Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: A Pilot Feasibility Study
Status:
Completed
Trial end date:
2019-01-15
Target enrollment:
Participant gender:
Summary
The objective of this pilot study is to assess overall feasibility prior to embarking on a
larger randomized pragmatic trial comparing the clinical effectiveness of fluid resuscitation
with NS versus LR for pediatric patients with suspected septic shock. Necessary feasibility
assessments include ensuring appropriate compliance with study fluid in each of the two arms,
effectiveness of study enrollment using a pragmatic study design embedded within routine
clinical practice, and acceptability of using Exception from Informed Consent (EFIC).
Phase:
Phase 1
Details
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborators:
University of California, Davis University of Pennsylvania University of Utah