Critical care medicine
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Critical care medicine · Mar 2003
Randomized Controlled Trial Multicenter Study Clinical TrialEffects of drotrecogin alfa (activated) on organ dysfunction in the PROWESS trial.
To assess morbidity in patients with severe sepsis managed with and without drotrecogin alfa (activated). ⋯ Drotrecogin alfa (activated) demonstrated significant improvements in organ function compared with placebo in a large phase 3 clinical trial that has shown a mortality benefit in patients with severe sepsis.
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Critical care medicine · Mar 2003
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialEfficacy and safety of LY315920Na/S-5920, a selective inhibitor of 14-kDa group IIA secretory phospholipase A2, in patients with suspected sepsis and organ failure.
Concentrations of group IIA secretory phospholipase A, an inflammatory response mediator, are increased in the plasma of patients with sepsis and septic shock, and the extent of elevation is correlated with mortality. LY315920Na/S-5920 is a selective inhibitor of group IIA secretory phospholipase A that has been shown to inhibit serum group IIA secretory phospholipase A enzyme activity in patients with severe sepsis. The primary objectives of this study were to determine whether there was a dose-response relationship between two doses of LY315920Na/S-5920 compared with placebo in the reduction of 28-day all-cause mortality in patients with severe sepsis and to determine whether LY315920Na/S-5920 had an acceptable safety profile.(2) (2) (2) ⋯ Administration of LY315920Na/S-5920 had an acceptable safety profile in patients with severe sepsis. There was no overall survival benefit associated with the use of LY315920Na/S-5920 in this study. However, prospectively planned secondary analyses suggested that treatment with LY315920Na/S-5920 was associated with an improvement in survival in patients treated within 18 hrs of the first sepsis-induced organ failure.
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Critical care medicine · Mar 2003
Comparative StudyHospital mortality rate and length of stay in patients admitted at night to the intensive care unit.
Although admission of patients to a medical ward after 5:00 pm has been associated with increased mortality rate and possibly shorter hospital stay, the association between timing of admission to the intensive care unit and outcome has not been studied. The objective of this study was to determine whether there are any associations between the timing of patient admission to a medical intensive care unit and hospital outcome. ⋯ Nighttime admission to our intensive care unit is not associated with a higher mortality rate or a longer hospital or intensive care unit stay compared with daytime admission.
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Critical care medicine · Mar 2003
ReviewEthical framework for the use of sham procedures in clinical trials.
Ethical, professional, and financial considerations support the highest standards in demonstrating the safety and efficacy of new clinical interventions. Professional and regulatory mechanisms implemented to ensure that medical agents undergo a thorough process of systematic testing are lacking in the case of medical procedures. ⋯ We examine the major ethical objections to placebo-controlled procedure trials, including those involving sham surgery, and provide an ethical framework for assessing whether a placebo procedure is ethical to administer in the context of a clinical trial. A placebo-controlled trial of an invasive procedure can be ethically justified if: 1) there is a valuable, clinically relevant question to be answered by the research, 2) the placebo control is methodologically necessary to test the study hypothesis, 3) the risk of the placebo control itself has been minimized, 4) the risk of a placebo control does not exceed a threshold of acceptable research risk, 5) the risk of the placebo control is justified by valuable knowledge to be gained, and 6) the misleading involved in the administration of a placebo control is adequately disclosed and authorized during the informed consent process.
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Critical care medicine · Mar 2003
ReviewIs the concept of informed consent applicable to clinical research involving critically ill patients?
Informed consent is a process through which patients or their surrogates authorize medical interventions or involvement in research. The concept of informed consent is supported by ethical principles and legal tradition in the United States. It grew in importance during the 20th century because of documented abuse of research subjects, which led to its codification in federal consent requirements for clinical research. ⋯ For these and other reasons, it has been argued that the concept of informed consent is not applicable to clinical research involving the critically ill and that such consent is not necessary in certain circumstances. Yet, for all its inadequacies, the concept of informed consent and the federal consent requirements should be retained because they promote respect for patients and their right of self-determination and because investigator discretion is not adequate. Stronger research oversight may be as important as informed consent in protecting patient welfare.