Articles: sepsis.
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Clin J Am Soc Nephrol · Jan 2007
Randomized Controlled TrialElevated plasma concentrations of IL-6 and elevated APACHE II score predict acute kidney injury in patients with severe sepsis.
Acute kidney injury (AKI) is common in critically ill patients with severe sepsis (SS), and the predictors of AKI in this population have not been well characterized. The study group was the placebo group of the Prospective Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) data set. PROWESS is a prospective, randomized, controlled study of the use of drotrecogin alpha (activated) for the treatment of SS. ⋯ In a multivariable Cox regression, the predictors of AKI were log IL-6 (P < 0.0001) and APACHE II (P = 0.0008). Increased log IL-6 and APACHE II score are significant risk factors of AKI in patients with SS. IL-6 data and the absence of correlation with measures of hypotension (e.g., mean arterial pressure, dosage of vasopressors) support the notion that inflammation is a significant component of AKI in SS.
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Randomized Controlled Trial Multicenter Study
RESOLVE-ing sepsis in children--not yet!
The Researching Severe Sepsis and Organ Dysfunction in Children: A Global Perspective study of drotrecogin alpha activated versus placebo was the largest study of adjunctive therapy ever performed in children with severe sepsis. Despite this, the study failed to show any significant differences in outcome between the treatment and placebo groups. The results raise questions about how we should perform meaningful clinical trials in relatively rare conditions such as paediatric sepsis, where the easily measurable endpoints (such as death) are infrequent. A radical rethink of the design of such studies is urgently needed.
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Randomized Controlled Trial Multicenter Study
[The design of the VISEP trial. Critical appraisal].
The survey transcript of the VISEP interventional trial "Prospective randomized multicenter study on the influence of colloid vs crystalloid volume resuscitation and of intensive vs conventional insulin therapy on outcome in patients with severe sepsis and septic shock" [Clinical trials.gov. identifier: NCT00135473; study start April 2003] comprises, according to the data of the year 2003, methodological shortcomings which challenge a priori the study design and thus the resolution of the purpose of the study, i.e., "determination of the influence of the studied volume and insulin interventions on morbidity and mortality of patients with severe sepsis and septic shock". The most important points of criticism are: 1. A volume therapy with exclusively crystalloids or colloids with the chosen colloid hyperoncotic, hyperchloremic HES solution (10% hydroxyethyl starch: 10% Hemohes) or the crystalloid solution with high lactate content (Sterofundin) is neither acceptable nor practicable, even if only due to exceeding the maximum dosage as recommended by the manufacturer. 2. ⋯ It is doubtful whether an intensified insulin therapy (Actrapid) can be successful if insulin is administered simultaneously with iatrogenic hyperglycemia as a result of lactate influx. Due to these flaws in the design of the VISEP trial, the only consequence can be that the results of the survey are unusable, especially with regard to the point "HES and kidney function". Thus, any further advance presentations and interpretations should be shelved in expectation of the authors' publication of all the data, in order to begin further discussions including the flaws in study design listed here.
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Randomized Controlled Trial
Randomized controlled trial of 7-Day vs. 14-Day antibiotics for neonatal sepsis.
There are no evidence-based guidelines available regarding the duration of antibiotics in neonatal septicemia. We compared the effectiveness of a 7-day intravenous antibiotic regimen with the standard 14-day regime in blood-culture-proven sepsis in neonates. This was a controlled, blinded, randomized trial with stratification (for birth weight). ⋯ Neonates > or =32 weeks and/or > or =1500 g with S. aureus sepsis require 14 days of antibiotics. S. aureus infection is also associated with failure to achieve clinical remission by the 5th day of antibiotic therapy. Larger trials are required to confirm whether neonates with non-S. aureus sepsis, whose symptoms remit by 5 days, can be treated with 7 days of antibiotics.
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Randomized Controlled Trial
Serum IL-6 and IL-1-ra with sequential organ failure assessment scores in septic patients receiving high-volume haemofiltration and continuous venovenous haemofiltration.
Sepsis is characterized by an uncontrolled release of pro-inflammatory and anti-inflammatory mediators leading to immunoparalysis, cellular and humoral dysfunction, multiorgan dysfunction and death. This study evaluated the efficacy of high-volume haemofiltration (HVHF) compared with continuous venovenous haemofiltration (CVVH) in removing these inflammatory mediators. Clinical responses were assessed with the sequential organ failure assessment (SOFA) score. ⋯ High-volume haemofiltration at 6 L/h may seem to successfully remove some inflammatory cytokines in septic patients. The improvement in the SOFA scores at day 7 promises benefit of continuous renal replacement therapy in septic patients, but after 20 days this effect may be lost. In addition, the baseline serum IL-6 and IL-1-ra were independent predictors of a poor outcome as reflected by the higher SOFA scores at day 1.