Diabetes Mellitus Clinical Trial
Official title:
Starvation in the Treatment of Diabetic Ketoacidosis: Is There Enough Evidence to Support This Practice?
Verified date | January 2024 |
Source | Texas Tech University Health Sciences Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 200 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University Medical Center | Lubbock | Texas |
Lead Sponsor | Collaborator |
---|---|
Texas Tech University Health Sciences Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | Length of stay in the medical intensive care unit (in days). | The time from admission order is placed to the time the transfer to another unit order is placed | Days (Typically 3-5 days in the MICU, may be up to 1 week). | |
Secondary | Length of stay in the hospital | from admission order time to the discharge order time | 3-7 days, may be up to 1-2 weeks. | |
Secondary | mortality | If patient passes away within 30 days of participating in the study | 30 day |
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