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

NCT02853799 | Completed

• 1 other identifier: x5tjqsc6
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Glucose-insulin Dynamics

Outcome Measures

Primary Outcomes (1)

• Total insulin infused

  Total insulin infused

  total time in the protocol should be 36 hours to include crossover

Secondary Outcomes (1)

• Mean glucose concentration

  time the protocol should be 36 hours to include crossover

Other Outcomes (4)

• Glucose standard deviation

  total time in the protocol should be 36 hours to include crossover

• Maximum glucose concentration

  total time in the protocol should be 36 hours to include crossover

• Minimum glucose concentration

  total time in the protocol should be 36 hours to include crossover

Study Arms (2)

Continuous Enteral Feeding

OTHER

Crossover Study: Randomized to continuous enteral feeding first then crossed over to receive versus intermittent enteral feeding next.

Other: Comparison of the Effects of Intermittent and Continuous Enteral Feeding on Glucose-Insulin Dynamics in Critically Ill Medical Patients; Dietary Supplement: Osmolite 1.2 cal/ml Enteral Feeds

intermittent enteral feeding

OTHER

Crossover Study: Randomized to intermittent enteral feeding first then crossed over to receive versus continuous enteral feeding next.

Other: Comparison of the Effects of Intermittent and Continuous Enteral Feeding on Glucose-Insulin Dynamics in Critically Ill Medical Patients; Dietary Supplement: Osmolite 1.2 cal/ml Enteral Feeds

Interventions

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

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.

Continuous Enteral Feeding; intermittent enteral feeding

Osmolite 1.2 cal/ml Enteral Feeds DIETARY_SUPPLEMENT

Osmolite 1.2 cal/ml Enteral Feeds via feeding tube (oral- or naso-gastric tube)

Continuous Enteral Feeding; intermittent enteral feeding

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-90 years
• Anticipated ICU stay greater than 72 hours
• Expected indication for enteral feeding within first 24-48 hours of ICU admission

You may not qualify if:

• Any contraindications relating to an oral or nasal gastric tube, Osmolite 1.2 cal/ml, goal rate (or goal volume) of Osmolite 1.2 cal/ml using a 24-hour goal nutrition, gastric feeds due to anatomical/physiological pathology, ideal body weight that exceeds 85 kg to maintain goal volumes in the intermittent arm below 301 ml or a potassium greater than 6.4.
• Planned procedures or tests that would require holding gastric feeds during the protocol.
• Pregnancy, confirmed by pregnancy test on all females \< 60 years of age.
• Hemodynamic instability as defined by any vasoactive medication requirement for blood pressure support or cardiac arrhythmias to include: Norepinephrine ≥ 5 mcg/min, Epinephrine ≥ 5 mcg/min, Dopamine \> 5 mcg/kg/min, Milrinone 0.375mcg/kg/min, Vasopressin \> 0.04 Units/min, Dobutamine \> 5 mcg/kg/min, any other vasoactive drip, and any combination of low dose vasopressors listed above. Atrial Nodal blocking agents used in a continuous drip form to include diltiazem, esmolol and amiodarone are allowed if not requiring the above vasoactive medications restrictions.
• Prior surgical procedure that would preclude a goal rate/or volume for CGF/IGF to include: previous partial or complete gastrectomy or massive intestinal resection leaving less than 200 cm of small bowel.
• Screening glucose concentration less than 120 mg/dl while NPO unless diabetic.

Sponsors & Collaborators

• San Antonio Military Medical Center: lead

MeSH Terms

Interventions

Osmolite; Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pulmonary/Critical Care Fellow

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: August 3, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 21, 2019

Record last verified: 2019-10