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Normal saline vs balanced salt solution for resuscitation fluid in patients with DKA

A Randomized Control trial to Compare Balanced Salt Solution with Normal Saline for fluid resuscitation in pateints with Diabetic Ketoacidosis reporting to Emergency Department. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074986
Enrollment
92
Registered
2024-10-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E111- Type 2 diabetes mellitus with ketoacidosis

Interventions

Intervention1: Normal saline vs balanced salt solution: Normal saline given as intervention in one arm and BSS as comparator in other arm Control Intervention1: Balanced salt solution: Balanced salt s

Sponsors

Dr Kriti Gupta
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Fitting the ADA criteria for DKA

Exclusion criteria

Exclusion criteria: Pt with hypervolemia or conditions where giving liberal fluid is contraindicated. Pregnant women

Design outcomes

Primary

MeasureTime frame
Time of DKA resolution Resolution will be considered in correspondence to ADA guidelines for DKA. Timepoint: Assessment and assignment to DKA as per ADA guidelines at arrival of the patient to ED. Considering it as baseline values. Hourly RBS, 2nd Hourly VBG for pH, anion gap and bicarbonate values, till resolution of DKA. Resolution will be considered in correspondence to ADA guidelines for DKA.—

Secondary

MeasureTime frame
Time of insulin infusion New electrolytes changesTimepoint: Arrival to ED considered as baseline, & review after 24 hrs—

Countries

India

Contacts

Public ContactDr Kriti Gupta

AIIMS raipur

drdebendra@aiimsraipur.edu.in9329698684

Outcome results

None listed

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