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A randomized control trial to study which crystalloid (normal saline or ringer lactate) is better for treating diabetic ketoacidosis.

To compare the effect of Normal Saline vs Ringer Lactate on resolution time of biochemical parameters in patients presenting to Department of Trauma and Emergency with Diabetic Ketoacidosis : A Randomized Control Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/077863
Enrollment
96
Registered
2024-12-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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 Health Condition 2: E101- Type 1 diabetes mellitus with ketoacidosis

Interventions

Intervention1: 0.9% Normal saline: Dose- 3 liters in first 2.5 hrs followed by 150 ml/hr
Frequency- Continous administration
Route- Intravenous
Duration- Until the resolution 0f Diabetic Ketoacidosis Control Intervention1: Ringer lactate: Dose- 3 liters in first 2.5 hrs followed by 150 ml/hr
Duration- Until the resolution 0f Diabetic Ketoacidosis

Sponsors

All India Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Meeting laboratory diagnostic criteria of diabetic ketoacidosis (As per ADA) Blood glucose greater than or equal to 250 mg/dl. pH less than 7.3. Bicarbonate less than18 mEq/L. Blood Ketones greater than or equal to 3.0 mmol/L.

Exclusion criteria

Exclusion criteria: Patients with cardiogenic shock Patients with CKD Patients with CLD Pregnant patients

Design outcomes

Primary

MeasureTime frame
Time taken for resolution of biochemical parameters in groups receiving normal saline vs ringer lactate.Timepoint: Time taken until resolution of Diabetes Ketoacidosis—

Secondary

MeasureTime frame
Change in chloride, bicarbonate, pH levels over timeTimepoint: Time taken for resolution of Diabetic ketoacidosis;Comparison of effect on clinical parameters in both study groupsTimepoint: Time taken for resolution of Diabetic ketoacidosis;Incidence of hyper/hypokalemic events during study interval.Timepoint: Time taken for resolution of Diabetic ketoacidosis—

Countries

India

Contacts

Public ContactAshok Choudhary

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, JODHPUR

ecstatic.manisha@gmail.com7042657811

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 27, 2026