Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Diabetic ketoacidosis (DKA) and hyperosmolar hyperglycemic state (HHS) are common, but serious metabolic disorders are often encountered in intensive care. In the intensive care setting, it is common to withhold food from patients during treatment of DKA. However, there is no evidence or current literature supporting this practice. The following proposed research investigates the initiation of an early diet versus withholding food during the treatment of diabetic ketoacidosis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early feeding | Experimental | If randomized to the experimental group, patient's diet will be advanced to clear liquid for the first day. On the second day, diet will be advanced to full liquid and advanced up to oral (carb controlled 1600 calories) diet as tolerated. |
|
| Nothing per mouth | No Intervention | Patient will be kept without PO intake until they are bridged from the insulin drip |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early feeding with an oral diet | Other | Participants in the treatment arm will be initiated on a clear liquid diet on day 1 of medical ICU admission. Diet will be progressed on day 2 to full liquid diet or diabetic diet as patient tolerates based on which diet the patient would prefer. |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of DKA | Defined as a closed anion gap. Adjusted Anion Gap defined as (Blood Sodium - Blood Chloride - Blood Bicarbonate) + 0.25 x ((normal albumin (4.0)) x (observed albumin)); Elevated Anion Gap is >12 | Typically resolution of DKA is 24-72 hours, may be up to 5 days in some patients |
| Length of stay in the medical intensive care unit (in days). | The time from admission order is placed to the time the transfer to another unit order is placed | Days (Typically 3-5 days in the MICU, may be up to 1 week). |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay in the hospital | from admission order time to the discharge order time | 3-7 days, may be up to 1-2 weeks. |
| mortality | If patient passes away within 30 days of participating in the study |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenneth Kenneth, MD | Texas Tech University Health Sciences Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center | Lubbock | Texas | 79415 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 1, 2023 | Nov 13, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 16, 2023 | Nov 13, 2023 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D016883 | Diabetic Ketoacidosis |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 30 day |
| D007662 | Ketosis |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D048909 | Diabetes Complications |