A clinical study comparing two different types of fluids in treatment of children with diabetic ketoacidosis
Not Applicable
- Conditions
- Health Condition 1: null- Children aged less than 12 years admitted with diabetic ketoacidosisHealth Condition 2: E101- Type 1 diabetes mellitus with ketoacidosis
- Registration Number
- CTRI/2018/05/014042
- Lead Sponsor
- Vijai Williams
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All children > 1 month to < 12 years presenting to pediatric emergency with DKA will be enrolled into the study. DKA will be defined as hyperglycemia (BG >200mg/dL [to convert to millimoles perliter, multiply by 0.0555]), acidosis (pH <7.3 or bicarbonate <15mEq/L [to convert to millimoles per liter, multiply by 1]), and ketonuria (urine dipstick test result >=2+)
Exclusion Criteria
1.Children with underlying liver disorders
2.Children with symptomatic cerebral edema
3.Children with diagnosed inborn error of metabolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of new onset / progression of AKI that will be defined as one of the following composite outcomes: <br/ ><br>1) change in Creatinine or urine output as per KDIGO classification (or) <br/ ><br>2) change in GFR as calculated using Schwartz formula (or) <br/ ><br>3) change in NGAL, as estimated at 0 and 24 hours of starting fluids <br/ ><br>Timepoint: 0 and 24 HOURS <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Time to achieving end point of DKA correction <br/ ><br>2.Time to different events (e.g. AKI, Metabolic acidosis, death etc.) <br/ ><br>3.Change in chloride levels, pH and bicarbonate levels (baseline to 24hrs.) <br/ ><br>4.Proportion of in hospital all-cause mortality <br/ ><br>5.Proportion of children requiring RRT <br/ ><br>6.Length of ICU / hospital stay. <br/ ><br>Timepoint: Time at which Resolution of DKA as defined by pH above 7.3, bicarbonate above 15mEq/L occurs