Randomized study on the evaluation of goal directed therapy in high risk cardiac surgery

• Grant number: 11/11987-5
• Support Opportunities: Regular Research Grants
• Duration: October 01, 2011 - September 30, 2013
• Field of knowledge: Health Sciences - Medicine
• Principal Investigator: Ludhmila Abrahão Hajjar
• Grantee: Ludhmila Abrahão Hajjar
• Host Institution: Instituto do Coração Professor Euryclides de Jesus Zerbini (INCOR). Hospital das Clínicas da Faculdade de Medicina da USP (HCFMUSP). Secretaria da Saúde (São Paulo - Estado). São Paulo , SP, Brazil
• Associated researchers: Eduardo Atsushi Osawa ; Filomena Regina Barbosa Gomes Galas ; José Otávio Costa Auler Junior ; Juliano Pinheiro de Almeida ; Noedir Antônio Groppo Stolf

Abstract

Patients submitted to high risk cardiac surgery have elevated morbidity and mortality. Hemodynamic therapy constitutes a challenge that starts intraoperatively and extends to the first hours of postoperative period. Goal directed therapy (GDT) represents a strategy evaluated in many scenarios whereby a reduction in hospital stay and morbi-mortality was observed, but few studies are available in the context of cardiac surgery. Objectives: To evaluate the outcomes of a GDT protocol applied to patients submitted to high risk cardiac surgery regarding the number of days of ICU stay. Secondary objectives are comparison of organ dysfunction score (SOFA), incidence of cardiogenic shock, myocardial ischemia, acute renal failure, acute respiratory distress syndrome, infection, evaluation of tissue hypoperfusion markers, comparison of pressor/inotrope-free days, mechanical ventilation-free days, dialysis free-days and analysis of cost. Methods: Prospective randomized study which will include 126 patients who are candidates to CABG or valve surgery, with an addictive EuroSCORE of 6 points or higher. The sample size was calculated based on an alpha error of 0,05 and a 80% power to detect a reduction in one day of ICU stay in the GDT group. GDT group will be monitored through central venous catheter, invasive arterial pressure and LiDCO Rapid monitor. The protocol will start intraoperatively and be maintained within the first 8 hours of postoperative period. The main goal will be achievement of a cardiac index higher than 3L/min/m2 through Lactated Ringer's 500ml aliquots, dobutamine infusion with increasing dose of 5mcg/kg/min every 15 minutes and hemotransfusion to reach hematocrit higher than 28%. (AU)

Scientific publications

(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)

OSAWA, EDUARDO A.; RHODES, ANDREW; LANDONI, GIOVANNI; GALAS, FILOMENA R. B. G.; FUKUSHIMA, JULIA T.; PARK, CLARICE H. L.; ALMEIDA, JULIANO P.; NAKAMURA, ROSANA E.; STRABELLI, TANIA M. V.; PILEGGI, BRUNNA; et al. Effect of Perioperative Goal-Directed Hemodynamic Resuscitation Therapy on Outcomes Following Cardiac Surgery: A Randomized Clinical Trial and Systematic Review. Critical Care Medicine, v. 44, n. 4, p. 724-733, APR 2016. (11/11987-5)