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RECRUITING
NCT06751043
NA

Preoperative Fasting vs. Not Fasting in Critically Ill Patients

Sponsor: Massachusetts General Hospital

View on ClinicalTrials.gov

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. '

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1072

Start Date

2025-04-28

Completion Date

2028-05

Last Updated

2026-01-30

Healthy Volunteers

No

Interventions

OTHER

Fasting

Process: Fasting pre-procedure Tube feeding will be stopped at least 8 hours before the patient's scheduled surgery or procedure time.

OTHER

Not fasting

Process: Not fasting pre-procedure Tube feeding will be continued until patient transfer to the operating room/procedure area.

Locations (19)

Stanford Medical Center

Palo Alto, California, United States

UCSF Medical Center Parnassus

San Francisco, California, United States

University of Colorado Medical Center

Aurora, Colorado, United States

University of Miami Hospital

Miami, Florida, United States

McGaw Medical Center of Northwestern

Chicago, Illinois, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Mass General Hospital

Boston, Massachusetts, United States

Brigham & Women's Hospital

Boston, Massachusetts, United States

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, United States

University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Columbia University Irvine Medical Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Cleveland Clinic

Cleveland, Ohio, United States

University of Texas Medical Branch

Galveston, Texas, United States

UT Health Houston

Houston, Texas, United States