Skip to content

Fluid management in diabetes ketoacidosis in children

0.9% saline vs Ringer Lactate as initial fluid in children with diabetic ketoacidosis- A double blind randomized controlled trial - SARIL Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/12/029450
Enrollment
66
Registered
2020-12-01
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: Administration of 0.9% normal saline, ringer lactate: Administration of 0.9% normal saline, ringer lactate in children with diabetic ketoacidosis Control Intervention1: nil: no comparat

Sponsors

Post Graduate Institute of Medical Education and Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All children with diabetic ketoacidosis will be taken as study participants

Exclusion criteria

Exclusion criteria: Children with underlying liver disorders Children with pre-existing/ established renal disease children with symptomatic cerebral edema children with diagnosed or suspected inborn error of metabolism children with serum potassium more than 5.5meq/litre at admission

Design outcomes

Primary

MeasureTime frame
Time to resolution of acidosis(pH 7.3 and bicarbonate 15mmol/l), sensorium and closure of anion gapTimepoint: Time to resolution of acidosis(pH 7.3 and bicarbonate 15mmol/l), sensorium and closure of anion gap

Secondary

MeasureTime frame
Change in chloride levels pH Bicarbonate levels Incidence of hypokalemia and hypoglycemia in the two groups Total amount of fluid received in two groups incidence of new onset or progression of acute kidney injury in two groups Proportion of children requiring renal replacement therapy in two groups proportion of in hospital all cause mortality comparison of length of ICU/hospital stay cost analysis of interventionTimepoint: upto 28 days of enrollment

Countries

India

Contacts

Public ContactJayshree Muralidharan

Post Graduate Institute of Medical Education and Research Chandigarh

mjshree@hotmail.com9815594343

Outcome results

None listed

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