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.
Published ahead of print July 9, 2014.
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.
Published ahead of print July 9, 2014.
Accepted for publication March 27, 2014.
Funding: The monitors and the electrode stickers required for the study were provided by Cheetah Medical. None of the investigators received any economic wages or compensation for the study or has any personal relationship or interest relevant to the subject matter of the manuscript.
The authors declare no conflicts of interest.
Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website.
Reprints will not be available from the authors.
Address correspondence to David Pestaña, PhD, Servicio de Anestesia-Reanimación, Hospital Universitario Ramón y Cajal, Ctra. de Colmenar Viejo km 9, 28034 Madrid, Spain. Address e-mail to firstname.lastname@example.org; email@example.com