Prospective, randomized trial comparing fluids and dobutamine optimization of oxygen delivery in high-risk surgical patients [ISRCTN42445141]

Suzana M Lobo, Francisco R Lobo, Carlos A Polachini, Daniela S Patini, Adriana E Yamamoto, Neymar E de Oliveira, Patricia Serrano, Helder S Sanches, Marco A Spegiorin, Marcio M Queiroz, Antonio C Christiano Jr, Elisangela F Savieiro, Paula A Alvarez, Silvia P Teixeira, Geni S Cunrath, Suzana M Lobo, Francisco R Lobo, Carlos A Polachini, Daniela S Patini, Adriana E Yamamoto, Neymar E de Oliveira, Patricia Serrano, Helder S Sanches, Marco A Spegiorin, Marcio M Queiroz, Antonio C Christiano Jr, Elisangela F Savieiro, Paula A Alvarez, Silvia P Teixeira, Geni S Cunrath

Abstract

Introduction: Preventing perioperative tissue oxygen debt contributes to a better postoperative recovery. Whether the beneficial effects of fluids and inotropes during optimization of the oxygen delivery index (DO2I) in high-risk patients submitted to major surgeries are due to fluids, to inotropes, or to the combination of the two is not known. We aimed to investigate the effect of DO2I optimization with fluids or with fluids and dobutamine on the 60-day hospital mortality and incidence of complications.

Methods: A randomized and controlled trial was performed in 50 high-risk patients (elderly with coexistent pathologies) undergoing major elective surgery. Therapy consisted of pulmonary artery catheter-guided hemodynamic optimization during the operation and 24 hours postoperatively using either fluids alone (n = 25) or fluids and dobutamine (n = 25), aiming to achieve supranormal values (DO2I > 600 ml/minute/m2).

Results: The cardiovascular depression was an important component in the perioperative period in this group of patients. Cardiovascular complications in the postoperative period occurred significantly more frequently in the volume group (13/25, 52%) than in the dobutamine group (4/25, 16%) (relative risk, 3.25; 95% confidence interval, 1.22-8.60; P < 0.05). The 60-day mortality rates were 28% in the volume group and 8% in the dobutamine group (relative risk, 3.00; 95% confidence interval, 0.67-13.46; not significant).

Conclusion: In patients with high risk of perioperative death, pulmonary artery catheter-guided hemodynamic optimization using dobutamine determines better outcomes, whereas fluids alone increase the incidence of postoperative complications.

Figures

Figure 1
Figure 1
Treatment algorithm. MAP, mean arterial pressure; PAOP, pulmonary artery occlusion pressure; Ht, hematocrit; SaO2, arterial oxygen saturation; DO2I, oxygen delivery index; RBC, red blood cells; CI, cardiac index.
Figure 2
Figure 2
Oxygen delivery index during surgery and postoperatively. Oxygen delivery index (DO2I) during surgery and postoperatively for the volume group (●) and the dobutamine group (■). *P < 0.05 versus volume group, #P < 0.05 versus baseline. Results presented as the mean and standard error or the mean. 0, preoperative; 1, 30 min intraoperatively; 2, 2 hours intraoperatively; 3, 4 hours intraoperatively; 4, 6 hours intraoperatively; 5, 8 hours intraoperatively; 6, 0 hours postoperatively; 7, 4 hours postoperatively; 8, 8 hours postoperatively; 10, 12 hours postoperatively; 11, 16 hours postoperatively; 12, 24 hours postoperatively.

References

    1. Cullinane M, Gray AJ, Hargraves CM, Lansdown M, Martin IC, Schubert M. The 2003 Report of the National Confidential Enquiry into Peri-Operative Deaths. London: NCEPOD; 2003.
    1. Ayala A, Perrin MM, Chaudry IH. Defective macrophage antigen presentation following haemorrhage is associated with the loss of MHC class II (Ia) antigens. Immunology. 1990;70:33–39.
    1. Stephan RN, Kupper TS, Geha AS, Baue AE, Chaudry IH. Hemorrhage without tissue trauma produces immunosuppression and enhances susceptibility to sepsis. Arch Surg. 1987;122:62–68.
    1. Daly JM, Reynolds J, Sigal RK, Shou J, Liberman MD. Effect of dietary protein and amino acids on immune function. Crit Care Med. 1990;18(2 Suppl l):S86–S93.
    1. Shoemaker WC, Appel PL, Kram HB. Tissue oxygen debt as a determinant of lethal and nonlethal postoperative organ failure. Crit Care Med. 1988;16:1117–1120.
    1. Shoemaker WC, Appel PL, Kram HB, Waxman K, Lee TS. Prospective trial of supranormal values of survivors as therapeutic goals in high-risk surgical patients. Chest. 1988;94:1176–1186.
    1. Boyd O, Grounds M, Bennett D. A randomized clinical trial of the effect of deliberate perioperative increase of oxygen delivery on mortality in high-risk surgical patients. JAMA. 1993;270:2699–2708. doi: 10.1001/jama.270.22.2699.
    1. Wilson J, Woods I, Fawcett J, Whall R, Dibb W, Morris C, MacManus E. Reducing the risk of major elective surgery: Randomised controlled trial of preoperative optimisation of oxygen delivery. BMJ. 1999;318:1099–1103.
    1. Takala J, Meier-Hellmann A, Eddleston J, Hustaert P, Sramek U. Effect of dopexamine on outcome after major abdominal surgery: a prospective, randomized, controlled multicenter study. European Multicenter Study Group on Dopexamine in Major Abdominal Surgery. Crit Care Med. 2000;28:3417–3423. doi: 10.1097/00003246-200010000-00007.
    1. Lobo SM, Salgado PF, Castillo VG, Borim AA, Polachini CA, Palchetti JC, Brienzi SL, de Oliveira GG. Effects of maximizing oxygen delivery on morbidity and mortality in high-risk surgical patients. Crit Care Med. 2000;28:3396–3404. doi: 10.1097/00003246-200010000-00003.
    1. Kern JW, Shoemaker WC. Meta-analysis of hemodynamic optimization in high-risk patients. Crit Care Med. 2002;30:1686–1692. doi: 10.1097/00003246-200208000-00002.
    1. Rosenthal MH. Intraoperative fluid management – what and how much? Chest. 1999;115(5 Suppl):106S–112S. doi: 10.1378/chest.115.suppl_2.106S.
    1. Toller WG, Metzler H. Acute perioperative heart failure. Curr Opin Anaesthesiol. 2005;18:129–135. doi: 10.1097/01.aco.0000162830.59023.50.
    1. Mythen MG, Webb AR. Perioperative plasma volume expansion reduces the incidence of gut mucosal hypoperfusion during cardiac surgery. Arch Surg. 1995;130:423–429.
    1. Gan TJ, Soppitt A, Maroof M, el-Moalem H, Robertson KM, Moretti E, Dwane P, Glass PS. Goal-directed intraoperative fluid administration reduces length of hospital stay after major surgery. Anesthesiology. 2002;97:820–826. doi: 10.1097/00000542-200210000-00012.
    1. Venn R, Steele A, Richardson P, Poloniecki J, Grounds M, Newman P. Randomized controlled trial to investigate influence of the fluid challenge on duration of hospital stay and perioperative morbidity in patients with hip fractures. Br J Anaesth. 2002;88:65–71. doi: 10.1093/bja/88.1.65.
    1. Sinclair S, James S, Singer M. Intraoperative intravascular volume optimisation and length of hospital stay after repair of proximal femoral fracture: randomised controlled trial. BMJ. 1997;315:909–912.
    1. American Heart Association Guidelines for perioperative cardiovascular evaluation for noncardiac surgery. Circulation. 1996;93:1278–1317.
    1. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. The APACHE II – a severity of disease classification system. Crit Care Med. 1981;9:591–597.
    1. Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM. CDC definitions for nosocomial infections, 1988. Am J Infect Control. 1988;16:128–140. doi: 10.1016/0196-6553(88)90053-3.
    1. American College of Chest Physicians/Society of Critical Care Medicine Consensus Conference: definitions for sepsis and guidelines of innovative therapies in sepsis. Crit Care Med. 1992;20:864–874.
    1. Ruokonen E, Parviainen I, Uusaro A. Treatment of impaired perfusion in septic shock. Ann Med. 2002;34:590–597. doi: 10.1080/078538902321117814.
    1. Pearse R, Dawson D, Fawcett J, Rhodes A, Grounds RM, Bennett ED. Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445] Crit Care. 2005;9:687–693. doi: 10.1186/cc3887.
    1. Szabo C, Hasko G, Zingarelli B, Nemeth ZH, Salzman AL, Kvetan V, Pastores SM, Vizi ES. Isoproterenol regulates tumour necrosis factor, interleukin-10, interleukin-6 and nitric oxide production and protects against the development of vascular hyporeactivity in endotoxaemia. Immunology. 1997;90:95–100. doi: 10.1046/j.1365-2567.1997.00137.x.
    1. De Backer D, Creteur J, Dubois MJ, Sakr Y, Koch M, Verdant C, Vincent JL. The effects of dobutamine on microcirculatory alterations in patients with septic shock are independent of its systemic effects. Crit Care Med. 2006;34:403–408. doi: 10.1097/01.CCM.0000198107.61493.5A.
    1. Duranteau J, Sitbon P, Teboul JL, Vicaut E, Anguel N, Richard C, Samii K. Effects of epinephrine, norepinephrine, or the combination of norepinephrine and dobutamine on gastric mucosa in septic shock. Crit Care Med. 1999;27:893–900. doi: 10.1097/00003246-199905000-00021.
    1. Swisher SG, Holmes EC, Hunt KK, Gornbein JA, Zinner MJ, McFadden DW. Perioperative blood transfusions and decreased long-term survival in esophageal cancer. J Thorac Cardiovasc Surg. 1996;112:341–348. doi: 10.1016/S0022-5223(96)70260-X.
    1. Malone DL, Dunne J, Tracy JK, Putnam AT, Scalea TM, Napolitano LM. Blood transfusion, independent of shock severity, is associated with worse outcome in trauma. J Trauma. 2003;54:898–905.
    1. Lobo DN, Bostock KA, Neal KR, Perkins AC, Rowlands BJ, Allison SP. Effect of salt and water balance on recovery of gastrointestinal function after elective colonic resection: A randomised controlled trial. Lancet. 2002;359:1812–1818. doi: 10.1016/S0140-6736(02)08711-1.
    1. Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, et al. Danish Study Group on Perioperative Fluid Therapy: effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003;238:641–648. doi: 10.1097/01.sla.0000094387.50865.23.
    1. Nisanevich V, Felsenstein I, Almogy G, Weissman C, Einav S, Matot I. Effect of intraoperative fluid management on outcome after intraabdominal surgery. Anesthesiology. 2005;103:25–32. doi: 10.1097/00000542-200507000-00008.
    1. Poldermans D, Boersma E, Bax JJ, Thomson IR, van de Ven LL, Blankensteijn JD, Baars HF, Yo TI, Trocino G, Vigna C, et al. The effect of bisoprolol on perioperative mortality and myocardial infarction in high-risk patients undergoing vascular surgery. Dutch Echocardiographic Cardiac Risk Evaluation Applying Stress Echocardiography Study Group. N Engl J Med. 1999;341:1789–1794. doi: 10.1056/NEJM199912093412402.
    1. Oh YJ, Lee JH, Kim JY, Song JW, Hong YW, Kwak YL. The haemodynamic effects of propranolol and atenolol medication on dobutamine infusion in patients with coronary artery obstructive disease. J Int Med Res. 2005;33:329–336.
    1. Waagstein F, Malek I, Hjalmarson AC. The use of dobutamine in myocardial infarction for reversal of the cardiodepressive effect of metoprolol. Br J Clin Pharmacol. 1978;5:515–521.
    1. De Backer D. Optimal management of the high risk surgical patient: beta stimulation or beta blockade? Crit Care. 2005;9:645–646. doi: 10.1186/cc3930.

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