Preoperative Fasting vs. Not Fasting in Critically Ill Patients (FEEDS)

FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway

The goal of this clinical trial is to learn if fasting or not fasting before a procedure has an effect on recovery in those who are critically ill. The main questions it aims to answer for patients on a breathing machine who are receiving tube feeding are:

• Does the risk of lung complications and death differ between those who are not fasting, which may have a higher chance of allowing tube feeding to enter the lungs, and fasting, which temporarily stops nutrition before a procedure?
• Is there a difference in recovery times, hospital stays, infection rates, need for organ support, safety, and nutrition for those who either fast or do not fast before a procedure?
• What is the relationship between nutrition and clinical outcomes?

Researchers will compare not fasting and fasting to see if it has an effect on recovery.

Participants will:

• Be assigned by chance (like a coin toss) to one of two groups. One group (fasting group) will have their tube feeding stopped at least 8 hours before their procedure. The other group (not fasting group) will have their tube feeding stopped right before their procedure.
• Be monitored via medical record for amount of protein and calories received, and any complications related to fasting/not fasting.
• Receive a phone call from the study team about 3 months after they enter the study to see how they are doing and complete a questionnaire.

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Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Pulmonary Aspiration; Fasting; Surgical Procedure, Unspecified
• Intervention / Treatment: Other: Fasting; Other: Not fasting

Detailed Description

Patient Population: Critically ill patients in the ICU who are: mechanically ventilated, receiving tube feeding (enteral nutrition), with a planned surgery or procedure. Up to 1072 subjects will be enrolled.

Phase III pragmatic multicenter parallel-group randomized controlled non-inferiority trial with patient-level randomization and assessor blinding.

Enrollment Period: Approximately two years.

Aims:

• Aim 1: To compare the risk of pulmonary complications and mortality from: (1) perioperative pulmonary aspiration6,33,34 due to not fasting vs. (2) systemic effects of nutritional loss18-24 due to preoperative fasting. We will quantify the risk of pulmonary complications and mortality as the number of postoperative days alive and free from mechanical ventilation (DAFV)35,36 in the target population of critically ill patients with a secure airway who undergo interventional procedures.
• Aim 2: To compare length of ICU and hospital stay, discharge to home, need for organ support, infectious complications, safety outcomes, and nutritional outcomes in tube-fed mechanically ventilated patients with a secure airway who are fasted vs. not fasted prior to procedure.
• Aim 3: To define the relationship between perioperative fasting duration, calorie/protein delivery, and clinical outcomes in mechanically ventilated patients who receive tube feeding.

Study participants will be randomized with a 1:1 allocation ratio to one of the following preprocedural interventions:

1. Fasting - stopping tube feeding at least 8 hours prior to the scheduled procedure time;
2. Not fasting - tube feeding until call for transfer to the procedure area.

• Study Type: Interventional
• Enrollment (Estimated): 1072
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexander Nagrebetsky, MD, MSc; Phone Number: 617-724-3292; Email: anagrebetsky@mgh.harvard.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Recruiting
      • Stanford Medical Center
      • Contact: Pedro Tanaka, MD, PhD, MACM; Phone Number: (650) 498-6000; Email: ptanaka@stanford.edu
    • San Francisco, California, United States, 94143
      • Recruiting
      • UCSF Medical Center Parnassus
      • Contact: Lee-lynn Chen, MD; Phone Number: (415) 567-6600; Email: Lee-lynn.Chen@ucsf.edu
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
      • University of Colorado Medical Center
      • Contact: Ana Fernandez-Bustamante, MD, PhD, FASA; Phone Number: 720-848-0000
  • Florida
    • Miami, Florida, United States, 33136
      • Not yet recruiting
      • University of Miami Hospital
      • Contact: Alexander Fort III, MD; Phone Number: 305-243-4000; Email: acfort@med.miami.edu
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Contact: Alisha Sachdev, MD; Phone Number: (888) 352-7874; Email: Alisha_Sachdev@rush.edu
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • McGaw Medical Center of Northwestern
      • Contact: Ravindra Gupta, MD, FASA, FCCP; Phone Number: (312) 503-7975; Email: Ravindra.Gupta@nm.org
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Not yet recruiting
      • University of Maryland Medical Center
      • Contact: Megan Anders, MD; Phone Number: (410) 328-8600; Email: manders@som.umaryland.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham & Women's Hospital
      • Contact: Gyorgy Frendl
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Mass General Hospital
      • Contact: Alex Nagrebetsky
    • Worcester, Massachusetts, United States, 01655
      • Recruiting
      • University of Massachusetts Memorial Medical Center
      • Contact: Guido Musch, MD, MBA; Phone Number: (508) 334-1000; Email: Guido.Musch@umassmed.edu
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota Medical Center
      • Contact: Benjamin Keith, MD; Phone Number: 855-324-7843; Email: keith200@umn.edu
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: David Amar, MD; Phone Number: 212-639-2000; Email: amard@mskcc.org
    • New York, New York, United States, 10032
      • Recruiting
      • Columbia University Irvine Medical Center
      • Contact: Vivek Moitra, MD, FASA, FCCP; Phone Number: (212) 305-2500; Email: vm2161@cumc.columbia.edu
    • Rochester, New York, United States, 14642
      • Not yet recruiting
      • University of Rochester Medical Center
      • Contact: Jacob Nadler, MD, PhD, FASA; Phone Number: (585) 275-2100; Email: Jacob_Nadler@URMC.Rochester.edu
    • The Bronx, New York, United States, 10467
      • Recruiting
      • Montefiore Medical Center
      • Contact: Michael Kiyatkin, MD; Phone Number: 718-920-4321; Email: mkiyatkin@montefiore.org
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Ashish Khanna, MD, FCCP, FCCM; Phone Number: 336-758-5000; Email: akhanna@wakehealth.edu
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Active, not recruiting
      • Cleveland Clinic
  • Texas
    • Galveston, Texas, United States, 77555
      • Recruiting
      • University of Texas Medical Branch
      • Contact: Marcos Vidal Melo, MD, PhD; Phone Number: 409-772-1011; Email: mfvidalm@UTMB.EDU
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • UT Health Houston
      • Contact: Turan Mehmet, MD; Phone Number: 713-486-1000; Email: mehmet.a.turan@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 1. Age ≥ 18
2. Current admission to ICU*
3. Secure airway** with no plans for its removal prior to procedure
4. Current non-trophic (> 10 mL/hr) tube (enteral) feeding*** with no plans to discontinue prior to procedure for reasons other than preoperative fasting

5. Planned eligible procedure (Examples are listed in Appendix C) with anesthesia care or nursing sedation. Eligible procedures are defined as non-emergent diagnostic or therapeutic interventions that:

   • Do NOT have a well-established practice of preoperative fasting. (For example, bedside placement of a vascular catheter [arterial, central venous, peripheral venous] by the ICU team is NOT eligible for this trial since it has a widely established practice of no preoperative fasting and is not generally scheduled for a specific time.)
   • Do NOT require fasting for preoperative gastrointestinal tract preparation
   • Do NOT require removal/replacement of the endotracheal or tracheostomy tube
   • Do NOT require prone or Trendelenburg (head-down) positioning.
   • Typically require procedural sedation or anesthesia care.
   • Generally, are scheduled for a specific time (although this time can change, or procedure may be cancelled).

   • Are performed in the operating room, non-operating room procedural areas, or at the patient's bedside.

     • All ICU types are eligible: surgical, medical, cardiac, neurological, trauma, mixed etc.

       • Secure airway is defined as a cuffed endotracheal tube or a cuffed tracheostomy tube.

         • Patients with all types of feeding tubes are eligible, regardless of tube insertion site (nasal, oral, surgically implanted) and tube tip location (pre- and post-pyloric) †As determined by the enrolling physician-investigator

Exclusion Criteria

1. Inability to obtain informed consent
2. Inability to enroll and randomize > 8 hours prior to planned procedure time
3. Inability to deliver trial interventions
4. Expected survival < 48 hours as determined by the enrolling physician-investigator
5. Critically ill burn patient
6. Emergency procedure
7. a. Gastrointestinal tract procedure that requires fasting based on surgical indications or b. airway/lung procedure that requires removal of endotracheal or tracheostomy tube
8. Plan for prone or Trendelenburg (head down) positioning during most of the procedure
9. Major impairment of gastrointestinal motility or major structural disease of the gastrointestinal tract (e.g., severe gastroparesis, bowel obstruction, severe ileus, severely compromised lower esophageal sphincter, active gastrointestinal bleeding)
10. Plan for postoperative extubation in the procedure area
11. Prisoner
12. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test during the current hospitalization, or woman who is breast feeding
13. Refusal to enroll patient by treating physician
14. Extracorporeal Membrane Oxygenation (ECMO) at the time of potential enrollment, except patients scheduled for ECMO decannulation as the study procedure and patients expected to be off of ECMO at the time of study procedure.
15. Chronic mechanical ventilation at pre-admission level of care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fasting; Patients randomized to the Fasting arm will have tube feeding stopped at least 8 hours before the scheduled surgery or procedure time.	Other: Fasting; Process: Fasting pre-procedure Tube feeding will be stopped at least 8 hours before the patient's scheduled surgery or procedure time.
Active Comparator: Not Fasting; Patients randomized to the Not Fasting arm will have tube feeding continued until transfer to the operating room/procedure area.	Other: Not fasting; Process: Not fasting pre-procedure Tube feeding will be continued until patient transfer to the operating room/procedure area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days alive and free from mechanical ventilation on postoperative day 28.	Defined as the days alive and free of organ support (dialysis, assisted ventilation, and vasopressors) to day 28. Participants will need to be free of all three components (assisted ventilation, vasopressors, new renal replacement therapy) to qualify for a day alive and free from organ failures. Patients on chronic dialysis will not be scored for the new renal failure free component of this outcome.	Post-operative day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative mortality	Death from any cause at any location, including deaths after withdrawal of care.	Post-operative day 28
Ventilator-free days in survivors	28 minus last post-operative day of mechanical ventilation assessed only in survivors at post-operative day 28. Non-survivors are excluded	Post-operative day 28
All-cause, all-location mortality	Death from any cause at any location, including deaths after withdrawal of care.	Post-operative day 90
Length of ICU stay	90 minus the last post-operative day of ICU admission.	Post-operative day 90
Length of hospital stay	90 minus the last post-operative day of hospital/facility admission.	Post-operative day 90
Days alive and without life support54 Days alive and without life support	90 minus the last post-operative day of mechanical ventilation, renal replacement therapy, or circulatory support (ECMO, vasopressor or inotrope), whichever is used last.	Post-operative day 90
Proportion of patients alive and at home	Proportion of patients who are alive and at home or at pre-index hospitalization level of care.	Post-operative day 90
Health-related quality of life	Short-Form 20	Post-operative day 90
New surgical site infection	Documentation of superficial incisional or organ/space infection after index procedure in routine medical records	Post-operative day 90
New bacteremia	Bacteremia in patients without pre-study intervention evidence of bacteremia during the same hospital admission.	Post-operative day 90
Perioperative pulmonary aspiration	Periprocedural pulmonary aspiration of gastric contents documented in routine medical records.	Time of procedure start +/- 24 hours
Perioperative Hyperglycemia	Routinely collected blood glucose of > 180 mg/dL on at least one measurement.	Time of procedure start +/- 24 hours
Perioperative hypoglycemia	At least one episode of routinely collected blood glucose of 41 to 70 mg/dL (moderate hypoglycemia) or ≤ 40 mg/dL (severe hypoglycemia).	Time of procedure start +/- 24 hours
Preoperative fasting duration	Time from last routinely documented non-trophic (> 10 mL/hr) tube feeding to procedure start.	Time of procedure start - 72 hours
Postoperative fasting duration	Time from procedure end to the first routinely documented non-trophic (>10 mL/hr) tube feeding volume/rate.	Time of procedure start + 72 hours
Perioperative fasting duration	Duration of preoperative plus postoperative fasting.	Time of procedure start +/- 72 hours
Preoperative calories delivered	Total number of calories delivered via tube feeding within 24 and 72 hours prior to procedure.	Time of procedure - 72 and -24 hours
Postoperative calories delivered	Total number of calories delivered via tube feeding within 24 and 72 hours after the procedure.	Time of procedure + 72 and + 24 hours
Perioperative calories delivered	Total number of calories delivered via tube feeding within 24 and 72 hours of the procedure.	Time of procedure +/- 72 and +/- 24 hours
Preoperative protein delivered	Total amount of protein delivered via tube feeding within 24 and 72 hours prior to procedure.	Time of procedure - 72 and -24 hours
Postoperative protein delivered	Total amount of protein delivered via tube feeding within 24 and 72 hours after the procedure.	Time of procedure + 72 and + 24 hours
Perioperative protein delivered	Total amount of protein delivered via tube feeding within 24 and 72 hours of the procedure	Time of procedure +/- 72 and +/- 24 hours

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Patient-Centered Outcomes Research Institute; Columbia University
• Investigators: Principal Investigator: Alexander Nagrebetsky, MD, MSC, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: December 20, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: enteral nutrition; preoperative fasting; perioperative medicine; pulmonary aspiration; tube feeding; surgery in critically ill; procedures in critically ill; nutrition in critical illness; perioperative safety; preoperative management; preoperative fasting in secure airway; anesthesia in critically ill
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Behavior; Feeding Behavior; Critical Illness; Fasting; Angptl4 protein, mouse
• Other Study ID Numbers: 2024P003035; BPS-2023C1-31273 (Other Grant/Funding Number: PCORI - Patient-Centered Outcomes Research Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study sites of this trial will share deidentified data through eCRF with the Statistical and Data Coordinating Center. The shared data will include patient baseline characteristics (clinical and demographic), data on trial interventions, and outcome data.
• IPD Sharing Time Frame: Upon completion of the study, the final cleaned and locked data set will be deidentified per the HIPAA Privacy Rule (45 C.F.R. § 164.514(b)). The deidentified Full Data Package will be deposited in the Patient-Centered Outcomes Data Repository (PCODR) at the Inter-university Consortium for Political and Social Research (ICPSR) at the University of Michigan.
• IPD Sharing Access Criteria: Access to the data will be based on the regulations of the Patient-Centered Outcomes Data Repository (PCODR) at the Inter-university Consortium for Political and Social Research (ICPSR) at the University of Michigan.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No