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A clinical study to understand whether treatment with oral fluid therapy is better than or as good as treatment with intravenous fluid therapy in treatment of dehydration at pH values greater than or equal to 7.25 during treatment of dehydration in diabetic ketoacidosis in children.

Comparison of efficacy of oral versus intravenous fluid therapy during the correction of dehydration in children with diabetic ketoacidosis once the pH is â?¥ 7.25: an open label randomized controlled study.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/06/014472
Enrollment
40
Registered
2018-06-08
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: null- patients having diabetic ketoacidosis in paediatric age group

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

Kola Shourya Vijay Tej
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: from time of initiation of therapy to end of 48 hours of therapy—

Secondary

MeasureTime frame
Comparative analysis of time taken by intravenous fluid versus oral fluid therapy after resolution of acidosis pH â?¥ 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 ContactKola Shourya Vijay Tej

LHMC and Kalawati Saran Childrens Hospital, Delhi

drvkumar1@gmail.com9489955569

Outcome results

None listed

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