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Different types of fluids used in children with complication of diabetes

Fluid management in pediatric diabetic ketoacidosis â?? Normal saline versus Ringerâ??s lactate versus balanced salt solution: a randomized double blind controlled clinical trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/02/011929
Enrollment
105
Registered
2018-02-16
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- Children with diabetic ketoacidosis

Interventions

Intervention1: Ringerâ??s lactate: Will receive the Ringerâ??s lactate via intravenous route as per fluid charting (usually 85 per kg after deduction of fluid blous if any along with routine maintenan

Sponsors

The Director
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children aged <15-year with diabetic ketoacidosis admitted to pediatric critical care unit. (DKA will be defined as per ISPAD guideline)

Exclusion criteria

Exclusion criteria: 1. Children with diabetic ketoacidosis who have already received intravenous fluid for more than four-hrs. 2. Children with a septic shock (requiring >= 60 ml/kg fluid bolus(s) and vasoactive therapy to maintain vitals parameters during initial resuscitation).

Design outcomes

Primary

MeasureTime frame
To compare the time taken for resolution of acidosis and frequency of acute kidney injury in children with diabetic ketoacidosis treated with balanced salt solution as compared to those treated with normal saline and Ringerâ??s lactate.Timepoint: During PICU and Hospital discharge (First 7 days usually).

Secondary

MeasureTime frame
1. To compare the frequency and course of acute kidney injury including an effect on acute kidney injury biomarker [Neutrophil gelatinase-associated lipocalin (NGAL) in blood and urine.Timepoint: During PICU and Hospital discharge (First 7 days usually).;2. To compare the time taken to reach the blood glucose level â?¤ 250 mg/dl.Timepoint: During PICU and Hospital discharge (First 7 days usually).;3. To compare the frequency of hyperchloremia.Timepoint: During PICU and Hospital discharge. (First 7 days usually));4. To compare the length of pediatric intensive care unit and hospital stay.Timepoint: During PICU and Hospital discharge.(First 7 days usually);5. To compare the frequency of cerebral edema and / or worsening of cerebral edema.Timepoint: During PICU and Hospital discharge.(First 7 days usually);6. To compare the cost involved Cost-effectiveness analysis among the three groups.Timepoint: During PICU and Hospital discharge.(First 7 days usually)

Countries

India

Contacts

Public ContactDR RAMESH KUMAR R

JIPMER

krramesh_iway@yahoo.co.in7373739142

Outcome results

None listed

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