Results from the PRoMPT BOLUS Feasibility Pilot Clinical Trial
The PRoMPT BOLUS Feasibility Pilot Clinical Trial was performed between January and August 2018 to determine whether the feasibility of a multicenter, pragmatic randomized clinical trial to compare balanced (e.g., lactated Ringer’s) and 0.9% saline fluid resuscitation in children with suspected septic shock.
Eligible patients were >6 months to <18 years-old who were treated in the CHOP emergency department for suspected septic shock, operationalized as blood culture, antibiotics, and fluid resuscitation for abnormal perfusion. Screening, enrollment, and randomization were carried out by the clinical team as part of routine care. Patients were randomized to receive either lactated Ringer’s or 0.9% saline for up to 48 hours following randomization. Other than fluid type, all treatment decisions were at the clinical team’s discretion. Feasibility outcomes were (1) proportion of eligible patients enrolled, (2) acceptability of enrollment via the U.S. federal exception from informed consent (EFIC) regulations, and (3) adherence to randomized study fluid administration.
The key findings from this study were:
- A high proportion (85%) of eligible patients were able to be enrolled.
- Families, patients, and caregivers were supportive of enrolment through EFIC, with 43 (98%) of the 44 patients enrolled under EFIC agreeing to complete the study.
- Hospital staff were able to follow the randomization scheme to achieve strong protocol adherence with patients randomized to lactated Ringer’s receiving a median of only 20% of study fluid as 0.9% saline compared to 99% of study fluid as 0.9% saline in the saline arm (absolute difference 79%, 95% CI 48 to 85%).
These results support that it is feasible to use a pragmatic study design to study the comparative effectiveness of balanced versus 0.9% saline fluid resuscitation for pediatric septic shock.
Additional study details, including a full report of the results, can be found at: