acute illness in children
Conditions
Interventions
Group A : Hypotonic fluids(Na 35mEq/l) determined by the volumetirc Holliday-Segar formula.
Group B : Relatively hypertonic fluids(Na 68mEq/l : adding 10ml of 10% saline to 500ml of Group A'
s fluids ) at 80% of the Group A'
s rate.
Sponsors
National Hospital Organization Okayama Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients hospitalized with acute illness 2. Judged by the treating physician to require i.v. maintenance fluid administration for at least the following 24 h 3. A necessary clinical examination for dehydraion is confirmed before starting initial rehydraion therapy 4. Patient during or before initial rehydration therapy using normal saline or Ringer's solution(10-20ml/kg) 5. Age over 3months and under 10 years 6. Judged by the treating physician to have adequate liver/renal/cardiac function 7. Written informed concent must be obtained for the study from the parent or guardian
Exclusion criteria
Exclusion criteria: 1. Patients with serum Na <130 or >150, serum K <3.2 or >5.5 2. Patients with clinical condition lilely to develop electrolyte abnormality 3. Treatment which affect the serum sodium value is planned 4. Patients who require drugs insoluble in allocated fluids during the study period 5. Any other cases who are regarded as inadequate for study enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of hyponatremia after maintenance intravenous fluid therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Severiy of hyponatremia, clinical presentation associated with hyponatremia, with or without any other complication (2) Change of serum sodium value between before and after maintenance intravenous fluid therapy (3) Patient background-specific difference of incidence of hyponatremia (4) Discontinuation rate of maintenance intravenous fluid therapy due to side effect (5) Safety profile | — |
Countries
Japan
Contacts
Public ContactJunya Shimizu
National Hospital Organization Okayama Medical Center Department of Pediatrics
Outcome results
None listed