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Use of normal saline and half normal saline in management of complications arising from diabetes in children - an experimental study

Normal Saline Vs Half Normal Saline In Pediatric Diabetic Ketoacidosis - A Randimised Controlled Trial - DKA Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/05/018878
Enrollment
86
Registered
2019-05-01
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: Normal saline: 85 ML /KG + Maintenance IVF - [Bolus (10 ML/KG) given in first hour]over 23 hours Control Intervention1: HALF NORMAL SALINE: 85 ML /KG + MAINTAINANCE IVF - [BOLUS (10 ML/

Sponsors

Government medical college
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children admitted to department of pediatric, VIMSAR diagnosed as a case of diabetic ketoacidosis

Exclusion criteria

Exclusion criteria: 1. Pateints with intravenous fluid therapy in previous 24 to 48 hours of hospitalization 2. Patients who have already developed cerebral edema and / or AKI during admission

Design outcomes

Primary

MeasureTime frame
1. To find out the effect on electrolyte imbalance between two groups 2.TO FIND OUT THE INCIDENCE OF AKI AND CEREBRAL EDEMA BETWEEN TWO GROUPSTimepoint: 1. Estimation of serum sidium, Serum potasium, serum urea,creatinine, GCS score, blood pressure, heart rate and pupilary size at 0, 6, 24, 48 hours of hospitalization—

Secondary

MeasureTime frame
1.To find iut the duration Of hospital stays in days between two groups 2.TO FIND OUT THE MORTALITY BETWEEN TWO GROUPSTimepoint: 1.Duration of hospital stays in days till discharge or death from hospital—

Countries

India

Contacts

Public ContactSitanshu Kumar Meher

VEER SURENDRA SAI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH

drnihar.mishra@gmail.com9337797072

Outcome results

None listed

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