Preoperative Fasting vs. Not Fasting in Critically Ill Patients
FEEDS
FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway
2 other identifiers
interventional
1,072
1 country
19
Brief Summary
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. '
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Typical duration for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 20, 2024
CompletedFirst Posted
Study publicly available on registry
December 27, 2024
CompletedStudy Start
First participant enrolled
April 28, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
January 30, 2026
January 1, 2026
2.8 years
December 20, 2024
January 28, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (22)
Postoperative mortality
Post-operative day 28
Ventilator-free days in survivors
Post-operative day 28
All-cause, all-location mortality
Post-operative day 90
Length of ICU stay
Post-operative day 90
Length of hospital stay
Post-operative day 90
- +17 more secondary outcomes
Study Arms (2)
Fasting
ACTIVE COMPARATORPatients randomized to the Fasting arm will have tube feeding stopped at least 8 hours before the scheduled surgery or procedure time.
Not Fasting
ACTIVE COMPARATORPatients randomized to the Not Fasting arm will have tube feeding continued until transfer to the operating room/procedure area.
Interventions
Process: Fasting pre-procedure Tube feeding will be stopped at least 8 hours before the patient's scheduled surgery or procedure time.
Process: Not fasting pre-procedure Tube feeding will be continued until patient transfer to the operating room/procedure area.
Eligibility Criteria
You may qualify if:
- \. Age ≥ 18
- Current admission to ICU\*
- Secure airway\*\* with no plans for its removal prior to procedure
- Current non-trophic (\> 10 mL/hr) tube (enteral) feeding\*\*\* with no plans to discontinue prior to procedure for reasons other than preoperative fasting
- 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
You may not qualify if:
- Inability to obtain informed consent
- Inability to enroll and randomize \> 8 hours prior to planned procedure time
- Inability to deliver trial interventions
- Expected survival \< 48 hours as determined by the enrolling physician-investigator
- Critically ill burn patient
- Emergency procedure
- a. Gastrointestinal tract procedure that requires fasting based on surgical indications or b. airway/lung procedure that requires removal of endotracheal or tracheostomy tube
- Plan for prone or Trendelenburg (head down) positioning during most of the procedure
- 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)
- Plan for postoperative extubation in the procedure area
- Prisoner
- 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
- Refusal to enroll patient by treating physician
- 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.
- Chronic mechanical ventilation at pre-admission level of care
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- Columbia Universitycollaborator
- Patient-Centered Outcomes Research Institutecollaborator
Study Sites (19)
Stanford Medical Center
Palo Alto, California, 94305, United States
UCSF Medical Center Parnassus
San Francisco, California, 94143, United States
University of Colorado Medical Center
Aurora, Colorado, 80045, United States
University of Miami Hospital
Miami, Florida, 33136, United States
McGaw Medical Center of Northwestern
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Mass General Hospital
Boston, Massachusetts, 02114, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
Columbia University Irvine Medical Center
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27103, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
UT Health Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Nagrebetsky, MD, MSC
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthesia Attending
Study Record Dates
First Submitted
December 20, 2024
First Posted
December 27, 2024
Study Start
April 28, 2025
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
January 30, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- 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.
- 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.
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.