Health Condition 1: R69- Illness, unspecified Health Condition 2: R688- Other general symptoms and signs
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Those sick children of the age group 28 days to 12 months who will be admitted for acute illness will require more than 50 percent of their total fluid requirement via the intravenous route for more than 24 hours.
Exclusion criteria
Exclusion criteria: Parents or patients not giving consent or assent, respectively Hemodynamic shock needing boluses or inotropes. Baseline sodium less than 135 mmol per litre or more than 145 mmol per litre, or glucose less than 54 mg per deciliter at presentation. patient receiving sodium therapy for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in serum sodium level is the primary outcome. Dysnatremia is defined as hyponatremia where serum sodium level less than 135 milliequivalent per liter and hypernatremia as serum sodium more than 145 milliequivalent per liter. At any point of dysnatremia the intervention will be stopped, participants will be withdrawn from the study, and the they will be treated as per clinician decision.Timepoint: Monitoring windows will be baseline (0 2 hours), 12 hours,24 hours and 72 hours after initiation of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum glucose is the secondary outcome.Dysglycemia is defined as hypoglycemia less than 54 milligram per deciliter, hyperglycemia is defined more than 180 milligram per deciliter. At any point of dysglycemia, the intervention will be stopped and the patient will be treated as per clinician decisionTimepoint: Monitoring windows will be baseline (0 2 hours), 12 hours,24 hours and 72 hours after initiation of therapy.;Weight gain or loss more than 10 percentage or any neurological and gastrointestinal side effects are secondary outcome. If noted, the intervention will be stopped and the patient will be treated as per clinician decision. Any derangements will be documented and corrected as per institutional protocol.Timepoint: Monitoring windows will be baseline (0 2 hours), 12 hours,24 hours and 72 hours after initiation of therapy. | — |
Countries
India
Contacts
IPGMER and SSKM hospital