Abstract
Objective: To evaluate the outcome of patients with septic shock after the institution of a patient tailored therapy protocol in our Intensive Care Unit (ICU).Methods: Single-center retrospective observational study including 100 consecutive septic patients (≥ 16 years) requiring norepinephrine infusion, admitted to our ICU between 2018 and 2019 after the institution of a patient-tailored therapy protocol, compared with a historical control group of 100 patients admitted between 2010 and 2013 (historical controls). The patient-tailored therapy protocol included the use of IgM-enriched immunoglobulins for patients with low plasma IgM levels, blood purification strategies for patients with high plasma levels of cytokines or endotoxin, albumin correction and modulation of vasoactive agents. Clinical and therapeutic parameters were noted at the time of initiation of norepinephrine infusion and for the 1st 24 h. The primary outcome was ICU mortality.Results: ICU-mortality was lower in the patient-tailored therapy cohort as compared to historical controls (32 vs. 57%, p < 0.001). Patient-tailored therapy was associated with a lower risk of ICU-mortality even after adjusting for the main clinical severity indices (adjusted odds ratio 0.331 [95% confidence interval 0.166–0.658], p = 0.002). After propensity score matching, 48 patients in historical control group and 48 patients in the patient-tailored therapy cohort with similar general characteristics were selected. ICU-mortality was lower in the patient-tailored therapy matched subgroup as compared to historical controls (40 vs. 60%, p = 0.037).Conclusions: An individualized therapeutic approach in septic patients may be associated with a survival benefit. However, the use of an historical control group of patients admitted between 2010 and 2013 may introduce substantial bias. Further adequately designed studies are needed to demonstrate the impact of patient-tailored therapy on outcome.
Highlights
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection (1)
Patients in the patient-tailored therapy group had higher SAPS II on ICUadmission but lower Sequential Organ Failure Assessment (SOFA) score at the time of initiation of norepinephrine and the number of those with pre-existing immunosuppression tended to be lower in this group as compared to historical controls
The main source of infection was respiratory in both groups, among historical controls we observed a higher prevalence of abdominal sepsis while the patient-tailored therapy group showed more cases of genito-urinary sepsis and bactaeremia
Summary
Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection (1). Septic patients are a heterogeneous population (2), because of the pathophysiological complexity underlying this syndrome, and because of the different basal characteristics of individual patient: for this reason, it is difficult to find a single therapy that may be effective for everyone (3, 4). The therapeutic strategy must be based on the underlying physiological reserve, pre-existing comorbidities and organ dysfunction severity (2), with a patient tailored therapy approach. A multicentre trial showed that a higher blood pressure target may be required in patients with a history of arterial hypertension (6), suggesting that an individualized approach may be preferable. Different immunomodulation treatments, including intravenous immunoglobulins or extracorporeal blood purification techniques, taken individually, did not show a clear positive correlation with outcome (5), but a more careful patient selection (based on immunoglobulin and cytokine levels) may be necessary to better show an impact on survival
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