Intravenous (IV) Solutions for Dehydration in Children With Gastroenteritis

Phase 4 Terminated 100 enrolled Baxter Healthcare Corporation

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study is to compare the efficacy and safety of the use of a multiple electrolyte solution to the use of saline for the treatment of moderate to severe dehydration due to acute gastroenteritis (AGE) in children.

Timeline

Start: 2011-06
Primary completion: 2013-02
Completion: 2013-02

Outcome

Met primary endpoint

Stopped (Enrollment): “Insufficient enrollment”

paper the PLA group had greater increases in serum bicarbonate from baseline than did the 0.9 % NaCl group PMID 27480410 ↗

paper change from baseline of 1.6 and 0.0, respectively; P = .004 PMID 27480410 ↗

Publications

Allen CH, Goldman RD, Bhatt S, Simon HK, Gorelick MH, Spandorfer PR, Spiro DM, Mace SE, Johnson DW, Higginbotham EA, Du H, Smyth BJ, Schermer CR, Goldstein SL. A randomized trial of Plasma-Lyte A and 0.9 % sodium chloride in acute pediatric gastroenteritis. BMC Pediatr. 2016 Aug 2;16:117. doi: 10.1186/s12887-016-0652-4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Plasmalyte A	Unknown	—	Intravenous
Comparator	sodium chloride	Unknown	—	Intravenous