Double Blinded Randomized Control Trial of Types of IVF in Children With DKA
Status:
Suspended
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
Objectives: Intravenous (IV) fluid administration is a fundamental component of diabetic
ketoacidosis (DKA) treatment. Normal saline (NS), the most common IV fluid used in DKA
management, contains more chloride than human blood. Excessive amounts of chloride have been
shown to cause a detrimental metabolic acidosis. Other IV fluids have more physiologic
chloride levels, such as lactated ringers (LR). This study will compare the rates of
hyperchloremic metabolic acidosis in children treated with NS to those treated with LR to
determine the effect on overall length of acidosis and length of stay in the hospital or
intensive care unit.
Design: Single-center, double blinded, randomized controlled trial.
Subjects: Children aged 0 to 18 years who present with diabetic ketoacidosis and require
pediatric intensive care unit admission. Patients with evidence of shock, multi-organ failure
or clinically significant cerebral edema will be excluded. The projected study population
will be 104 patients, 52 in each arm.
Interventions: Patients will be enrolled within 1 hour of presentation to the emergency room
or pediatric intensive care unit if transferred directly from another facility. They will be
randomized to receive intravenous fluids containing 0.9% saline or lactated ringers. All
patients will be treated using the institutional DKA protocol with the content of the
intravenous fluids being the only difference in treatment between arms. Study intervention
lasts until the end of the acute management of DKA.
Planned measurements and study outcomes: The primary study outcome will be duration of
metabolic acidosis. Resolution of metabolic acidosis will be defined in three ways: 1.
Normalization of the ketosis; 2. Normalization of the serum pH; 3. Normalization of the serum
bicarbonate level. Secondary outcomes will include length of stay in the pediatric intensive
care unit and length of stay in the hospital. All outcomes will be correlated with the
overall chloride load given via intravenous fluids during DKA management. Regression
modelling will control for any baseline differences between the groups in regards to severity
of DKA, and if newly diagnosed or poorly controlled diabetes mellitus.