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

Primary Purpose

Glucose-insulin Dynamics

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

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

About this trial

This is an interventional treatment trial for Glucose-insulin Dynamics

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Continuous Enteral Feeding

intermittent enteral feeding

Arm Description

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

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

Outcomes

Primary Outcome Measures

Total insulin infused

Secondary Outcome Measures

Mean glucose concentration

Full Information

NCT ID

NCT02853799

First Posted

July 21, 2016

Last Updated

October 17, 2019

Sponsor

San Antonio Military Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02853799

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

August 2016 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

San Antonio Military Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glucose-insulin Dynamics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuous Enteral Feeding

Arm Type

Other

Arm Description

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

Arm Title

intermittent enteral feeding

Arm Type

Other

Arm Description

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

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Osmolite 1.2 cal/ml Enteral Feeds

Intervention Description

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

Primary Outcome Measure Information:

Title

Total insulin infused

Description

Total insulin infused

Time Frame

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

Secondary Outcome Measure Information:

Title

Mean glucose concentration

Description

Mean glucose concentration

Time Frame

time the protocol should be 36 hours to include crossover

Other Pre-specified Outcome Measures:

Title

Glucose standard deviation

Description

Glucose standard deviation

Time Frame

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

Title

Maximum glucose concentration

Description

Maximum glucose concentration

Time Frame

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

Title

Minimum glucose concentration

Description

Minimum glucose concentration

Time Frame

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

Title

Episodes of hypoglycemia

Description

Glucose concentration < 70 mg/dl

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-90 years Anticipated ICU stay greater than 72 hours Expected indication for enteral feeding within first 24-48 hours of ICU admission Exclusion Criteria: 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.

12. IPD Sharing Statement

Available IPD and Supporting Information:

Available IPD/Information Type

Study Protocol

Available IPD/Information URL

http://journals.lww.com/annalsofsurgery/pages/articleviewer.aspx?year=2016&issue=03000&article=00007&type=abstract

Available IPD/Information Comments

2. Chowdhury, Abeed H., et al. "Effects of Bolus and Continuous Nasogastric Feeding on Gastric Emptying, Small Bowel Water Content, Superior Mesenteric Artery Blood Flow, and Plasma Hormone Concentrations in Healthy Adults: A Randomized Crossover Study." Annals of Surgery (2014).

Learn more about this trial

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

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