DESIGN: Consensus conference. METHODS: This document describes the issues surrounding consensus on four major questions addressed at the meeting: a) How should the pediatric age groups affected by sepsis be delineated? b) What are the specific definitions of pediatric SIRS, infection, sepsis, severe sepsis, and septic shock? c) What are the specific definitions of pediatric organ failure and the validity of pediatric organ failure scores? d) What are the appropriate study populations and study end points required to successfully conduct clinical trials in pediatric sepsis? Five subgroups first met separately and then together to evaluate the following areas: signs and symptoms of sepsis, cell markers, cytokines, microbiological data, and coagulation variables. All conference participants approved the final draft of the proceedings of the meeting. RESULTS: Conference attendees modified the current criteria used to define SIRS and sepsis in adults to incorporate pediatric physiologic variables appropriate for the following subcategories of children: newborn, neonate, infant, child, and adolescent. In addition, the SIRS definition was modified so that either criteria for fever or white blood count had to be met. We also defined various organ dysfunction categories, severe sepsis, and septic shock specifically for children. Although no firm conclusion was made regarding a single appropriate study end point, a novel nonmortality end point, organ failure-free days, was considered optimal for pediatric clinical trials given the relatively low incidence of mortality in pediatric sepsis compared with adult populations. CONCLUSION: We modified the adult SIRS criteria for children. In addition, we revised definitions of severe sepsis and septic shock for the pediatric population. Our goal is for these first-generation pediatric definitions and criteria to facilitate the performance of successful clinical studies in children with sepsis. [References: 59]
AimOBJECTIVE: Although general definitions of the sepsis continuum have been published for adults, no such work has been done for the pediatric population. Physiologic and laboratory variables used to define the systemic inflammatory response syndrome (SIRS) and organ dysfunction require modification for the developmental stages of children. An international panel of 20 experts in sepsis and clinical research from five countries (Canada, France, Netherlands, United Kingdom, and United States) was convened to modify the published adult consensus definitions of infection, sepsis, severe sepsis, septic shock, and organ dysfunction for children.
ContributorsGoldstein, Brahm; Giroir, Brett; Randolph, Adrienne; and the members of the International Consensus Conference on Pediatric, Sepsis
Disease Category: Child health, Infectious disease
Disease Name: Sepsis and critical care
Age Range: 0 - 18
Sex: Either
Nature of Intervention: Not specified
- Clinical experts
- Researchers
- COS for clinical trials or clinical research
- Consensus meeting
The panel met with the goal of agreeing on definitions and criteria for the components of the sepsis continuum that could consistently be applied in the pediatric
population. In addition, the consensus conference panel discussed potential end points for clinical studies in pediatric sepsis.
The conference was held in February 2002 in San Antonio, Texas, and included 20 participants from Canada, France, the Netherlands, the United Kingdom, and the United States. During the conference the following was reviewed by all participants: the first adult consensus conference on sepsis, current available
definitions of pediatric SIRS and sepsis, organ dysfunction scoring systems used in adults and pediatrics , a review of the bactericidal/ permeability-increasing protein (rBPI21) phase III trials in meningococcemia, and a review of the Food and Drug Administration guidance for pediatric trials. The conference panel addressed four main questions:
1. How should the pediatric age groups affected by sepsis be delineated?
2. What are the specific definitions of pediatric SIRS, infection, sepsis, severe sepsis, and septic shock?
3. What are the specific definitions of pediatric organ failure and the validity of pediatric organ failure scores?
4. What are the appropriate study populations and study end points for conductof clinical trials in pediatric sepsis?
The group was split into two breakout sessions with designated discussion leaders to address the first three questions and bring forward their recommendations
to the combined group. An overall recommendation was then formed by majority opinion. The facilitated discussion on recommendations for conduct of pediatric
sepsis trials was conducted with the whole group.