Targeting skeletal muscle tissue oxygenation (StO₂) in adults with severe sepsis and septic shock: a randomised controlled trial (OTO-StS Study)

Abstract

ObjectiveEvaluation of the ratio of oxyhaemoglobin to total haemoglobin in skeletal muscle (StO2) using near-infrared spectroscopy may aid in the monitoring of patients with sepsis. This study assessed the benefits and risks of targeting StO2 in adults with severe sepsis or septic shock.DesignA European randomised controlled trial was performed on two parallel groups.SettingFive intensive care units (ICU) in France, Greece, Spain and Germany were used for the study.ParticipantsA total of 103 adults with severe sepsis or septic shock on ICU admission were randomised (54 subjects in the experimental arm and 49 subjects in the control arm).InterventionsHaemodynamic management using an algorithm that was adapted from the 2004 Surviving Sepsis Campaign guidelines with (experimental arm) or without (control arm) targeting an StO2 value greater than 80% at a minimum of two different sites.OutcomesThe primary outcome was a composite: 7-day all-cause mortality or worsening of organ function, defined as a positive difference in Sepsis-related Organ Failure Assessment (SOFA) score between day 7 and randomisation (ie, delta SOFA >0). Secondary endpoints: 30-day mortality, duration of mechanical ventilation and vasopressor therapy up to 30 days from randomisation.ResultsThe study ended prematurely due to lack of funding after enrolment of 103/190 patients. Eighteen patients (33.3%) in the experimental arm and 14 (28.6%, P=0.67) in the control arm died or exhibited delta SOFA >0 on day 7. The mean number of days on mechanical ventilation was 12.2±10.6 in the experimental group and 7.6±7.9 in the control group (P=0.03). Thirty-one (57%) patients in the experimental arm and 14 (29%) patients in the control arm received red cells by day 7 (P=0.01).ConclusionDespite the limitation related to premature termination, this study provides no data to support the routine implementation of resuscitation protocols incorporating StO2 >80% at two or more muscle sites as a target. StO2-guided therapy may be associated with prolonged use of mechanical ventilation and an increased number of red blood cell transfusions.Trial registration number NCT00167596; Results.

Impact of increased mean arterial pressure on skin microcirculatory oxygenation in vasopressor-requiring septic patients: an interventional study

“…Indeed, in this study higher severity of organ failure measured by SOFA score was associated with lower skin oxygen saturation values. Similar to our study, low thenar muscle oxygen saturation measured by near-infrared spectroscopy (NIRS) was found to be present in 60% of patients with sepsis [21], but only dynamic changes in tissue oxygenation after vascular occlusion test have been shown to be related to organ failure [22]. In our study, we targeted measurement only to the most hypoxic areas of the skin, and our data support a more direct link between hypoxia in microcirculatory beds and development of multiple organ failure.…”

Near-Infrared Spectroscopy in Adult Circulatory Shock: A Systematic Review

“…Overall, randomized controlled trials on NIRS monitoring in critically ill adult patients are scarce. Only 2 randomized controlled trials of NIRS-guided treatment were identified by our searches: a small pilot study 37 and the subsequent larger trial 38 by the same study group. However, these studies could not be included in the review, as they also included patients with severe sepsis.…”

Assessment of the peripheral microcirculation in patients with and without shock: a pilot study on different methods

“…However, the utility of NIRS in the management of critically ill patients is still a matter of debate. A recent randomized trial study of StO 2 -guided resuscitation with sepsis or septic shock patients at ICU admission found that the inclusion of StO 2 > 80% as a target in the algorithm for early goal-directed therapy did not improve clinical outcomes [42]. Moreover, this experimental algorithm of resuscitation was associated with more time on mechanical ventilation, more blood transfusion and more use of inotropes [42].…”

“…A recent randomized trial study of StO 2 -guided resuscitation with sepsis or septic shock patients at ICU admission found that the inclusion of StO 2 > 80% as a target in the algorithm for early goal-directed therapy did not improve clinical outcomes [42]. Moreover, this experimental algorithm of resuscitation was associated with more time on mechanical ventilation, more blood transfusion and more use of inotropes [42]. However, another randomized controlled pilot study was performed comparing a peripheral perfusion-guided early fluid resuscitation with a classical strategy based on MAP, CVP and CI in septic shock patients admitted to the ICU [43].…”