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May 4, 2016

ESA 2016

Goal directed hemodynamic therapy decresases postoperative complications. Results from a multicenter randomized controlled trial

;

Casans Francés R.;

Martínez Hurtado E.;

Álvarez Baena L.;

Lucena E.;

Calvo Vecino J.M.;

EAR GROUP

Abstract

Abstract

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Keywords

Abstract

Background and Goal of Study: Goal directed hemodynamic therapy (GDHT) has been associated with a reduction complication rates after mayor surgery. The aim of the study was to evaluate the postoperative complications in patients undergoing mayor elective surgery using GDHT guided by measures stroke volume (SV), mean arterial pressure (MAP) and cardiac index (CI) by esophageal Doppler monitoring (EDM) through administering fluids, inotropes and vasopressors. Materials and methods: Prospective, multicenter, randomized, unfunded controlled trial (ISRCTN93543537). After ethical committee approval and written informed consent were obtained, we enrolled adult ASA IIII patients scheduled for elective major surgery (gastrointestinal, urological, gynaecological and orthopaedic). Randomization and allocation to trial group were carried out by a central computer system. In the control group (CG), intraoperative fluid therapy was administered according to conventional practice. In the GDHT group (GG), the intraoperative goals were to maintain and optimal SV, a MAP >70mmHg, and a CI >= 2.5 L/min/m2. Complications and Outcome data were recorded up to 180 days postoperatively. Primary outcome was postoperative complications. The qualitative variables are described frequency distribution and quantitative in mean and standard deviation (SD) or median and interquartile range (IQR), if asymmetry. Study groups were compared according to the recommendations of the CONSORT standards. The study was completed by low recruitment. Results and discussion: 450 patients were randomized to the GG (n=224 patients) or to the CG (n=226 patients). 428 were analyzed. The number of complications was significantly lower in the GG (56 complications vs. 198 complications, p< 0.01); as the number of patients with complications 15% vs 27.6% p=0.001, OR: 0.46 CI 95% 0.290.75 (Relative Risk Reduction 56.4%), certain specific complications (Figure 1) and length of stay: Median IQR 5 (410) vs 7 (712) p 0.002. Conclusion(s): GDHT using SV, CI trending and MAP as the key parameters leads to a decrease in postoperative complications in patients undergoing major surgery.

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All rights reserved.