About this trial

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.

* Data from routine electronic medical records will be reviewed to determine how participants are doing 3 months after their procedure.

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Eligibility criteria

Qualifiers

1. 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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fasting
  • Not fasting

Treatment groups

1,072 Participants
are divided into 2 treatment groups

Locations

19
California
Stanford Medical Center94305, Palo Alto United States
UCSF Medical Center Parnassus94143, San Francisco United States
Colorado
University of Colorado Medical Center80045, Aurora United States
Florida
University of Miami Hospital33136, Miami United States

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Columbia University

Collaborator