Efficacy and Safety of Recombinant Human Activated Protein C for Severe Sepsis

Author(s):  
Anna M. Ward ◽  
Richard M. Pino

This chapter provides a summary of the landmark study known as the PROWESS Study. Does treatment with DAA reduce the rate of death from any cause among patients with severe sepsis? Starting with that question, it describes the basics of the study, including funding, study location, who was studied, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, discusses implications, and concludes with a relevant clinical case. The PROWESS trial demonstrated a mortality benefit for DAA among patients with severe sepsis. However, the subsequent ADDRESS, RESOLVE, and PROWESS-SHOCK trials did not demonstrate a benefit of the medication, thus calling the results of PROWESS into question.

Author(s):  
Ryan J. Horvath ◽  
Edward Bittner

This chapter provides a summary of the landmark study known as the CORTICUS trial. Among patients suffering from septic shock, does low dose hydrocortisone improve mortality? Starting with that question, it describes the basics of the study, including funding, study location, the population studies, number of patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, discusses implications, and concludes with a relevant clinical case. The CORTICUS trial failed to demonstrate a benefit on mortality with steroid therapy among patients with septic shock. Based on CORTICUS and other studies, the Surviving Sepsis Campaign guidelines no longer recommend steroids for all patients with septic shock. Corticosteroids should be considered, however, for patients with septic shock who do not respond to fluids and vasopressor therapy.


Author(s):  
Laurie O. Mark ◽  
Jean Kwo

This chapter provides a summary of the landmark study “Comparison of 8 versus 15 days of antibiotic therapy for ventilator-associated pneumonia in adults: a randomized trial.” In adult patients with ventilator-associated pneumonia (VAP), is treatment with an 8-day course of antimicrobials as effective as a 15-day course? Starting with that question, the chapter describes the basics of the study, including funding, study location, who was studied, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, discusses implications, and concludes with a relevant clinical case. In ICU patients who develop microbiologically proven VAP, an 8-day antimicrobial course is not inferior to a 15-day course with respect to all-cause mortality or recurrence of pulmonary infection. However, these findings may not apply to patients who are immunocompromised, and shorter or longer duration of antibiotics may sometimes be indicated.


Author(s):  
Daniel Barron ◽  
Robert Ostroff

This chapter provides a summary of a landmark study on major depressive disorder. Is paroxetine or cognitive therapy more effective in treating patients with moderate to severe major depressive disorder? Starting with that question, it describes the basics of the study, including funding, study location, who was studied, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, discusses implications, and concludes with a relevant clinical case.


Author(s):  
Stephanie Yarnell ◽  
Ellen Edens

This chapter provides a summary of a landmark study in epidemiology. The Global Burden of Disease Study was a ground breaking venture in answering the question regarding the prevalence of various diseases. By analyzing this database, the current study was sought to determine the burden of disease attributable to mental and substance use disorders. With this in mind, it describes the basics of the study, including funding, study location, who was studied, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, discusses implications, and concludes with a relevant clinical case.


Author(s):  
Hardik A. Amin

This chapter provides a summary of the landmark surgical study known as the NASCET trial, which compared surgical versus nonsurgical treatment for patients with symptomatic carotid stenosis. The chapter describes the basics of the study, including funding, year study began, year study was published, study location, who was studied, who was excluded, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, gives a summary and discusses implications, and concludes with a relevant clinical case regarding vascular surgery.


Author(s):  
Jerald Borgella ◽  
Michael Choi ◽  
Miguel Burch

This chapter provides a summary of the management of patients with achalasia and how the addition of a fundoplication can affect outcomes. The primary question asked is could the addition of a Dor fundoplication to a Heller myotomy decrease the incidence of pathologic gastroesophageal reflux? Starting with that question, it describes the basics of the study, including funding, year study began, year study was published, study location, who was studied, who was excluded, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, discusses implications, and concludes with a relevant clinical case regarding treating a patient with either Heller myotomy or Heller myotomy plus partial fundoplication.


Author(s):  
Emily L. Siegel ◽  
Miguel Burch

This chapter summarizes a landmark study in treatment of gastroesophageal (GE) junction tumors. Should an anatomically based classification scheme of GE tumors define the appropriate treatment approach for these tumors? Starting with that question, it describes the basis of the study, including funding, year study began, year study was published, study location, who was studied, who was excluded, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, gives a summary and discusses implications, and concludes with a relevant clinical case involving possible gastrectomy and esophagectomy.


Author(s):  
Eric Lin ◽  
John Cahill

This chapter provides a summary of the landmark Comparison of Antipsychotics for Metabolic Problems trial on schizophrenia treatment. This trial was designed to help clarify some of the clinical considerations in choosing antipsychotics. Does switching to aripiprazole from olanzapine, quetiapine, or risperidone confer metabolic benefits? Does the switch to aripiprazole cause clinical destabilization? Starting with these questions, it describes the basics of the study, including funding, study location, study population characteristics, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, discusses implications, and concludes with a relevant clinical case.


Author(s):  
Michael E. Hochman

This chapter provides a summary of the landmark study known as the B-06 trial, which compared total mastectomy versus breast-conserving therapy (i.e., lumpectomy) for treating women with invasive breast cancer. Do all women with invasive breast cancer require a total mastectomy, or is breast conserving therapy (i.e., lumpectomy) appropriate in some women? Starting with that question, it describes the basics of the study, including funding, year study began, year study was published, study location, who was studied, who was excluded, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. The chapter briefly reviews other relevant studies and information, gives a summary and discusses implications, and concludes with a relevant clinical case involving total mastectomy versus lumpectomy.


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