Literature DB >> 8355388

The clinical evaluation of new drugs for sepsis. A prospective study design based on survival analysis.

W A Knaus1, F E Harrell, C J Fisher, D P Wagner, S M Opal, J C Sadoff, E A Draper, C A Walawander, K Conboy, T H Grasela.   

Abstract

OBJECTIVE: To develop a survival model and severity assessment method to estimate the 28-day mortality risk for patients with sepsis syndrome entering phase 2 and 3 drug evaluations.
DESIGN: Retrospective analysis of intensive care unit admissions with sepsis syndrome by means of log-normal regression to identify risk factors for 28-day mortality. Prospective application of the model to patients with gram-negative infection meeting sepsis syndrome criteria from separate data collection (validation group). PATIENTS: A total of 58,737 intensive care unit admissions at 107 hospitals in the United States and Western Europe screened to yield 1195 patients meeting entry criteria for the sepsis syndrome study for the original model; 295 hospitalized patients with gram-negative infection meeting criteria for sepsis syndrome for validation. MAIN OUTCOME MEASURES: Survival time and mortality at 28 days after fulfillment of the sepsis syndrome criteria.
RESULTS: Acute physiologic abnormalities were the most important prognostic factors influencing outcome (82% of total chi 2). Specific disease resulting in intensive care unit admission and the time the patient was in the hospital and intensive care unit before qualification were also independent risks, as were age and a clinical history of cirrhosis. The model's overall classification accuracy was a Somers' Dyx of .52 (rank correlation between predicted risk and 28-day mortality) (receiver operating characteristic area, 0.76), with equal accuracy (Dyx = .59; receiver operating characteristic area, 0.80) in the independent group of patients.
CONCLUSIONS: We created an accurate independent estimate for 28-day mortality risk for patients with sepsis syndrome (severe sepsis). This estimate could improve the evaluation of new drugs by investigating whether the drug's benefit varies by patient risk and then determining the amount of benefit for individual patients.

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Year:  1993        PMID: 8355388

Source DB:  PubMed          Journal:  JAMA        ISSN: 0098-7484            Impact factor:   56.272


  18 in total

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Authors:  Jean-Roger Le Gall
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Review 2.  Identifying patients with ARDS: time for a different approach.

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Review 3.  Immunotherapy in the management of sepsis.

Authors:  E A Fagan; M Singer
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5.  Meningococcal disease: a comparison of eight severity scores in 125 children.

Authors:  H H Derkx; J van den Hoek; W K Redekop; R P Bijlmer; S J van Deventer; P M Bossuyt
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6.  Clinical correlates to laboratory measures for use in non-contact anterior cruciate ligament injury risk prediction algorithm.

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7.  Application of the APACHE III prognostic system in Brazilian intensive care units: a prospective multicenter study.

Authors:  P G Bastos; X Sun; D P Wagner; W A Knaus; J E Zimmerman
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8.  EPISEPSIS: a reappraisal of the epidemiology and outcome of severe sepsis in French intensive care units.

Authors:  C Brun-Buisson; P Meshaka; P Pinton; B Vallet
Journal:  Intensive Care Med       Date:  2004-03-02       Impact factor: 17.440

9.  Prevalence of occult adrenal insufficiency and the prognostic value of a short corticotropin stimulation test in patients with septic shock.

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10.  Prognostic factors of survival time after hematopoietic stem cell transplant in acute lymphoblastic leukemia patients: Cox proportional hazard versus accelerated failure time models.

Authors:  Kourosh Sayehmiri; Mohammad R Eshraghian; Kazem Mohammad; Kamran Alimoghaddam; Abbas Rahimi Foroushani; Hojjat Zeraati; Banafsheh Golestan; Ardeshir Ghavamzadeh
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