PRagMatic Pediatric Trial of Balanced vs. nOrmaL Saline FlUid in Sepsis (PRoMPT BOLUS)
This study is now recruiting.
PRagMatic Pediatric Trial of Balanced vs. nOrmaL Saline FlUid in Sepsis (PRoMPT BOLUS) is a clinical trial to compare two commonly used treatments for pediatric sepsis to see if one is more effective and safer than the other. The treatments in this study are two different intravenous fluids: normal saline and lactated Ringer’s.
Eligibility & Criteria
The PRoMPT BOLUS Feasibility Pilot Clinical Trial, performed between January and August 2018, determined 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. The key findings from this study were:
- A high proportion (85 percent) of eligible patients enrolled.
- Families, patients, and caregivers were supportive of enrolment through Exception From Informed Consent (EFIC), with 43 (98 percent) of the 44 patients enrolled under EFIC agreeing to complete the study.
- Hospital followed 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’s feasible to use a pragmatic study design to study the comparative effectiveness of balanced versus 0.9% saline fluid resuscitation for pediatric septic shock.