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A clinical trial to compare the effect of two types of intravenous fluids, Normal Saline and 3% Saline in children with diabetic ketoacidosis

A Randomized control trial to study the effect of use of 3% saline compared to normal saline as initial fuid therapy on volume expansion in children with diabetic ketoacidosis.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/07/004751
Enrollment
40
Registered
2014-07-22
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- CHILDREN WITH DIABETIC KETOACIDOSIS

Interventions

Intervention1: 3% saline solution: Hypertonic fluid used in mangement of cerebral edema in DKA.Is also being used during resuscitation of septic shock as initial fluid. Control Intervention1: Normal S

Sponsors

KALAWATI SARAN CHILDRENS HOSPITAL AND LADY HARDINGE MEDICAL COLLEGE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Moderate to Severe Diabetic ketoacidosis: 1)Hyperglycemia(Blood sugar >200mg/dl) 2)Venous pH 3)Ketonemia/Ketonuria

Exclusion criteria

Exclusion criteria: 1)Severe acute malnutrition 2)Received IVF prior to enrollment

Design outcomes

Primary

MeasureTime frame
Improvement in circulatory volume status as defined by improvement in either state of shock or dehydration.Timepoint: At 1 hour of therapy—

Secondary

MeasureTime frame
Cerebral edemaTimepoint: 1,2,4,6,12,24,48 hours;pHTimepoint: 1,2,4,6,12,24,48 hours;SodiumTimepoint: 1,2,4,6,12,24,48 hours—

Countries

India

Contacts

Public ContactOBEID MOHAMMAD SHAFI

Lady Hardinge Medical College and Kalawati Saran Childrens Hospital

obeidshafi@gmail.com9953275633

Outcome results

None listed

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