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Trial of two different fluids for diabetic ketoacidosis

Randomised, controlled trial of Hartmann's solution versus saline in diabetic ketoacidosis in children

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12611000653965
Enrollment
60
Registered
2011-06-27
Start date
2007-10-15
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We want to know the best type of intravenous (drip) fluid to give children with diabetic ketoacidosis. There are several kinds of intravenous fluids commonly given to children with diabetic ketoacidosis. The commonest one is normal saline, which is salt dissolved in water. This is the one we use at the Women’s and Children’s hospital. Another fluid sometimes used is called Hartmann’s solution, which contains salt and another substance, lactate, to prevent the build up of acid (acidosis) in the blood that can be caused by too much salt. One difference between different fluids could be their effect on the recovery from acidosis. All children with diabetic ketoacidosis have acidosis when they are admitted. As they recover from this kind of acidosis, some develop another kind of acidosis, perhaps due to excessive salt. We want to know whether using Hartmann’s solution instead of normal saline will prevent this type of acidsosis, and perhaps speed their recovery.

Interventions

Hartmann's solution (compound sodium lactate),given intravenously at a rate to correct dehydration over 48 hours, plus usual maintenance fluid requirement. Dehydration is assumed to be 6% if pH is >7.1 and 10% if pH <7.1. Study fluid will be continued until the patient is not vomiting, is drinking, and for at least 12 hours.

Sponsors

Michael Yung
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

Children admitted to paediatric intensive care or high dependency with diabetic ketoacidosis, including pH<7.3 and/or bicarbonate <15 mmol/l who require intravenous fluid

Exclusion criteria

Glasgow coma score <11 Mechanical ventilation Hyponatraemia: corrected Na <130 mmol/l Potassium >5.5 mmol/l Previous enrolment in the study

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026