Articles: sepsis.
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Critical care medicine · Nov 2001
Randomized Controlled Trial Multicenter Study Clinical TrialSafety and dose relationship of recombinant human activated protein C for coagulopathy in severe sepsis.
To assess the safety and effect on coagulopathy of a range of doses of recombinant human activated protein C (rhAPC). To determine an effective dose and duration of rhAPC for use in future clinical trials. ⋯ rhAPC was safe and well-tolerated and demonstrated a dose-dependent reduction in D-dimer and interleukin 6 levels relative to placebo. The dose of 24 microg/kg/hr for 96 hrs was selected for use in future clinical studies.
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Critical care medicine · Nov 2001
Randomized Controlled Trial Multicenter Study Clinical TrialAssessment of the safety of recombinant tissue factor pathway inhibitor in patients with severe sepsis: a multicenter, randomized, placebo-controlled, single-blind, dose escalation study.
To identify a safe and potentially effective recombinant tissue factor pathway inhibitor (rTFPI) dose for further clinical evaluation in patients with severe sepsis. ⋯ Although the trial was not powered to show efficacy, a trend toward reduction in 28-day all-cause mortality was observed in the all rTFPI group compared with all placebo. This study demonstrates that rTFPI doses of 0.025 and 0.05 mg/kg/hr could be safely administered to severe sepsis patients. Additionally, rTFPI demonstrated bioactivity, as shown by reduction in TATc complexes and interleukin-6 levels. These findings warrant further evaluation of rTFPI in an adequately powered, placebo controlled, randomized trial for the treatment of severe sepsis.
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Randomized Controlled Trial Clinical Trial
Maternal epidural use and neonatal sepsis evaluation in afebrile mothers.
Epidural use has been associated with a higher rate of neonatal sepsis evaluation. Epidural-related fever explains some of the increase but not the excess of neonatal sepsis evaluations in afebrile women ⋯ Epidural analgesia is associated with increased rates of major and minor criteria for neonatal sepsis evaluations in afebrile women.
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Randomized Controlled Trial Clinical Trial
[The effect of pentaglobin therapy on prognosis in patients with severe sepsis].
This study was designed to assess the effects of polyclonal immunoglobulin administration on septic shock incidence and prognosis in patients with severe sepsis. Patients with severe sepsis were randomly allocated into two groups. One group (n = 21) received 5 ml/kg/day IgM enriched immunoglobulin preparation (Pentaglobin) for 3 days. ⋯ However, a significant decrease in procalcitonin levels were detected only in patients who received pentaglobin (p = 0.001). Mortality rate was 5/21 (23.8%) in pentaglobin group and 5/18 (27.7%) in the control group. Although pentaglobin therapy could not achieve a statistically significant improvement in septic shock occurrence and mortality, the constant reduction in procalcitonin levels indicated the beneficial effects of immunotherapy on the severity of inflammatory response to infection in severe sepsis.
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Randomized Controlled Trial Clinical Trial
Soluble fiber reduces the incidence of diarrhea in septic patients receiving total enteral nutrition: a prospective, double-blind, randomized, and controlled trial.
Attempts to control enteral nutrition associated diarrhea in the critically ill tube-fed patient by implementing feeding formulas enriched with fiber were mostly unsuccessful. Recently, it was shown that enteral feeding containing soluble partially hydrolyzed guar decreased the incidence of diarrhea in a cohort of non-critically ill medicosurgical patients. We investigated whether this type of enteral feed could also influence stool production in patients with severe sepsis, a population at risk for developing diarrhea. ⋯ Total enteral nutrition supplemented with soluble fiber is beneficial in reducing the incidence of diarrhea in tube-fed full-resuscitated and mechanically ventilated septic patients.