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A comparative study to see the benefits of two bag treatment fluid over one bag system in children with severe diabetes

A Randomized controlled trial of one bag vs two bag system of fluid delivery in children with diabetic ketoacidosis - a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/10/005097
Enrollment
30
Registered
2014-10-14
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- patients in diabetic ketoacidosis Health Condition 2: E101- Type 1 diabetes mellitus with ketoacidosis

Interventions

Intervention1: two bag system of intravenous fluid delivery: in the two bag system of fluid delivery, dextrose will be delivered by using two intravenous bags, one bag containing only electrolytes ( N

Sponsors

Post graduate institute of medical education and research Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: children with diabetic ketoacidosis

Exclusion criteria

Exclusion criteria: Known adrenal insufficiency Steroid therapy Refusal to participate Patient partially treated outside for diabetic ketoacidosis ( received insulin therapy outside )

Design outcomes

Primary

MeasureTime frame
Blood glucose variablityTimepoint: resolution of acidosis defined by blood pH more than 7.3 and bicarbonate more than 15

Secondary

MeasureTime frame
incidence of cerebral edemaTimepoint: resolution of ketoacidosis defined by blood pH more than 7.3 and bicarbonate more than 15;incidence of hypoglycemiaTimepoint: resolution of ketoacidosis defined by blood pH more than 7.3 and bicarbonate more than 15;time to resolution of acidosisTimepoint: resolution of ketoacidosis defined by blood pH more than 7.3 and bicarbonate more than 15

Countries

India

Contacts

Public ContactNitin Dhochak

PGIMER, Chandigarh

mjshree@hotmail.com9815594343

Outcome results

None listed

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