Fasting for Critical Illness
(FEEDS Trial)
What You Need to Know Before You Apply
What is the purpose of 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.* 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.'
Who Is on the Research Team?
Alexander Nagrebetsky, MD, MSC
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
This trial is for critically ill adults (18+) in the ICU who are on a breathing machine with tube feeding, and have procedures scheduled that don't involve the digestive system or lungs. They shouldn't need certain body positions like prone or head-down during the procedure, and their airway should be secure without plans to remove it before the procedure.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative Intervention
Participants are randomized to either fasting or not fasting before the procedure. Fasting group stops tube feeding at least 8 hours before the procedure, while the not fasting group continues feeding until transfer.
Procedure and Immediate Postoperative Monitoring
Participants undergo the scheduled procedure and are monitored for immediate postoperative outcomes, including pulmonary complications and nutritional intake.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including recovery times, hospital stays, and infection rates.
What Are the Treatments Tested in This Trial?
Interventions
- Fasting
- Not fasting
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Columbia University
Collaborator