NCT02853799

Comparison of the Effects of Intermittent and Continuous Enteral Feeding on Glucose-Insulin Dynamics in Critically Ill Medical Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: San Antonio Military Medical Center · Federal
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Continuous enteral feeding is the most common type of nutrition used in critically ill patients despite being non-physiologic, as all mammalian alimentary tracts have been designed for intermittent ingestion of nutrients. The small numbers of randomized controlled studies that have compared intermittent gastric feeds (IGF) to continuous gastric feeds (CGF) in intensive care units have demonstrated that IGF is safe, feasible and have the shorter time to goal nutrition. Studies of healthy adults have also demonstrated that the mean glucose concentration (MGC) is lowered when bolus enteral feedings are used instead of continuous feeds; these changes in glucose-insulin metrics might be beneficial to a critically ill patient population where stress hyperglycemia is common. This study will compare the effects of CGF and IGF in a critically ill medical patient population. Glucose-insulin dynamics for each type of enteral feed will be analyzed by performing a randomized crossover study to compare the effects of CGF and IGF on MGC, total insulin infused, glucose variability (GV), episodes of hypoglycemia and maximum glucose concentration values.

Detailed description

This will be a non-blinded randomized crossover study in a generalized population of critically ill adults. The population of this study is defined from the ages of 18-90 admitted to the Medical Intensive Care Unit (MICU). This study will compare the glucose-insulin dynamics in critically ill adults that are feed using either a CGF or IGF scheme while their glucose concentrations are maintained between 140-180 mg/dl using an insulin infusion protocol. Randomization performed using computer generated random numbers kept individually in sealed envelopes. All participants will have nasal gastric or oral gastric (NG/OG) tube previously placed for their nutritional needs. The amount of Osmolite given will be determined by the ideal weight for each participant: 1.2 cal/ml Osmolite with caloric goal of 25 kcal/kg/day. Feeding intolerance develops which is defined as: excessive abdominal distention, emesis, abdominal pain, vomiting and gastric residual \> 250 ml for IGF and gastric residual \> 500 ml for CGF.

Conditions

• Glucose-insulin Dynamics

Interventions

Type	Name	Description
OTHER	Comparison of the Effects of Intermittent and Continuous Enteral Feeding on Glucose-Insulin Dynamics in Critically Ill Medical Patients	1. Placement of feeding tube stomach (oral- or naso-gastric tube) 2. Randomized to receive either continuous feeding or intermittent feeding first. Once at goal nutrition for 4 hours, enter first 4-hour data collection interval. Next proceed with cross-over and complete a 4-hour washout period with the feed type. Finally enter second 4-hour data collection period. To enter into the first data collection period, the patient would require an insulin infusion. 3. There will be five blood glucose checks in each data collection period. 4. If two blood glucose concentrations are above 180 mg/dl then a regular insulin infusion will be initiated.
DIETARY_SUPPLEMENT	Osmolite 1.2 cal/ml Enteral Feeds	Osmolite 1.2 cal/ml Enteral Feeds via feeding tube (oral- or naso-gastric tube)

Timeline

• Start date: 2016-08-01
• Primary completion: 2017-08-01
• Completion: 2017-10-01
• First posted: 2016-08-03
• Last updated: 2019-10-21