PRoMPT BOLUS Study

Prompt Bolus

Study Summary

Sepsis is a life-threatening emergency in children. Septic shock, the most severe form of sepsis, involves both cardiovascular and metabolic dysfunction. In Canada, approximately 4000 children are hospitalized annually for sepsis or septic shock with a median hospital length of stay of 12 days. Despite widespread implementation of resuscitation protocols, in-hospital mortality from sepsis in children in Canada remains at 5%. Intravenous (IV) fluid administration is the cornerstone of resuscitation for pediatric septic shock. Two types of crystalloid fluids are used for rapid intravascular expansion in sepsis: Normal Saline (NS) or Balanced Fluid (BF). Both, NS and BF, have proven clinical benefit in septic shock and extensive clinical application in resuscitation of critically ill patients, and are nearly universally available. However, the most effective and safest crystalloid to use for initial resuscitation of children with septic shock has yet to be established. The goal of the PRoMPT BOLUS study is to examine if in children presenting to the Emergency Department (ED) in septic shock; resuscitation with BF will result in improved clinical outcomes compared with NS. The PRoMPT BOLUS study is a multi-national clinical trial that includes 3 large pediatric emergency medicine research networks: Pediatric Emergency Research Canada (PERC), Pediatric Emergency Care Applied Research Network (PECARN – United States) and Paediatric Research in Emergency Departments International Collaborative (PREDICT – Australia/New Zealand).

Objectives

  1. To determine if fluid resuscitation with BF will improve clinical outcomes compared to fluid resuscitation with NS in pediatric septic shock
  2. To evaluate the safety of BF versus NS in pediatric septic shock
  3. To conduct a cost-effectiveness analysis alongside this clinical trial to determine the incremental costs of BF compared to NS in improving clinical outcomes in pediatric septic shock population from both a health system and societal perspective

Principal Study Investigator: Dr. Graham Thompson

Project Lead: Dr. Beata Mickiewicz

Study Team: Dr. Fran Balalmuth, Dr. Scott Weiss, Dr. Stephen Freedman, Dr. Pavan Judge, Dr. Sarah Curtis, Dr. Ahmed Mater, Dr. Karen Gripp, Dr. April Kam, Dr. Gurinder Sangha, Dr. Gary Joubert, Dr. Adrienne Davis, Dr. Anupam Sehgal, Dr. Waleed Alqurashi, Dr. Fuad Alnaji, Dr. Yasaman Shayan, Dr. Simon Berthelot, Dr. Jason Emsley, Dr. Myla Moretti, Dr. Tex Kissoon, Dr. Bram Rochwerg, Dr. Suzette Cooke