Starvation in the Treatment of Diabetic Ketoacidosis

Study Overview
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Brief Summary
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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.

Official Title
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Starvation in the Treatment of Diabetic Ketoacidosis: Is There Enough Evidence to Support This Practice?

Conditions
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Diabetes Mellitus, Diabetic Ketoacidosis

Intervention / Treatment
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* Other: Early feeding with an oral diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females with the diagnosis of diabetic ketoacidosis (defined as blood glucose greater than 250 mg/dL, arterial pH less than 7.3, serum bicarbonate less than 15 mEq/L, and the presence of ketonemia or ketonuria) Age between 18-89 Admission to the Medical Intensive Care Unit Able to provide informed consent Exclusion Criteria: Pregnant and breast-feeding women Institutionalized patients or prisoners Patients unable to eat by mouth, including intubation, presence of any tube used for enteral feeding (nasogastric tube, orogastric tube, PEG tube, etc.), medical conditions requiring parenteral feeding, and a history of a medical condition that prevented oral intake prior to admission, including achalasia, esophageal cancer, stroke with residual deficits preventing oral intake, amyotrophic lateral sclerosis, or head and neck trauma.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early feeding<br> | Other: Early feeding with an oral diet<br>* 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.<br>|
| No Intervention: Nothing per mouth<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). |  | Days (Typically 3-5 days in the MICU, may be up to 1 week). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in the hospital |  | 3-7 days, may be up to 1-2 weeks. | 
| mortality |  | 30 day |