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A study to compare Normal Saline and Ringers Lactate for fluid therapy in children with diabetic ketoacidosis

Normal Saline versus Ringers Lactate for intravenous fluid therapy in children with diabetic ketoacidosis : A randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/02/017705
Enrollment
50
Registered
2019-02-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E101- Type 1 diabetes mellitus with ketoacidosis

Interventions

Intervention1: Ringers Lactate: Intravenous fluid therapy based on percentage of assumed dehydration and maintenance Control Intervention1: Normal Saline: Intravenous fluid therapy based on percentage

Sponsors

Dr Devanshi Singhal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Case definition for diabetic ketoacidosis has been taken as random blood glucose more than 200mg/dL, venous pH less than 7.3 or serum bicarbonate less than 15mmol/L and blood ketones more than or equal to 3mmol/L or moderate or large ketonuria

Exclusion criteria

Exclusion criteria: Children who have received partial treatment or fluid boluses from outside Children with serum sodium less than 135 mEq/L Children with serum potassium more than 5.5 mEq/L

Design outcomes

Primary

MeasureTime frame
Time taken to achieve resolution of acidosis ie pH more than or equal to 7.3 in both groupsTimepoint: Time taken to achieve resolution of acidosis ie pH more than or equal to 7.3 in both groups

Secondary

MeasureTime frame
Proportion of patients developing acute renal injuryTimepoint: 48 hours;Time taken for normalization of anion gap and blood glucoseTimepoint: 48 hours;Time taken to change type of fluidTimepoint: 48 hours;Total amount of fluid and insulin administeredTimepoint: 48 hours;Total length of stay in PICUTimepoint: 4 days;Total length of stay in the hospitalTimepoint: 2 weeks

Countries

India

Contacts

Public ContactDr Devanshi Singhal

Lady Hardinge Medical College and Associated Hospitals

sguptabhu@gmail.com9779577087

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026