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Oral vs Intravenous fluid therapy during Correction of Dehydration in children with Diabetic Ketoacidosis:An open label randomized controlled study

Oral vs Intravenous fluid therapy in Correction of Dehydration in children with Diabetic Ketoacidosis when pH improves to 7.25:An open label randomized controlled study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/11/059805
Enrollment
40
Registered
2023-11-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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: Oral Fluid Thaerapy: Fluid therapy will be calculated for hourly basis - frequency and will be given for a total duration of 48 hours. Oral fluid will be given once resolution of acidos

Sponsors

Dr Neha Pruthi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All Children of age less than 18 years fulfilling the case definition of diabetic ketoacidosis who present to pediatric emergency as per ISPAD guidlines -International society for pediatric and adolescent diabetes

Exclusion criteria

Exclusion criteria: Children who fail to achieve a pH?7.25 or fail to achieve a GCS >12 or children with a falling GCS by two points from baseline. Children admitted with DKA and who are partially treated in outside hospital. Children with co-morbidities where fluid therapy cannot be altered. Children with comorbidities which contraindicate oral feed. Children whose parents are not willing to consent.

Design outcomes

Primary

MeasureTime frame
Proprortion of children having successful hydration correction at the end of 48 hrs in both groups. Timepoint: Proprortion of children having successful hydration correction at the end of 48 hrs in both groups.

Secondary

MeasureTime frame
Comparative analysis of time taken by intravenous fluid versus oral fluid therapy after resolution of acidosis pH ? 7.25 in DKA to complete normalization of pH, bicarbonate, and ketonuriaTimepoint: from time of initiation of therapy to end of 48 hours of therapy

Countries

India

Contacts

Public ContactDr Neha Pruthi

PGIMS Rohtak

drnehapruthi681@gmail.com7015588334

Outcome results

None listed

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