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Diagnostic Value of Cytokines in Neonatal Sepsis

Diagnostic Value of Cytokines in Neonatal Sepsis. Statistical Data from Germany. Population Size 82 Mio. Deliveries (1999) 770.000 Cases of Neonatal Sepsis In All Newborns 0,1 % Preterm Delivered Newborns 1-2 % . Definition of Neonatal Sepsis. Blood culture positive

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Diagnostic Value of Cytokines in Neonatal Sepsis

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  1. Diagnostic Value of Cytokines in Neonatal Sepsis

  2. Statistical Data from Germany Population Size 82 Mio. Deliveries (1999) 770.000 Cases of Neonatal Sepsis In All Newborns 0,1 % Preterm Delivered Newborns 1-2 %

  3. Definition of Neonatal Sepsis • Blood culture positive • Maternal history • Clinical signs • CRP > 10 mg/L

  4. Diagnostic Value of CRP in EOBI Specificity and sensitivity of increasing CRP levels and time after admission (Mathers and Pohlandt, Eur J Pediatr, 1987)

  5. Time Course of IL-6/IL-8 and CRP Synthesis of an Experimentally Induced Sepsis LPS = IL-8 = IL-6= CRP Concentration 0 12 24 48 72 96 120 h

  6. Sensitivity of IL-6 and CRP on Admission in Infected Newborns* * Values are percentages IL-6 CRP IL-6 (Negative CRP on Admission) Blood culture positive sepsis (n=11) 73 73 100 Clinical sepsis (n=15) 87 60 100 Infection without positive blood culture (n=41) 68 54 74 Total (n=67) 73 58 82 (Buck, C. et al., Pediatrics, 1994)

  7. IL-6 and CRP Alone or in Combination ³ IL-6 50 pg/mL ³ ³ IL-6 50 pg/mL CRP 10 mg/L and/or ³ CRP 10 mg/L Sensitivity [%] 61 63 96 Specificity [%] 76 97 74 PPV [%] 38 83 49 NPV [%] 89 91 99 Values are calculated among neonates with infection and neonates with negative sepsis workup (Doellner et al., The Journal of Pediatrics, 1998)

  8. 1.0 4* 3* 0.9 2* 0.8 1* 1 0.7 0.6 0.5 0.4 0.3 0.2 0.1 0.0 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 ROC-Curve: IL-8 for Early-Onset Infection in 342 Neonates with CRP < 10 mg/L * 1. IL-8 = 137 pg/mL Se.: 77 % [61-88] Sp.: 89 % [85-93] * 2. IL-8 = 86 pg/mL Se.: 86 % [72-95] Sp.: 82 % [77-86] * 3. IL-8 = 78 pg/mL Se.: 88 % [75-96] Sp.: 79 % [74-84] * 4. IL-8 = 68 pg/mL Se.: 91 % [78-97] Sp.: 76 % [70-80] Sensitivity 1 -Specificity (Pohlandt, F., Personal Communication 1998)

  9. IL-8, CRP, IL-8 and/or CRP, and ITR for the Diagnosis of EOBI in 389 Newborn Infants with Suspected EOBI IL-8 > 70 pg/mL CRP > 10 mg/L IL-8 > 70 pg/mL ITR > 0.20 ITR > 0.20 and / or and / or CRP > 10 mg/L CRP > 10 mg/L SE 77 % 37 % 91 % 81 % 89 % SP 76 % 95 % 74 % 45 % 41 % PPV 42 % 63 % 43 % 23 % 24 % NPV 94 % 87 % 98 % 92 % 94 % (Pohlandt, F., Personal Communication 1998)

  10. Cost-Effectiveness Analysis for the Replacement of the Differential Blood Count by IL-8 in 389 Patients with Suspected EOBI Antibiotic Therapy Antibiotic Therapy Antibiotic Therapy on the Basis of on the Basis of Symptoms on the Basis of Symptoms Symptoms and/or and/or maternal History and/or maternal History maternal History and either an ITR > 0,20 and either an IL-8 > 70 pg/mL or a CRP > 10 mg/L or a CRP > 10 mg/L IL-8 - - 389 x 21.-- Differential - 389 x 10.-- - Blood Count CRP - 389 x 2.-- 389 x 2-- Unnecessary 319 x 28.-- 221 x 28.-- 92 x 28.-- Blood Cultures Unnecessary i.v. - 319 x 16.-- 221 x 16.-- 92 x 18.-- Lines for 2 Days Unnecessary 319 x 12.-- 221 x 12.-- 92 x 12.-- Antibiotic Therapy for 2 Days 17864.-- 17044.-- 14099.-- (Pohlandt, F., Personal Communication 1998)

  11. ROC-Curve: IL-8 for Suspected Nosocomial Infection 264 Episodes in 117 Neonates (CRP < 10 mg/L) 1.0 3* 0.9 2* 0.8 1* * 1. IL-8 = 70 pg/mL Se.: 77 % [58-90] Sp.: 90 % [85-93] * 2. IL-8 = 53 pg/mL Se.: 83 % [65-83] Sp.: 82 % [77-87] * 3. IL-8 = 42 pg/mL Se.: 90 % [74-98] Sp.: 69 % [63-75] 0.7 0.6 Sensitivity 0.5 0.4 0.3 0.2 0.1 0.0 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1 - Specificity (Pohlandt, F., Personal Communication 1998)

  12. IL-8, CRP, IL-8 and / or CRP, and ITR for theDiagnosis of NBI in 304 Episodes of Suspected NBI in 132 Hospitalized Newborn Infants IL-8 > 53 pg/mL CRP > 10 mg/L IL-8 > 53 pg/mL ITR > 0.20 ITR > 0.20 + / - and / or CRP > 10 mg/L CRP > 10 mg/L SE 79 % 50 % 92 % 88 % 90 % SP 81 % 96 % 78 % 43 % 40 % PPV 53 % 74 % 51 % 28 % 27 % NPV 93 % 89 % 97 % 94 % 94 % (Pohlandt, F., Personal Communication 1998)

  13. Cost-Effectiveness Analysis for the Replacement of Differential Blood Count by IL-8 in 304 Patients with Suspected NBI Antibiotic Therapy Antibiotic Therapy Antibiotic Therapy on the Basis of on the Basis of Symptoms on the Basis of Symptoms Symptoms and either an ITR > 0,20 and either an IL-8 > 70 pg/mL or a CRP > 10 mg/L or a CRP > 10 mg/L IL-8 - - 304 x 21.-- Differential - 304 x 10.-- - Blood Count CRP - 304 x 2.-- 304 x 2-- Unnecessary 243 x 28.-- 164 x 28.-- 30 x 28.-- Blood Cultures Unnecessary i.v. - 243 x 16.-- 164 x 16.-- 30 x 16.-- Lines for 2 Days Unnecessary 243 x 15.-- 164 x 15.-- 30 x 15.-- Antibiotic Therapy for 2 Days 14337.-- 13324.-- 8762.-- (Pohlandt, F., Personal Communication 1998)

  14. 1.0 2* 0.9 1* 0.8 0.7 0.6 Sensitivity 0.5 0.4 0.3 0.2 0.1 0.0 0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 1 - Specificity ROC-Curve: IL-8 for Suspected EOBI in62 Premature Infants Gestat. Age < 30 Weeks) with CRP < 10 mg/L on Admission * 1. IL-8 = 255 pg/mL Se.: 83 % [52-98] Sp.: 84 % [71-93] * 2. IL-8 = 176 pg/mL Se.: 92 % [62-100] Sp.: 70 % [55-82] (Pohlandt, F., Personal Communication 1998)

  15. Combination of IL-8 and / or CRP for the Diagnosis of EOBI in 68 Preterm Infants (Gestat. Age < 30 Weeks) at Various Cut-Points for IL-8 IL-8 > 234 pg/mL IL-8 > 176 pg/mL IL-8 > 70 pg/mL and/or CRP > 10 mg/L and/or CRP > 10 mg/L and/or CRP > 10 mg/L SE 88 % 94 % 100 % SP 84 % 71 % 46 % PPV 67 % 50 % 36 % NPV 93 % 97 % 100 % (Pohlandt, F., Personal Communication 1998)

  16. IL-8, CRP, IL-8 and / or CRP, and ITR for the Diagnosis of EOBI in 68 Preterm Infants (Gestat. Age < 30 Weeks) IL-8 > 70 pg/mL CRP > 10 mg/L IL-8 > 70 pg/mL ITR > 0.20 ITR > 0.20 and / or and / or CRP > 10 mg/L CRP > 10 mg/L SE 94 % 25 % 100 % 86 % 86 % SP 46 % 100 % 46 % 49 % 49 % PPV 35 % 100 % 36 % 34 % 34 % NPV 96 % 75 % 100 % 92 % 94 % (Pohlandt, F., Personal Communication 1998)

  17. Severely Ill YES NO Evaluation of IL-8 and CRP YES YES YES NO NO NO IL-8 for the Diagnosis of Neonatal Bacterial Infection- Flow Sheet - Admission Clinical Evaluation Treatment T i m e Treatment Reevaluation after 12-36 hours Treatment Reevaluation after 36-60 hours Treatment No Treatment (Pohlandt, F., Personal Communication 1998)

  18. Comparison of Sensitivities of IL-6 and IL-8 (According to the Present Investigation) Sensitivity IL-6 > 10 pg/mL IL-8 > 70 pg/mL IL-6 > 10 pg/mL IL-8 > 70 pg/mL and/or and/or CRP > 10 mg/L CRP > 10 mg/L Culture proven Sepsis 73 % 88 % 100 % 88 % (EOBI) All Infections 72 % 77 % 93 % 91 % (EOBI) (Pohlandt, F., Personal Communication 1998)

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