Computational protocol: The prognostic value of procalcitonin, C reactive protein and cholesterol in patients with an infection and multiple organ dysfunction

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Protocol publication

[…] A prospective case-control study was performed on 67 patients (39 males and 28 females; age, 18–85; mean 58; range, 44–66 years) treated at the intensive care unit (ICU) during 2010–2015.This study was approved by the Ethics Committee of Mogilev Regional Hospital, and all patients gave written informed consent upon admission to the ICU.Inclusion criteria were: 1) presence of two or more clinical or laboratory signs of systemic inflammatory response syndrome; 2) presence of an established infection site; 3) presence of dysfunction in two or more organ systems: arterial hypoxemia (PaO2/FIO2 < 300 mmHg); oliguria (urine output < 0.5 ml/kg/h for at least 2 h); plasma urea ≥ 45 mmol/L; creatinine > 2.0 mg/dl; coagulation abnormalities (International Normalized Ratio > 1.5 or activated partial thromboplastin time > 60 s; ileus; thrombocytopenia < 100,000 platelets/µl); inadequate tissue perfusion (lactic acidemia > 2 mmol/L); hyperbilirubinemia (plasma total bilirubin > 70 mmol/L); altered mental status; arterial hypotension (systolic blood pressure < 90 mmHg or mean arterial pressure < 70 mmHg); 4) either sex; and 5) aged > 18 years.The exclusion criteria were: 1) chronic cardiovascular or decompensated respiratory failure; 2) stage 5 chronic kidney disease and undergoing hemodialysis; 3) hepatic cirrhosis or chronic liver failure; 4) immunodeficiency; 5) glucocorticoid treatment; 6) hypolipidemic treatment; 7) AIDS; 8) metastatic cancer; 9) lymphoma; 10) leukemia; or 11) multiple myeloma.The patient demographics are presented in .The underlying medical conditions of the patients are listed in . The immediate reason for hospitalization was the development of organ dysfunction that required hemodynamic support with vasoactive and inotropic agents, or mechanical ventilation, among others. These medical conditions occurred within 4–22 days after disease onset (mean, 7.2 ± 5.1 days). The patients received treatment in accordance with protocols adopted in the Republic of Belarus for each individual nosology; additional support of organs and systems was provided depending on the dysfunction.Pathological flora was isolated from biological media during bacteriological studies in all patients; from sputum in 55 patients (81.1%), from urine in 42 patients (62.7%), from blood in 39 patients (58.2%), from wound exudate in 24 patients (35.8%), from drainage tube discharge in 22 patients (32.8%), from liquor in four patients (6.0%), and from the catheter tip in three patients (4.5%).PCT, CRP, and cholesterol levels were determined in all patients on admission and during the treatment course. Blood sampling was performed from 8:00 to 9:00 AM, on an empty stomach, and from a peripheral vein not used for infusion therapy. Intravenous fat emulsions were discontinued before and during blood sampling. Whole blood was delivered to the laboratory where the analysis was carried out within 1 h. Cholesterol and CRP levels were determined using the AU 680 biochemical analyzer (Beckman Coulter, Brea, CA, USA). Enzymatic and immunoturbidimetric methods were used to determine cholesterol and CRP levels, respectively. Before sampling, the device was calibrated using the system calibrator sets and quality control was performed using reference sera. PCT levels were determined using the EasyReader immunochromatographic rapid test analyzer (Vedalab, Cerisé, France) and a set of PROCAL-CHECK-1 reagents were used for calibration.Compliance with the normal distribution was determined by the Shapiro–Wilks test. Differences between the independent and dependent variables between the groups were determined using the Mann-Whitney and Wilcoxon tests, respectively. To assess the degree of dependence between the variables, Spearman's correlation coefficient R analysis was applied. The associations between the markers and mortality as a dependent variable were assessed by logistic regression analysis. A receiver operating characteristic (ROC) curve was plotted and the area under the ROC curve (AUC) was assessed as well as sensitivity and specificity to evaluate the discriminatory power of the markers for predicting mortality. The bioscore system for mortality was analyzed for the AUC, and the subsequent ROC curves were used to evaluate prognostic value. The Youden index was applied to set the cut-offs and was compared between the evaluation methods.Data are presented as mean and SD (normal distribution), median and quartiles (non-normal distribution), or as percentages for categorical variables. The Statistica 7.0 (Statsoft Inc., Tulsa, OK, USA) and SPSS (SPSS Inc., Chicago, IL, USA) software packages were used for analyses. Differences were considered significant at P < 0.05. […]

Pipeline specifications

Software tools Statistica, SPSS
Application Miscellaneous
Organisms Homo sapiens
Chemicals Cholesterol