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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06186245
Other study ID # TTUHSCDKA
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date December 27, 2023
Est. completion date December 2024

Study information

Verified date January 2024
Source Texas Tech University Health Sciences Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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.

Study Design


Intervention

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.

Locations

Country Name City State
United States University Medical Center Lubbock Texas

Sponsors (1)

Lead Sponsor Collaborator
Texas Tech University Health Sciences Center

Country where clinical trial is conducted

United States, 

Outcome

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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