Vasodilatory therapy with nitroglyceryn in patients with septic shock

Abstract

Rationale: Recent clinical studies have shown a relationship between abnormalities in peripheral perfusion and unfavorable outcome in patients with septic shock. Nitroglycerin may be effective to restore alterations in microcirculatory blood flow. This study is aimed to investigate whether nitroglycerin administration could correct the abnormalities on peripheral circulation of resuscitated septic shock patients and improve the outcomes.Objective: Seventy adult septic shock patients with sustained clinical parameters of abnormal peripheral perfusion despite adequate resuscitation (central venous pressure, mean arterial blood pressure and central venous oxygen saturation) will be randomized to receive intravenous nitroglycerin (intervention group) or placebo (control group). We hypothesize that stepwise doses of intravenous infusion of nitroglycerin, administered within the first 48 hours after stabilization of macrohemodynamic parameters, can reduce the incidence of organ failure quantified by the SOFA score and reverse the abnormalities in microcirculation. The microcirculation will be adressed by direct visualization with the Sidestream Dark-field (SDF) technique. Study design: Prospective phase II clinical trial, multicenter, exploratory, randomized, placebo-controlled, double-blinded, with concealed allocation and intention-to-treat analysis. In Brazil, this study will be performed at the Intensive Care Unit of the Hospital Israelita Albert Einstein. (AU)