Rhode Island Hospital’s Hasbro Children’s Hospital Emergency Medicine and pediatric ICU departments will be enrolling its first participants this Spring in a new, international pediatric fluid resuscitation clinical research study evaluating the comparison of Normal Saline and balanced fluids solutions in children with evidence of septic shock.
The study is sponsored by the National Institutes of Health and Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania and administered through the Pediatric Emergency Care Research Network (PECARN). Pediatric Emergency Medicine physician Dr. Susan Duffy and pediatric ICU physician, Ranna Rozenfeld will lead the PRoMPT BOLUS study at Hasbro. Sepsis is a severe inflammatory response to an infection that can cause low blood pressure and “shock”. The study will compare Normal Saline and balanced fluids, which are fluids used routinely in treatment of sepsis and will evaluate for progressive renal dysfunction associated with sepsis and treatment. To participate in PRoMPT BOLUS, candidates must be between age of 6 months and 18 years old and present to the emergency department with evidence of sepsis.
Clinicians at the Rhode Island Hospital’s Hasbro Children’s Hospital will be seeking eligible candidates for the PRoMPT BOLUS study. Due to the life-threatening nature of sepsis and since early fluid initiation is critical to reverse shock, patients may be enrolled in the study through a special process for clinical trials supported by the FDA and Institutional Review Board called “Exception from Informed Consent”.
All children who present to the Hasbro Children’s Hospital Emergency Department with sepsis and meeting study criteria will be eligible to participate in this study and will be enrolled, unless opted out prior to visit. All patients enrolled in the study will receive one of the two commonly used IV fluids to treat sepsis along with the best locally available medical care available for their symptoms. Approximately 8,800 patients will be enrolled worldwide on a 1:1 basis to receive either normal saline or balanced fluids intravenous fluid.
“We are excited to be a part of this international effort to better define the care of pediatric sepsis.” said Susan Duffy, MD.
Families may elect to not have their child participate in the PRoMPT BOLUS study by completing an opt-out form online at: https://redcap.chop.edu/surveys/?s=77XTXLXMRF.