Fasting for Critical Illness

(FEEDS Trial)

Recruiting at 1 trial location

Overseen By Alexander Nagrebetsky, MD, MSC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Burns, Emergency procedure, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

1072 Participants Needed

Trial Summary

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. '

Research Team

Alexander Nagrebetsky, MD, MSC

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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

I need sedation or anesthesia for procedures.

I have a stable breathing tube that won't be removed before the procedure.

I am on tube feeding that exceeds 10 mL/hr and won't stop it before the procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

8 hours

In-hospital monitoring

Procedure and Immediate Postoperative Monitoring

Participants undergo the scheduled procedure and are monitored for immediate postoperative outcomes, including pulmonary complications and nutritional intake.

72 hours

In-hospital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including recovery times, hospital stays, and infection rates.

90 days

Medical record review and phone call at 3 months

Treatment Details

Interventions

• Fasting
• Not fasting

Trial Overview The study compares two approaches: fasting at least 8 hours before a procedure versus stopping tube feeding just before. It looks at lung complications, recovery time, hospital stay length, infection rates, organ support needs, safety measures, and nutritional effects on outcomes.

Participant Groups

Group I: Fasting Active Control 1 Intervention

Patients randomized to the Fasting arm will have tube feeding stopped at least 8 hours before the scheduled surgery or procedure time.

Group II: Not Fasting Active Control 1 Intervention

Patients randomized to the Not Fasting arm will have tube feeding continued until transfer to the operating room/procedure area.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+