Preoperative Fasting vs. Not Fasting in Critically Ill Patients (NCT06751043) | Clinical Trial Compass
RecruitingNot Applicable
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
United States1,072 participantsStarted 2025-04-28
Plain-language 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.
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Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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:
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
✕
What they're measuring
1
Days alive and free from mechanical ventilation on postoperative day 28.
✕. 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