Hasbro Children’s Hospital Participates in Global Study of Sepsis Treatments
Pediatric Emergency Medicine physician Susan Duffy, MD, MPH, director of pediatric special projects, and pediatric intensivist Ranna Rozenfeld, MD, are leading the PRoMPT BOLUS study at Hasbro Children’s Hospital.
This spring, Rhode Island Hospital’s Hasbro Children’s Hospital emergency medicine department and pediatric intensive care unit are enrolling the first participants in an international clinical research study comparing the efficacy of normal saline and balanced fluids (including lactated Ringer’s and PlasmaLyte) in children with evidence of septic shock.
The study is sponsored in the United States by the National Institutes of Health and Children’s Hospital of Philadelphia, Pennsylvania, and is administered through the Pediatric Emergency Care Research Network (PECARN). Also participating are hospitals are in Australia, New Zealand, and Canada.
The PRagMatic Pediatric Trial of Balanced vs. nOrmaL Saline FlUid in Sepsis study will compare the efficacy of administering normal saline and balanced fluids, which are used routinely in treatment of sepsis, and will evaluate for progressive renal dysfunction associated with sepsis and treatment.
Although most patients with sepsis in PECARN emergency departments receive normal saline fluid resuscitation, a larger proportion of patients in PECARN PICUs receive balanced fluid resuscitation because new data suggest it may be more effective in treating sepsis.
Because suspected sepsis requires immediate treatment, we anticipate that, in most cases, it will not be possible to obtain informed consent from patients or their legally authorized representative before they are enrolled. Therefore, eligible patients will be enrolled under the U.S. Food and Drug Administration’s exception from informed consent (EFIC) requirements for emergency research (21 CFR 50.24).
These rules allow research studies in certain emergency situations to be conducted without consent. EFIC can only be used when the person’s life is at risk, the best treatment is not known, the study might help the person, and it is not possible to obtain informed consent from the patient or a legally authorized representative.
All resuscitative and maintenance fluids will be given as study fluids for up to two days after enrollment unless the treating team judges it unsafe for the patient to continue in the study. All other care will be standard and determined by the treatment team per routine. Patients will be followed by study personnel through 90 days or discharge from the hospital, whichever comes first.
As you may know, sepsis is associated with significant organ dysfunction leading to important morbidity and, too often, death. We believe this study may help physicians treat sepsis in the future with a simple and low-cost practice change if we are able to determine whether NS or BF is more effective for resuscitation.
All children who present to the Hasbro Children’s Hospital Emergency Department with sepsis and who meet study criteria will be enrolled, unless opted out before their visit. Approximately 8,800 patients in all will be enrolled in PRoMPT BOLUS. Parents may opt their child out of the PRoMPT BOLUS study by visiting the study's website.
To participate in the study, candidates must be more than 6 months and less than 18 years old and present to the emergency department with evidence of sepsis.