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

Completed

Conditions: Type 1 diabetes mellitus with ketoacidosis,

Registration Number: CTRI/2019/02/017705

Lead Sponsor: Dr Devanshi Singhal

Brief Summary: This is a triple blind randomized controlled trial comparing the efficacy of Ringerâ€™s Lactate and Normal Saline for intravenous fluid therapy in 50 children with diabetic ketoacidosis, 25 children in each group. The study will be conducted in Kalawati Saran Childrenâ€™s Hospital, New Delhi, India.The primary outcome measure will be time taken for resolution of acidosis ie venous pH more than or equal to 7.3 in both groups. Secondary outcome measures will be proportion of patients developing acute renal injury within the study period, time taken for normalization of anion gap and blood glucose, time taken to change type of fluid, total amount of fluid and insulin administered and total length of stay in PICU and in the hospital.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 50

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time taken to achieve resolution of acidosis ie pH more than or equal to 7.3 in both groups	Time taken to achieve resolution of acidosis ie pH more than or equal to 7.3 in both groups

Secondary Outcome Measures

Name	Time	Method
Time taken for normalization of anion gap and blood glucose	48 hours
Total amount of fluid and insulin administered	48 hours
Total length of stay in PICU	4 days
Total length of stay in the hospital	2 weeks
Proportion of patients developing acute renal injury	48 hours
Time taken to change type of fluid	48 hours

Trial Locations

Locations (1): Kalawati Saran Childrens Hospital
🇮🇳
Delhi, DELHI, India
Kalawati Saran Childrens Hospital
🇮🇳Delhi, DELHI, India
Dr Devanshi Singhal
Principal investigator
9899687871
devanshi_singhal@yahoo.co.in