Hyperhydration to Improve Kidney Outcomes in Children With Shiga Toxin-Producing E. Coli Infection: A Multinational Embedded Cluster Crossover Randomized Trial

Summary

The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management).

Description

Eligibility

Age range

0–21 years

Sex

All

Healthy volunteers

No

Interventions

• Other
  Infusion of 200% maintenance fluids as balanced crystalloid IV solution

  Infusion of 200% of maintenance fluids x 24 hours provided, ideally, as a balanced crystalloid (PlasmaLyteTM, Ringer's Lactate) IV solution. Electrolytes and dextrose may be administered as required and desired by the clinical care team; customized solutions are permitted if so desired. Intravenous fluid solutions containing \< 130 mEq/L sodium may increase risk for hyponatremia and may be less effective in achieving intravascular volume expansion and should be avoided.

• Other
  Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution

  Administration of less than or equal to 110% of maintenance fluids as oral or balanced crystalloid IV solution.

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