THE SVO(2) STUDY - GENERAL DESIGN AND RESULTS OF THE FEASIBILITY PHASE OF A MULTICENTER, RANDOMIZED TRIAL OF 3 DIFFERENT HEMODYNAMIC APPROACHES AND 2 MONITORING TECHNIQUES IN THE TREATMENT OF CRITICALLY ILL PATIENTS

Although the attainment of normal hemodynamic values has always been a ssumed to be the therapeutic target for critically ill patients, recen t studies reported increased values in oxygen transport varia bles in survivors of high-risk surgery. It has been supposed that the higher v alues observed in survivors might indicate a physiological compensatio n for the increased metabolic requirements due to disease. We designed a randomized, multicentric trial to evaluate the effect of high value s of cardiac index(CI) and oxygen delivery (DO2) in critically ill pat ients. Patients enrolled in the study are randomized to three differen t hemodynamic targets:normal values of CI (2.5 < CI < 3.5 L min m, and mixed venous oxygen saturation (SvO2) > 70% or (Sata-Satv) < 20%. Two different monitoring systems are used to maintain the target: convent ional Swan-Ganz catheter with scheduled samples of mixed venous O2 sat uration, and optical catheter with continuous SvO2 evaluation. The aim of the study is to alnswer three questions regarding the hypothesis r eported above: (1) Are results in postoperative patients applicable to other pathological groups? (2) Does continuous monitoring of SvO2 pro vide advantages over conventional hemodynamic monitoring? (3) Is a nor mal SvO2 rather than a supranormal CI a good and predictable therapeut ic goal? We report herein the protocol of the study and the results of the pilot phase, which was conducted in 98 critically ill patients en rolled by 56 participating centers to evaluate the safety and feasibil ity of the porposed trial.