Preoperative Fasting vs. Not Fasting in Critically Ill Patients (NCT06751043)
🩺 Plain-English Summary (8th-Grade Level)
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. '
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (15 items) and avoid the listed exclusions (16 items).
Location: Stanford Medical Center — Palo Alto, California
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (19 Sites)
- Stanford Medical Center — Palo Alto, California
- UCSF Medical Center Parnassus — San Francisco, California
- University of Colorado Medical Center — Aurora, Colorado
- University of Miami Hospital — Miami, Florida
- McGaw Medical Center of Northwestern — Chicago, Illinois
- Rush University Medical Center — Chicago, Illinois
- University of Maryland Medical Center — Baltimore, Maryland
- Mass General Hospital — Boston, Massachusetts
- Brigham & Women's Hospital — Boston, Massachusetts
- University of Massachusetts Memorial Medical Center — Worcester, Massachusetts
- University of Minnesota Medical Center — Minneapolis, Minnesota
- Columbia University Irvine Medical Center — New York, New York
- Memorial Sloan Kettering Cancer Center — New York, New York
- University of Rochester Medical Center — Rochester, New York
- Montefiore Medical Center — The Bronx, New York
- Wake Forest University Health Sciences — Winston-Salem, North Carolina
- Cleveland Clinic — Cleveland, Ohio
- University of Texas Medical Branch — Galveston, Texas
- UT Health Houston — Houston, Texas
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.