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The purpose of this study is to determine the effects of the addition of insulin glargine during the early phase of moderate to severe Diabetic Ketoacidosis (DKA) in children.
The investigators hypothesize that the addition of insulin glargine during the early phase of management of DKA will accelerate acidosis correction, decrease the length of insulin infusion, and decrease the total intensive care unit time in children admitted to the ICU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glargine | Experimental | 0.3u/kg of glargine, subcutaneously, once |
|
| Placebo | Placebo Comparator | 0.3u/kg of saline, subcutaneously, once |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| glargine | Drug | 0.3u/kg of glargine, subcutaneously, once |
| |
| saline |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Acidosis Correction | Unable to find any data on this study. PI left Vanderbilt and there was not a publication. | Minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Time on Insulin Drip | Unable to find any data on this study. PI left Vanderbilt and there was not a publication. | Minutes |
| Total Hospital Stay | Unable to find any data on this study. PI left Vanderbilt and there was not a publication. |
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Inclusion Criteria:
AND:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sheila McMorrow, MD | Vanderbilt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Monroe Carell Children's Hospital | Nashville | Tennessee | 37232 | United States |
Original data cannot be found. PI has left Vanderbilt and does not know where records are located. Total enrollment and completion date was obtained from Institutional Review Board records.
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| ID | Title | Description |
|---|---|---|
| FG000 | Glarine | glargine: 0.3u/kg of glargine, subq, once |
| FG001 | Placebo | saline: 0.3cc/kg of saline, subq, once |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Glargine | 0.3u/kg of glargine, subcutaneously, once glargine: 0.3u/kg of glargine, subcutaneously, once |
| BG001 | Placebo | 0.3u/kg of saline, subcutaneously, once saline: 0.3u/kg of saline, subcutaneously, once |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time of Acidosis Correction | Unable to find any data on this study. PI left Vanderbilt and there was not a publication. | Posted | Minutes |
|
|
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Unable to find any data on this study. PI left Vanderbilt and there was not a publication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Glarine | glargine: 0.3u/kg of glargine, subq, once | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sheila McMorrow | Vanderbilt University Medical Center | 615-343-8332 |
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| ID | Term |
|---|---|
| D016883 | Diabetic Ketoacidosis |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Drug |
0.3u/kg of saline, subcutaneously, once |
|
| Days |
| BG002 | Total | Total of all reporting groups |
|
| Age, Continuous |
| Sex: Female, Male |
|
| Region of Enrollment | participants |
|
| Secondary | Time on Insulin Drip | Unable to find any data on this study. PI left Vanderbilt and there was not a publication. | Posted | Minutes |
|
|
| Secondary | Total Hospital Stay | Unable to find any data on this study. PI left Vanderbilt and there was not a publication. | Posted | Days |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | saline: 0.3cc/kg of saline, subq, once | 0 | 0 | 0 | 0 | 0 | 0 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D048909 | Diabetes Complications |
| D004700 | Endocrine System Diseases |
| D044882 | Glucose Metabolism Disorders |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |