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Early Feeding for Diabetic Ketoacidosis

N/A

Waitlist Available

Led By Kenneth Kenneth, MD

Research Sponsored by Texas Tech University Health Sciences Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Admission to the Medical Intensive Care Unit

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-7 days, may be up to 1-2 weeks.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effects of providing food early on during the treatment of diabetic ketoacidosis (DKA), a serious metabolic disorder commonly seen in intensive care. Currently, it is common practice

Who is the study for?

This trial is for men and women aged 18-89 who are in the Medical Intensive Care Unit, can give informed consent, and have diabetic ketoacidosis (high blood sugar over 250 mg/dL, low arterial pH below 7.3, low serum bicarbonate under 15 mEq/L, with ketones in blood or urine).

What is being tested?

The study is looking at whether eating early on during treatment for diabetic ketoacidosis helps patients recover better compared to not eating at all. It's testing if starting an oral diet sooner has any benefits.

What are the potential side effects?

Since this trial involves the initiation of an oral diet rather than a medication or procedure, side effects may include typical digestive issues but will largely depend on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am admitted to the ICU for serious medical issues.

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I have been diagnosed with diabetic ketoacidosis.

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I am between 18 and 89 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ typically resolution of dka is 24-72 hours, may be up to 5 days in some patients

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~typically resolution of dka is 24-72 hours, may be up to 5 days in some patients

This trial's timeline: 3 weeks for screening, Varies for treatment, and typically resolution of dka is 24-72 hours, may be up to 5 days in some patients for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Length of stay in the medical intensive care unit (in days).

Resolution of DKA

Secondary study objectives

Length of stay in the hospital

mortality

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Early feedingExperimental Treatment1 Intervention

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.

Group II: Nothing per mouthActive Control1 Intervention

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

0 / 3Eligibility criteria met