Intravenous Fluids in Hospitalised Children

Phase 4 Completed 660 enrolled University of Oulu Oulu University Hospital · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

The main objective of the trial is to evaluate the risk of hypokalemia following administration of a isotonic solution compared to a hypotonic solution in acutely ill hospitalised children, who need intravenous fluid therapy.

Timeline

Start: 2016-10-03
Primary completion: 2019-03-31
Completion: 2019-04-15

Outcome

Missed primary endpoint

paper The risk of developing electrolyte disorder was 6.7-fold greater in children receiving isotonic fluid therapy. PMID 33104176 ↗

Publications

Lehtiranta S, Honkila M, Kallio M, Paalanne N, Peltoniemi O, Pokka T, Renko M, Tapiainen T. Risk of Electrolyte Disorders in Acutely Ill Children Receiving Commercially Available Plasmalike Isotonic Fluids: A Randomized Clinical Trial. JAMA Pediatr. 2021 Jan 1;175(1):28-35. doi: 10.1001/jamapediatrics.2020.3383.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	0.45% saline in 5% dextrose	Unknown	—	Intravenous
Subject	Plasmalyte Glucos	Unknown	—	Intravenous