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Randomized trial to determine if the volume of fluid administration in pediatric patients with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of treatment
A randomized trial of two initial volumes of IVF and subsequent administration rates. Group I received 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance and Group II received 20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance. The specific variables measured included demographics (age, gender, and race/ethnicity) and routine laboratory values (pH, pCO2, plasma glucose, electrolytes, bicarbonate, sodium, chloride, BUN. Length of treatment was defined as a time of the hospital stay after the start of IVF infusion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| slow fluid rate | Active Comparator | bolus 10 ml/kg of NS followed by 1.25 times maintenance rate |
|
| Fast fluid rate | Active Comparator | bolus 20 ml/kg of NS followed by 1.5 times maintenance rate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| slow fluid rate | Other | 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to normalization of bicarbonate and pH | Laboratory parameters were measured hourly for the first 4 hours, and every 2 to3 hours thereafter until acid-base normalization (pH was above 7.3 or the HCO3 was above 15 mmol/L) | start of treatment until resolution of DKA an expected average of 12 to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| the length of treatment | Length of treatment was defined as a time of the hospital stay after the start of IVF infusion | discharge from the hospital, an expected average of 1-2 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arleta Rewers, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Childrens Hospital Colorado | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26823137 | Derived | Bakes K, Haukoos JS, Deakyne SJ, Hopkins E, Easter J, McFann K, Brent A, Rewers A. Effect of Volume of Fluid Resuscitation on Metabolic Normalization in Children Presenting in Diabetic Ketoacidosis: A Randomized Controlled Trial. J Emerg Med. 2016 Apr;50(4):551-9. doi: 10.1016/j.jemermed.2015.12.003. Epub 2016 Jan 25. |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| fast fluid rate | Other | 20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance |
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