Comparison of the Effects of Intermittent and Continuous Enteral Feeding on Glucose-Insulin Dynamics in Critically Ill Medical Patients
Condition: Glucose-insulin Dynamics
MeSH terms: Critical Illness
Study type: Interventional

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.
    

Intervention name(s): Comparison of the Effects of Intermittent and Continuous Enteral Feeding on Glucose-Insulin Dynamics in Critically Ill Medical Patients; Osmolite 1.2 cal/ml Enteral Feeds
Intervention type(s): Other; Dietary Supplement
Intervention description(s): Placement of feeding tube stomach (oral- or naso-gastric tube)
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.
There will be five blood glucose checks in each data collection period.
If two blood glucose concentrations are above 180 mg/dl then a regular insulin infusion will be initiated.; Osmolite 1.2 cal/ml Enteral Feeds via feeding tube (oral- or naso-gastric tube)
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment