Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection

Conditions

• Hemolytic-Uremic Syndrome
• Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection

Eligibility Criteria

Sex

ALL

Age

9 Months - 21 Years

Healthy Volunteers

Not accepted

Interventions

• Infusion of 200% maintenance fluids as balanced crystalloid IV solution — OTHER
  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.
• Oral fluids; infusion of up to 110% maintenance fluids as balanced crystalloid IV solution — OTHER
  Administration of less than or equal to 110% of maintenance fluids as oral or balanced crystalloid IV solution.

Study Details

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).

Key Dates

Start date

Sep 29, 2022

Status verified

May 2026

Primary completion

Aug 31, 2027

Completion

Aug 31, 2028

Study Design

Enrollment

1,040 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Hyperhydration
  In this study arm, all eligible children are admitted for the administration of intravenous fluids. The following specifics will form the basis of the fluid management protocol: 1. Reversal of dehydration: Initial ED rehydration strategies should focus on rapidly reversing dehydration. 2. Infusion of 200% of maintenance fluids x 24 hours 3. If hematocrit reduction \< 20% from initial value, repeat step #2 \[infusion of 200% maintenance fluids x 24 hours\]. 4. Oral fluids permitted ad lib. 5. Once the target hematocrit reduction is achieved (20% decrement in initial HCT) AND a 10% weight gain, adjust total IV fluid volume to maintain targeted weight gain: insensible plus output (i.e., urine plus stool).
• Active Comparator: Conservative Fluid Management
  The conservative fluid management arm has been designed to align and integrate into existing local practice patterns. Implementation of this approach will allow institutions and their practitioners to choose their management of protocol eligible children. All children will undergo a protocolized baseline evaluation that includes reversal of dehydration (if present) and follow-up plan (see Pre-Pathway care). The fluid management decision in the ED (i.e., to treat dehydration) will be at the discretion of the clinical care team. In the absence of evidence of microangiopathy (i.e., normal urinalysis, LDH, hemoglobin and platelet counts, and creatinine concentrations), the decision to admit the child to hospital or discharge the child to home will be at the discretion of the clinical care team. If microangiopathy is present (i.e., abnormal urinalysis, LDH, hemoglobin or platelet counts, or creatinine concentrations) admission for monitoring will be required.

Primary Outcome Measure

Major Adverse Kidney Events by 30 days (MAKE30) [ Time Frame: 30 days ]

Central Contacts

• Study Manager
  (801) 581-6410
  [email protected]

Locations (22)

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