Clinical evaluation of an interoperable clinical decision-support system for the detection of systemic inflammatory response syndrome in critically ill children.

BACKGROUND: Systemic inflammatory response syndrome (SIRS) is defined as a non-specific inflammatory process in the absence of infection. SIRS increases susceptibility for organ dysfunction, and frequently affects the clinical outcome of affected patients. We evaluated a knowledge-based, interoperable clinical decision-support system (CDSS) for SIRS detection on a pediatric intensive care unit (PICU). METHODS: The CDSS developed retrieves routine data, previously transformed into an interoperable format, by using model-based queries and guideline- and knowledge-based rules. We evaluated the CDSS in a prospective diagnostic study from 08/2018-03/2019. 168 patients from a pediatric intensive care unit of a tertiary university hospital, aged 0 to 18 years, were assessed for SIRS by the CDSS and by physicians during clinical routine. Sensitivity and specificity (when compared to the reference standard) with 95% Wald confidence intervals (CI) were estimated on the level of patients and patient-days. RESULTS: Sensitivity and specificity was 91.7% (95% CI 85.5-95.4%) and 54.1% (95% CI 45.4-62.5%) on patient level, and 97.5% (95% CI 95.1-98.7%) and 91.5% (95% CI 89.3-93.3%) on the level of patient-days. Physicians' SIRS recognition during clinical routine was considerably less accurate (sensitivity of 62.0% (95% CI 56.8-66.9%)/specificity of 83.3% (95% CI 80.4-85.9%)) when measurd on the level of patient-days. Evaluation revealed valuable insights for the general design of the CDSS as well as specific rule modifications. Despite a lower than expected specificity, diagnostic accuracy was higher than the one in daily routine ratings, thus, demonstrating high potentials of using our CDSS to help to detect SIRS in clinical routine. CONCLUSIONS: We successfully evaluated an interoperable CDSS for SIRS detection in PICU. Our study demonstrated the general feasibility and potentials of the implemented algorithms but also some limitations. In the next step, the CDSS will be optimized to overcome these limitations and will be evaluated in a multi-center study. TRIAL REGISTRATION: NCT03661450 (ClinicalTrials.gov); registered September 7, 2018.

Systemic inflammatory response syndrome after pediatric congenital heart surgery: Incidence, risk factors, and clinical outcome.

BACKGROUND: Systemic inflammatory response syndrome (SIRS) is frequent after cardiac surgery, but data on its incidence and perioperative risk factors are scarce for children with congenital heart disease. METHODS: SIRS incidence within 72 hours following cardiac surgery was evaluated in a secondary analysis of children enrolled to a treatment-free control group of a randomized controlled trial. Intraoperative parameters were investigated for their association with SIRS using multivariable fractional polynomial logistic regression models. Effects of SIRS on various organ functions and length of stay were evaluated using time-varying Cox regression models. RESULTS: In 116 children after cardiac surgery (median age [range]: 7.4 month [1 day-16.2 years]) SIRS occurred in n = 39/102 with and n = 1/14 without cardiopulmonary bypass (CPB). Duration of CPB (hazard ratio [HR]: 2.28 per hour; 95% confidence interval [CI] 1.17; 4.42) and amount of fresh frozen plasma (HR: 1.23 per 10 mL/kg; 95%CI 1.06; 1.42) were identified as predictors for SIRS; neonates seemed to be less susceptible for SIRS development (HR: 0.86; 95%CI 0.79; 0.95). SIRS was associated with organ dysfunction (HR: 2.69; 95%CI 1.41; 5.12) and extended stay in the pediatric intensive care unit (PICU) (median: 168 vs. 96 hours; p = 0.007). CONCLUSIONS: SIRS is a frequent complication after pediatric congenital heart surgery; it affects nearly one third of children and prolongs PICU stay significantly. Duration of CPB and amount of fresh frozen plasma were identified as important risk factors. Neonates seem to be less susceptible to SIRS development.

In-line Filtration Decreases Systemic Inflammatory Response Syndrome, Renal and Hematologic Dysfunction in Pediatric Cardiac Intensive Care Patients.

Cardiac surgery with cardiopulmonary bypass (CPB) frequently leads to systemic inflammatory response syndrome (SIRS) with concomitant organ malfunction. Infused particles may exacerbate inflammatory syndromes since they activate the coagulation cascade and alter inflammatory response or microvascular perfusion. In a randomized, controlled, prospective trial, we have previously shown that particle-retentive in-line filtration prevented major complications in critically ill children. Now, we investigated the effect of in-line filtration on major complications in the subgroup of cardiac patients. Children admitted to tertiary pediatric intensive care unit were randomized to either control or filter group obtaining in-line filtration throughout complete infusion therapy. Risk differences and 95 % confidence intervals (CI) of several complications such as SIRS, sepsis, mortality, various organ failure and dysfunction were compared between both groups using the Wald method. 305 children (n = 150 control, n = 155 filter group) with cardiac diseases were finally analyzed. The majority was admitted after cardiac surgery with CPB. Risk of SIRS (-11.3 %; 95 % CI -21.8 to -0.5 %), renal (-10.0 %; 95 % CI -17.0 to -3.0 %) and hematologic (-8.1 %; 95 % CI -14.2 to -0.2 %) dysfunction were significantly decreased within the filter group. No risk differences were demonstrated for occurrence of sepsis, any other organ failure or dysfunctions between both groups. Infused particles might aggravate a systemic hypercoagulability and inflammation with subsequent organ malfunction in pediatric cardiac intensive care patients. Particle-retentive in-line filtration might be effective in preventing SIRS and maintaining renal and hematologic function. In-line filtration offers a novel therapeutic option to decrease morbidity in cardiac intensive care.