Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: A Pilot Feasibility Study

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).

Timeline

Start

2018-01-24

Primary completion

2018-08-31

Completion

2019-01-15

Publications

• Background Weiss SL, Keele L, Balamuth F, Vendetti N, Ross R, Fitzgerald JC, Gerber JS. Crystalloid Fluid Choice and Clinical Outcomes in Pediatric Sepsis: A Matched Retrospective Cohort Study. J Pediatr. 2017 Mar;182:304-310.e10. doi: 10.1016/j.jpeds.2016.11.075. Epub 2017 Jan 4.
• Background Emrath ET, Fortenberry JD, Travers C, McCracken CE, Hebbar KB. Resuscitation With Balanced Fluids Is Associated With Improved Survival in Pediatric Severe Sepsis. Crit Care Med. 2017 Jul;45(7):1177-1183. doi: 10.1097/CCM.0000000000002365.
• Background Semler MW, Rice TW. Saline Is Not the First Choice for Crystalloid Resuscitation Fluids. Crit Care Med. 2016 Aug;44(8):1541-4. doi: 10.1097/CCM.0000000000001941. No abstract available.
• Background Young P. Saline Is the Solution for Crystalloid Resuscitation. Crit Care Med. 2016 Aug;44(8):1538-40. doi: 10.1097/CCM.0000000000001844. No abstract available.

Drugs

Indications

No indication recorded.