Starvation in the Treatment of Diabetic Ketoacidosis

Texas Tech University Health Sciences Center

Status: Invitation-only

Conditions: Diabetic Ketoacidosis; Diabetes Mellitus

Treatments: Other: Early feeding with an oral diet

Study type: Interventional

Funder types: Other

Identifiers

NCT06186245

TTUHSCDKA

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Early feeding

Experimental group

Description:

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.

Treatment:

Other: Early feeding with an oral diet

Nothing per mouth

No Intervention group

Description:

Patient will be kept without PO intake until they are bridged from the insulin drip