The existing standard SOFA characteristics include a standard value for the use of dopamine, dobutamine, epinephrine or norepinephrine. It is now common in clinical practice to add vasopressin ADH and its analogues to the management of septic shock as part of the standard of sepsis care to reduce norepinephrine dose required to achieve a target MAP [ 23 ].
Additional vasopressor agents such as terlipressin and angiotensin II may be used in some centres and may have a norepinephrine sparing effect although formal evidence of their dose equivalence with norepinephrine is lacking; therefore, agents should be considered when calculating an equivalent norepinephrine dose. The conversion table below Table 4 is derived from a number of sources [ 24 ] and allows study teams to include the dose of vasopressin and other agents as part of the SOFA calculation in order to avoid falsely low CVS SOFA values in patients receiving combination therapy.
The use of defined blood pressure targets can, to some degree confound the calculation of CVS SOFA based on vasopressor dose alone; however, in clinical trials with defined haemodynamic targets, consistency across the study groups should allow robust comparison of the CVS SOFA scores based on the guidance offered below as between group differences in vasopressor requirement will be reflected in the SOFA calculation.
Study teams should define the duration of a period without vasopressor administration that should elapse before an episode of vasopressor therapy is considered complete.
Receipt of a vasopressor at any point within the h window of assessment of the SOFA score should merit a score representing that requirement. Vasopressin may be used as a second agent to reduce total noradrenaline dose. The peak level of cardiovascular support for a given h period should be used to calculate the daily cardiovascular SOFA score. The surviving sepsis guidelines call for the use of renal replacement therapy RRT in the management of symptomatic renal failure or fluid balance in patients with haemodynamic instability [ 23 ].
The SOFA score is based on the clinical indices of creatinine or urine output, both of which will be affected by the presence of renal replacement therapy. Given the wide variety of application of renal replacement therapy between ICUs, this could introduce substantial variability in the SOFA score for patients included in clinical trials.
One approach to this would be to consider applying a renal sub-score of four in patients undergoing renal replacement therapy. The period of time that should elapse after cessation of RRT before a patient is considered to have been liberated from renal support is not defined by the literature.
Study teams should develop a formal strategy for SOFA score calculation in patients undergoing renal replacement therapy if using the SOFA score as a key outcome. The haematology component of the SOFA score is calculated using the measured platelet concentration. The administration of platelet transfusion is not recorded during scoring but may have a significant impact on the measured platelet concentrations and therefore the coagulation component of the SOFA score.
Standard guidance from the surviving sepsis council exists for the management of platelet therapy in patients with sepsis [ 23 ]. The lowest platelet value for the preceding 24 h should be determined before transfusion if given , and if platelets are given regularly, the lowest pre-transfusion value should be used to calculate each daily score.
Any score that is dependent upon the assessment of clinical criteria and laboratory variables may be subject to variation in that assessment. Reasons for this include different laboratory assays, changes in personnel undertaking examinations and confounders not measured within the score.
The calculation of the SOFA score is at risk of each of these potential pitfalls. In their study, Tallgren et al. The pattern of these data was consistent with an earlier single-centre study of 30 patients, assessed by 20 clinicians [ 26 ].
The Finnish study demonstrated that a short training session led to substantial improvements in scoring performance, a reduction in the degree of variation in the overall score and in the number of errors in the overall score greater than one or two points [ 17 ]. Studies including SOFA scoring as an inclusion criteria or outcome should consider a formal training package for recruiting centres to reduce inaccuracy and variability in different centres.
A number of modifications have been proposed to the SOFA score including assessments that require fewer laboratory measurements. A number of studies have shown that various components of the score can be removed or replaced by using for example, clinical assessment of jaundice rather than serum bilirubin or urine output instead of creatinine. The revised respiratory sub-score using peripheral oxygen saturations discussed above produced results consistent with the standard SOFA assessment [ 20 , 27 , 28 ].
Other approaches include the addition of a further factor such as the time since last infection which offers increased predictive ability in specific patient groups, for example in populations with haematological malignancy [ 29 , 30 ]. It has been proposed that the neurological component of the SOFA score could be replaced with an alternative measure such as the Richmond Agitation and Sedation Score RASS [ 31 ]; however, since the RASS is a marker of sedation and not neurological status, this approach has not been recommended as an approach by the original developers of the SOFA score [ 32 ].
In small studies in specific or centres or environments, modified SOFA scoring may offer an attractive solution to some of the challenges of standard SOFA. However, these tools have not been validated prospectively across multiple centres and therefore cannot be recommended as replacement for the traditional approach at this stage. In addition, some of these scores potentially increase the likelihood of inaccuracy due to a reduction in the number of laboratory assays that they employ and dependence on clinical assessment by individuals.
Defining the syndrome of sepsis has proven challenging since the initial consensus definitions were developed in the early s [ 34 ]. The definitions of sepsis and septic shock were based on expert consensus [ 35 , 36 , 37 , 38 ]. In , a novel approach saw a data-driven redefinition as:. By using a change in SOFA score, the authors recognised that whilst SOFA score can often be considered zero in previously healthy patients, the presence of chronic organ dysfunction precludes the use of an absolute value to define the presence of infection [ 3 ].
This transition from observing to defining a syndrome has significant relevance for clinicians and researchers in critical care. This approach confers the advantage that shorter periods of follow-up are required to determine efficacy, although this is valid only if a change in SOFA is a clinically relevant outcome or that is a true surrogate of a later important outcome.
This approach will have greater validity if, as with all composite outcomes, study teams also report the sub-scores that make up the SOFA as part of the trial data. Interestingly, the study did not calculate vasopressor dose equivalence in the intervention group including angiotensin II, a limitation that future studies of vasopressors should consider addressing. This approach confers the advantage that in the event of a patient death prior to the end of study, the mean SOFA score over the period remains comparable across all patients regardless of duration of survival and means that no patients are excluded from the end point analysis.
They demonstrated that using delta SOFA was significantly correlated with mortality with a low degree of heterogeneity. A fixed day SOFA as an endpoint was not reliably associated with mortality.
The authors note that many of the included studies were small median IQR 64 40— patients. The SOFA score was developed to describe the acute morbidity of patient populations with critical illness in different settings. The use of the tool for this purpose has been repeatedly validated and, over the years that followed its development, its role has extended to a range of new indications.
It is now a defining characteristic of the sepsis syndrome which means that interventions and treatments delivered to individual patients depend on precise and consistent assessment of the score. In addition, the acceptance by the EMA that in exploratory clinical trials in sepsis, a change in organ dysfunction scores is a valid endpoint [ 4 ], has led to the change in SOFA score being selected as a primary outcome in a number of recent and ongoing studies, alongside the reporting of mortality.
There is evidence from a range of observational study settings that even a modest change in SOFA score is associated with a persistent trend in mortality. In the context of randomised trials, de Grooth et al. They went on to recommend, based on the mean standard deviation of those studies, that patients would be required in each treatment arm of a study to detect a one point difference in delta SOFA. If detected, they inferred that this would in turn be associated with a mortality odds ratio of 2.
The authors concluded that aiming to detect a greater difference than this would be unrealistic and therefore this should represent a minimum sample size in studies using delta SOFA as a primary endpoint. It is important to recognise therefore that the ability to detect single-integer changes in the overall SOFA score with low inter-individual and inter-centre variability becomes essential in the conduct of randomised trials employing this outcome.
Like all scores that assess the clinical course of critically ill patients based at least in part upon levels of organ support and assessments undertaken at single time points, SOFA scores can, as we describe, be confounded by clinical interventions. As a consequence, the development of standard protocols for the assessment and management of patients in clinical trials is essential in order to minimise inter-patient variability and ensure that results of surrogate assessments like SOFA are robust.
In this review, we propose solutions and pragmatic approaches to calculating the SOFA score which have the potential to improve the reliability of assessments and mitigate some of the sources of heterogeneity that could prove important in new applications of the score. Training of study teams in the measurement of the SOFA score and application of study guidance is an important part of this process and should be considered in all studies including the SOFA score as an inclusion criteria or end point.
The evidence base available to determine the guidance presented here is limited, and study authors should consider this before defining the approaches they will take to assessment of the SOFA score. Balancing the requirement for robust and consistent calculation with the introduction of unvalidated approaches and the inadvertent development of a new scoring system is an important challenge for clinical triallists to address. Developing a new definition and assessing new clinical criteria for septic shock: for the third international consensus definitions for sepsis and septic shock sepsis The third international consensus definitions for sepsis and septic shock sepsis Guideline on clinical investigation of medicinal products for the treatment of sepsis.
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Comparison of multiple organ dysfunction scores in the prediction of hospital mortality in the critically ill. PubMed Article Google Scholar. Utility of SOFA score, management and outcomes of sepsis in Southeast Asia: a multinational multicenter prospective observational study. J Intensive Care. Handling of missing outcome data in traumatic brain injury research: a systematic review. J Neurotrauma. When and how should multiple imputation be used for handling missing data in randomised clinical trials — a practical guide with flowcharts.
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A modified sequential organ failure assessment score for critical care triage. Dis Med Publ Health Prep. Article Google Scholar. Scientifica Cairo. Sequential Organ Failure Assessment score modified for recent infection in patients with hematologic malignant tumors and severe sepsis. Am J Crit Care. The prognostic value of a trend in modified SOFA score for patients with hematological malignancies in the intensive care unit.
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Crit Care. Eur J Emerg Med. Usefulness of measuring changes in SOFA score for the prediction of day mortality in patients with sepsis-associated disseminated intravascular coagulation. Clin Appl Thromb Hemost. Mastuda J. The assessment of sofa score predicts mortality and neurological outcome in post-cardiac arrest syndrome patients.
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