Diabetes Mellitus, Diabetic Ketoacidosis
Conditions
Brief summary
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.
Interventions
OTHEREarly feeding with an oral diet
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.
Sponsors
Texas Tech University Health Sciences Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of DKA | Typically resolution of DKA is 24-72 hours, may be up to 5 days in some patients | 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 |
| 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). | The time from admission order is placed to the time the transfer to another unit order is placed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay in the hospital | 3-7 days, may be up to 1-2 weeks. | from admission order time to the discharge order time |
| mortality | 30 day | If patient passes away within 30 days of participating in the study |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKenneth Kenneth, MD
Texas Tech University Health Sciences Center
Outcome results
None listed