted in 6 tertiary hospitals. One hundred forty-two adult patients scheduled for open colorectal surgery, gastrectomy, or small bowel resection were enrolled. A hemodynamic protocol including fluid administration and vasoactive drugs based on arterial blood pressure, cardiac index, and stroke volume response was compared with standard practice. Patients were followed until hospital discharge (determined by a surgeon blinded to the study) or death. In contrast to previous studies, we designed a pragmatic trial (as opposed to explanatory trials) to mimic real practice and obtain maximal external validity for the study. RESULTS: Fluid administration was similar except for the number of colloid boluses (2.4 ± 1.8 [treated] vs 1.3 ± 1.4 [control]; P < 0.001) and packed red blood cell units (0.6 ± 1.3 [treated] vs 0.2 ± 0.6 [control]; P = 0.019). Dobutamine was used in 25% (intraoperatively) and 19.4% (postoperatively) of the treated patients versus 1.4% and 0% in the control group (P < 0.001). We have observed a reduction in reoperations in the treated group (5.6% vs 15.7%; P = 0.049). However, no significant differences were observed in overall complications (40% vs 41%; relative risk 0.99 [0.67-1.44]; P = 0.397), length of stay (11.5 [8-15] vs 10.5 [8-16]; P = 0.874), time to first flatus (62 hours [40-76] vs 72 hours [48-96]; P = 0.180), wound infection (7 vs 14; P = 0.085), anastomotic leaks (2 vs 5; P = 0.23), or mortality (4.2% vs 5.7%; P = 0.67). CONCLUSIONS: The results of our pragmatic study indicate that a perioperative hemodynamic protocol guided by a noninvasive cardiac output monitor was not associated with a decrease in the incidence of overall complications or length of stay in major abdominal surgery.
Authors: Asi Ukere; Sebastian Meisner; Gillis Greiwe; Benjamin Opitz; Daniel Benten; Björn Nashan; Lutz Fischer; Constantin J C Trepte; Daniel A Reuter; Sebastian A Haas; Christoph R Behem Journal: J Clin Monit Comput Date: 2016-12-23 Impact factor: 2.502
Authors: Martin Ernst Blohm; Jana Hartwich; Denise Obrecht; Jan Felix Kersten; Dominique Singer Journal: J Clin Monit Comput Date: 2016-04-12 Impact factor: 2.502