Double Blinded Randomized Control Trial of Types of IVF in Children With DKA
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|ClinicalTrials.gov Identifier: NCT03066440|
Recruitment Status : Suspended (Shortage of potassium acetate for study intravenous fluids)
First Posted : February 28, 2017
Last Update Posted : October 14, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Diabetic Ketoacidosis||Drug: Normal saline Drug: Lactated Ringers||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||104 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Single-center randomized double-blinded control trial|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Masking Description:||The intravenous fluids administered will all have generic labeling making the study arm assignment unknown to all providers, study personnel and participants. Only the pharmacist filling the orders will known arm assignment.|
|Official Title:||A Single-center Randomized Double Blinded Control Trial of Intravenous Fluid Content in Children With Diabetic Ketoacidosis Admitted to the Pediatric Intensive Care Unit|
|Actual Study Start Date :||September 1, 2018|
|Estimated Primary Completion Date :||April 1, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Placebo Comparator: Normal Saline
Intervention: intravenous solutions containing only normal saline as the primary base during the entire treatment of diabetic ketoacidosis.
Drug: Normal saline
All intravenous fluids used in the treatment of pediatric diabetic ketoacidosis will be based in normal saline for participants in the interventional arm instead of normal saline (as given to participants in the control arm).
Other Name: 0.9 saline
Experimental: Lactated Ringers
Intervention: intravenous solutions containing only lactated ringers as the primary base during the entire treatment of diabetic ketoacidosis.
Drug: Lactated Ringers
All intravenous fluids used in the treatment of pediatric diabetic ketoacidosis will be based in lactated ringer's solution for participants in the interventional arm instead of normal saline (as given to participants in the control arm).
Other Name: Hartmann's Solution
- Length of acidosis [ Time Frame: 28 days ]The time from admission to the emergency room or pediatric intensive care unit to resolution of acidosis (defined as normal pH, serum bicarbonate level >15 and serum ketone level <1)
- Length of stay in the pediatric intensive care unit [ Time Frame: 28 days ]Time from admission to the emergency room or pediatric intensive care unit and transfer from the pediatric intensive care unit to the general pediatric ward
- Length of stay in the hospital [ Time Frame: 28 days ]Time from admission to the emergency room or pediatric intensive care unit and transfer from the pediatric intensive care unit to discharge home
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066440
|United States, New York|
|John R. Oishei Children's Hospital|
|Buffalo, New York, United States, 14203|
|Principal Investigator:||Amanda B Hassinger, MD, MS||SUNY University at Buffalo|