Clinical Trials Logo

Clinical Trial Summary

Evaluate effective delivery of goal nutrition with intermittent as compared with continuous enteral nutrition schedules, as defined by percentage of recommended calories that patient receives per day of interest.


Clinical Trial Description

Eligible patients will be approached and if the patient (or surrogate decision maker) is interested, then consent will be obtained for participation in the study. The patient will then be randomly assigned to receive usual care (continuous feeds) or intervention (intermittent feeds, see details below). Randomization will occur via simple block randomization within the REDCap software. Group assignment will not be revealed to the clinical team until the decision to feed the patient has occurred and the actual feeding order is entered. When the clinical team decides to initiate enteral nutrition, they will place a nutrition consult order for tube feed recommendations. Nutrition consult will place recommendations for both continuous feeding and for intermittent schedule, including enteral nutrition formula and dosing. Prior to feeds being started, the patient's randomization status will be revealed to the clinical team. The covering provider will then place the order for enteral nutrition according to the nutritionist's recommendations for the correct feeding schedule. For patients randomized to continuous feeds, their enteral nutrition will be ordered and delivered as per usual care and standard MICU procedure. Nutritionist will provide recommendations for initiation rate, up titration schedule, and maintenance dosing to be delivered continuously over 24 hours. Under usual care of ICU patients, our clinical nutritionists provide a specified formula, a specified calorie goal, and a suggested titration rate. This is typically 20 mL per hour to start with an increase in rate of 20 mL per hour every 6 to 8 hours until the goal rate is achieved. Typical goal rates are in the range of 60 to 80 mL per hour for 24 hours per day. For patients randomized to the intervention group (intermittent feeds), they will receive their enteral nutrition according to a research protocol schedule. This will involve the total recommended feed volume divided into four equal volume "meals." These will be delivered at a rate of 400 cc/hr at 8:00, 12:00, 16:00, and 20:00. The up-titration schedule will be as follows: first meal will be 100 mL, and the volume of each meal thereafter will be increased by 100mL until patient is at goal volume (typically between 300 and 450 mL). There are no formula or diets that are inappropriate to be administered on an intermittent feed schedule. The intervention will not change formula selection or total calorie goals. It will only change the schedule of feeding. For all patients, regardless of feeding schedule, the Kangaroo E-Pump will be used to deliver enteral nutrition, and the above rate and volume parameters can be programmed in. There will be no change in delivery of enteral free water or medications. This schedule will be determined by nursing and clinical care team, as is the current standard of care. To assure correct ordering of intermittent feeds and the insulin prior to each meal, an EPIC orderset with prepopulated instructions will be developed. If there are no signs of or clinical concerns for intolerance, patients will continue to receive enteral nutrition according to assigned schedule until they are extubated or until enteral nutrition is discontinued. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04437264
Study type Interventional
Source Yale University
Contact
Status Enrolling by invitation
Phase N/A
Start date July 7, 2020
Completion date December 2024

See also
  Status Clinical Trial Phase
Completed NCT03438942 - Influence of Iron and Foliate Transporters on Bioavailability of These Micronutrients in the Organism N/A
Recruiting NCT04475666 - Replacing Protein Via Enteral Nutrition in Critically Ill Patients N/A
Recruiting NCT02763878 - Uncut Roux-en-y Anastomosis Reduce Postoperative Complication and Improve Nutritional Status After Distal Gastrectomy Phase 3
Completed NCT02402985 - Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics N/A
Completed NCT02039596 - Nutritional Metabolomics: the Search for Dietary Exposure Variables N/A
Active, not recruiting NCT00996528 - Neighborhood Alcohol & HIV Prevention in South African Townships (Philani) Phase 3
Active, not recruiting NCT04170348 - Daily Vitamin D for Sickle-cell Respiratory Complications Phase 2
Active, not recruiting NCT03843424 - Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers N/A
Recruiting NCT05348590 - Phase-Germ Project: Muscle Mass and Phase Angle in Surgical Patient
Completed NCT03440593 - Indirect Calorimetry Usage and Effect in Ventilator-free Days and Muscle Thickness in Septic Ventilated Patients N/A
Recruiting NCT04554758 - Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation N/A
Recruiting NCT04389424 - Relationship Between Body Composition, Food Consumption, and Micro and Macronutrients With Gene Expression in Breast Cancer
Completed NCT03772171 - Estimate for Dietary Intakes and Hemodialysis Patients
Completed NCT01708681 - Lean Seafood Intake and Postprandial Metabolism N/A
Completed NCT01211301 - Medifast 5 & 1 Plan N/A
Completed NCT01081587 - Preventing Malnutrition and Restoring Nutritional Status in Hospitalized Children N/A
Active, not recruiting NCT03865706 - Inulin for Infections in the Intensive Care Unit Phase 2
Recruiting NCT05276752 - Short- and Long-term Health Adverse Outcomes Associated With Nutrition Disorders and Nutrition Related Conditions in Hospitalized Older People
Recruiting NCT03643341 - Family Healthy Living Early Intervention Program N/A
Not yet recruiting NCT03618329 - Effect of Prehabilitation on the Lean Mass Index (IMM) in ERAS PROGRAMM. N/A