Starvation in the Treatment of Diabetic Ketoacidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Early feeding with an oral diet.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus, Diabetic Ketoacidosis. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Starvation in the Treatment of Diabetic Ketoacidosis: Is There Enough Evidence to Support This Practice?
Overview
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
- Other Early 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.
Primary outcome measures
- Resolution of DKA [Time frame: 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). [Time frame: Days (Typically 3-5 days in the MICU, may be up to 1 week).]
Secondary outcome measures (2)
- Length of stay in the hospital [Time frame: 3-7 days, may be up to 1-2 weeks.]
- mortality [Time frame: 30 day]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University Medical Center — Lubbock
Identifiers
NCT: NCT06186245 · TTUHSCDKA