Comparison of two type of fluids for treatment of complicated diabetes in children and adults

A multicentre cluster crossover randomized controlled trial of Normal Saline versus Ringer Lactate as fluid therapy for critically ill children and adults with Diabetic Ketoacidosis - BLESSED

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/02/081031

Enrollment

800

Registered

2025-02-20

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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: Ringerâ??s lactate: The centres will be randomised under cluster randomisation for same intervention for 12 months. Study fluid will continue for each enrolled patient until discharge f

Eligibility

Inclusion criteria

Inclusion criteria: All Patients admitted to ED/ICU with a diagnosis of DKA with all of the following criteria: Blood glucose level more than 250 mg/dl pH less than 7.25 serum bicarbonate more than 15 mmol/L Anion gap more than 12 mmol/L Ketonemia/ketonuria

Exclusion criteria

Exclusion criteria: Patients with hyperosmotic hyperglycemic non-ketotic syndrome

Design outcomes

Primary

Measure	Time frame
Hospital-free daysTimepoint: 28th day	—

Secondary

Measure	Time frame
Secondary Outcome ICU free days up to 28 days after randomisation Acute kidney injury assessed by comparing serum creatinine concentrations between groups Cerebral oedema Time to resolution of ketosis Cumulative insulin dosage in the first 48 hours Hospital mortality Tertiary Outcome Health economic analysisTimepoint: 28th day 24months	—

Countries

India

Contacts

Public ContactShani S Thankachen

PGIMER Hospital Chandigarh

mjshree@hotmail.com919815594343

Outcome results

None listed

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