Health Condition 1: null- Children aged less than 12 years admitted with diabetic ketoacidosis Health Condition 2: E101- Type 1 diabetes mellitus with ketoacidosis
Conditions
Interventions
Intervention1: Plasmalyte: A balanced crystalloid solution which is administered atleast 6 hours during initial therapy at 65- 85ml/kg with maintenance fluid requirement intravenously
Control Interven
Sponsors
Vijai Williams
Eligibility
Inclusion criteria
Inclusion criteria: All children > 1 month to 200mg/dL [to convert to millimoles perliter, multiply by 0.0555]), acidosis (pH =2+)
Exclusion criteria
Exclusion criteria: 1. Children with underlying liver disorders 2. Children with symptomatic cerebral edema 3. Children with diagnosed inborn error of metabolism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of new onset / progression of AKI that will be defined as one of the following composite outcomes: 1) change in Creatinine or urine output as per KDIGO classification (or) 2) change in GFR as calculated using Schwartz formula (or) 3) change in NGAL, as estimated at 0 and 24 hours of starting fluids Timepoint: 0 and 24 HOURS | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time to achieving end point of DKA correction 2. Time to different events (e.g. AKI, Metabolic acidosis, death etc.) 3. Change in chloride levels, pH and bicarbonate levels (baseline to 24hrs.) 4. Proportion of in hospital all-cause mortality 5. Proportion of children requiring RRT 6. Length of ICU / hospital stay. Timepoint: Time at which Resolution of DKA as defined by pH above 7.3, bicarbonate above 15mEq/L occurs | — |
Countries
India
Contacts
Public ContactVijai Williams
PGIMER
Outcome results
None listed