Starvation in the Treatment of Diabetic Ketoacidosis

Not Applicable

• Conditions: Diabetes Mellitus; Diabetic Ketoacidosis
• Interventions: Other: Early feeding with an oral diet

• Registration Number: NCT06186245
• Lead Sponsor: Texas Tech University Health Sciences Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-14
• Study First Submitted QC: 2023-12-15
• Study Start: 2023-12-27
• Study First Posted: 2023-12-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-05
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early feeding	Early feeding with an oral diet	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University Medical Center; 🇺🇸 Lubbock, Texas, United States