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Alternative outcome measures for pediatric clinical sepsis trials

Curley, Martha A. Q. RN, PhD, FAAN; Zimmerman, Jerry J. PhD, MD, FCCN

Pediatric Critical Care Medicine: May 2005 - Volume 6 - Issue 3 - pp S150-S156
The Study of Pediatric Sepsis

Objective: To review nonmortality outcome measures in clinical trials of therapies to treat sepsis in children.

Data Source: Literature review using the search word terms “sepsis” + “surrogate markers,” “sepsis” + “biomarkers,” or “sepsis” + “outcomes.”

Study Selection: Articles were generally categorized as those dealing with review of patient-centered outcomes, characteristics of good surrogate markers, resolution of organ dysfunction, morbidity and functional status, quality-of-life measures, intensive care unit costs, and biomarkers.

Data Extraction and Synthesis: Information potentially relevant for development of surrogate markers for pediatric sepsis trials was extracted and organized as noted above.

Conclusions: Multiple potential surrogate markers are being actively investigated for their potential validity and utility in pediatric clinical trials of sepsis and increasingly for adult sepsis trials. This is important because as mortality decreases, it becomes an impractical primary end point. Surrogate end points that address patient-related morbidity and intensive care unit costs may also be quantified. Treatment of sepsis and corresponding end points for clinical trials should be aimed at both the duration and the quality of survival.

From Children’s Hospital Boston, Boston, MA (MAQC); and Children’s Hospital and Regional Medical Center, Seattle, WA (JJZ).

This work was supported by the Mannion Family Fund—Center for the Critically Ill Child, Division of Critical Care Medicine at Children’s Hospital Boston, the PALISI Network, and the ISF.

©2005The Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies