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Clinical Trials/CTRI/2025/10/095923
CTRI/2025/10/095923
Not yet recruiting
Not Applicable

A randomized controlled trial to compare the efficacy and safety of continuous, intermittent and bolus enteral feeding in critically ill patients

Department of Critical Care Medicine1 site in 1 country93 target enrollmentStarted: October 21, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Department of Critical Care Medicine
Enrollment
93
Locations
1
Primary Endpoint
To compare Gastrointestinal intolerance between continuous, intermittent and bolus feeding in critically ill patients.

Overview

Brief Summary

Enteral nutrition (EN) delivers nutrition directly into the gastrointestinal tract and is preferred over parenteral nutrition (PN) due to its physiological benefits, preservation of gut integrity, lower complication risks, and immune advantages. It is widely used in acute, sub-acute, rehabilitation, and long-term care settings, and can be administered as continuous, cyclic, intermittent, or bolus feeding. Intermittent feeding, usually given over 20–60 minutes four to six times daily, is more physiological and allows patient mobility, but carries risks such as aspiration, diarrhea, and gastric distension. Bolus feeding, delivered rapidly via syringe or gravity drip three to six times daily, mimics normal meal patterns and enhances patient independence, though it may increase aspiration risk and cause osmotic diarrhea or delayed gastric emptying with certain formulas.

For critically ill patients, including those intubated, with poor glycemic control, receiving jejunal feeds, or unable to tolerate intermittent schedules, continuous EN via a pump or gravity bag at a set hourly rate is often preferred. Continuous feeding improves tolerance, reduces gastric residuals, and decreases aspiration risk but requires specialized equipment, restricts mobility, and increases costs. Comparative studies suggest continuous feeding offers better tolerance and lower gastric residuals than intermittent or bolus methods, though intermittent and bolus feeding are more physiological. However, no single study has compared all three methods directly, highlighting the need for further research.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients who are on tube feeding with normal gastric function admitted in ICU Who had given informed consent.

Exclusion Criteria

  • Short bowel Severe Acute pancreatitis Post intestinal surgery Intestinal failure High/triple ionotropic support.
  • The patients who died or got discharged before 48 hours of initiation of feeding.

Outcomes

Primary Outcomes

To compare Gastrointestinal intolerance between continuous, intermittent and bolus feeding in critically ill patients.

Time Frame: To compare Gastrointestinal intolerance between continuous, intermittent and bolus feeding in critically ill patients at day1,day2,day3

Secondary Outcomes

  • To compare need for prokinetics, feeding interruption, ICU length of stay, blood glucose control, albumin levels before and after intervention between continuous, intermittent and bolus feeding in critically ill patients.(To compare need for prokinetics, feeding interruption, ICU length of stay, blood glucose control, albumin levels before and after intervention between continuous, intermittent and bolus feeding in critically ill patients at day1, day2, day3)

Investigators

Sponsor
Department of Critical Care Medicine
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Aravind B Guledagudd

Bangalore Medical College and Research Institute

Study Sites (1)

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