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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether fasting before a medical procedure affects recovery in critically ill patients on a breathing machine and receiving tube feeding. Researchers aim to determine if not fasting increases the risk of lung complications and impacts recovery times, infection rates, and overall health outcomes. Participants will be randomly assigned to either fast for at least 8 hours before their procedure or not fast at all. The trial seeks patients currently in the ICU who are receiving tube feeding and have an upcoming non-emergency procedure scheduled. As an unphased trial, this study offers patients the opportunity to contribute to important research that could enhance care for future ICU patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that fasting or not fasting before a procedure is safe for critically ill patients?

Research has shown that fasting before a medical procedure can have mixed effects on safety. Some studies found that prolonged fasting might slow recovery and increase the risk of nausea or vomiting after surgery. In certain cases, such as multiple bone surgeries, extended fasting has been linked to a higher risk of poor nutrition and a 15% higher chance of death.

Conversely, research suggests that not fasting might be just as safe and could improve patient satisfaction. Patients often feel better when they don't fast for long periods before a procedure.

Overall, both fasting and not fasting have pros and cons regarding safety. Each option can affect patients differently, so these factors must be considered carefully. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the effects of fasting versus not fasting before surgery or procedures for critically ill patients. Unlike traditional protocols where patients might fast before operations to reduce the risk of complications, this trial investigates whether continuing tube feeding up to the procedure time might offer benefits, such as improved energy levels and better overall outcomes. By evaluating these two approaches, the trial aims to provide insights into optimizing pre-operative care and potentially revising guidelines to enhance recovery and health in critically ill patients.

What evidence suggests that fasting or not fasting before a procedure is effective for recovery in critically ill patients?

This trial will compare fasting with not fasting before medical procedures in critically ill patients. Research has shown that not eating before a medical procedure might affect recovery in these patients. One study examined patients who fasted and those who didn't, revealing differences in safety and effectiveness. Participants in the fasting arm of this trial will stop tube feeding at least 8 hours before their procedure, potentially reducing the risk of food entering the lungs, a concern for ventilated patients. Meanwhile, participants in the not fasting arm will continue tube feeding until transfer to the operating room or procedure area. However, the impact of fasting on recovery times and hospital stays remains unclear. Some patients believe fasting improves surgery outcomes, but more solid evidence is needed to confirm this. ^{4 6 7 8 9}

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12357572/

Advances in Intermittent Fasting Applications for Critically ... This review summarizes the current evidence regarding the physiological mechanisms, implementation strategies, clinical outcomes, and safety ...

2. pcori.org pcori.org/research-results/2023/preoperative-fasting-versus-not-fasting-critically-ill-adults

Preoperative Fasting Versus Not Fasting in Critically Ill Adults This study compares the safety and clinical effectiveness of fasting versus not fasting in critically ill adults supported on a ventilator ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9953889/

Real-World Evidence: How Long Do Our Patients Fast ... Most patients believed that adherence to fasting recommendations would improve the outcome of surgery (“yes” 68.0% (628), “unsure” 21.6% (200), ...

4. brieflands.com brieflands.com/journals/jnms/articles/141423.pdf

Fasting duration in patients undergoing elective surgery Conclusion: The results denote the patients of different age groups endure long fasting period considerably affecting the illness process and surgery outcome.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06751043

Preoperative Fasting vs. Not Fasting in Critically Ill Patients 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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11701341/

Enhancing Compliance With Preoperative Fasting Guidelines Additionally, extended fasting times have been associated with delayed recovery, increased postoperative nausea and vomiting (PONV), and ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1553838925004579

a Bayesian meta-analysis of randomized clinical trials Recent studies suggest that non-fasting protocols may be equally safe and increase patient satisfaction. We performed a meta-analysis of ...

8. asahq.org asahq.org/about-asa/newsroom/news-releases/2024/10/prolonged-fasting-for-multiple-orthopedic-surgeries-raises-risk-of-malnutrition

Prolonged Fasting for Multiple Orthopedic Surgeries ... Prolonged Fasting for Multiple Orthopedic Surgeries Raises Risk of Malnutrition, Leading to Worse Outcomes · were at least 15% more likely to die ...

9. academic.oup.com academic.oup.com/ejcts/article/67/8/ezaf238/8205746

European Journal of Cardio-Thoracic Surgery | Oxford Academic Key safety variables were fast-track failure rate and proportion of readmissions from the ward within 72 hours. Statistical analysis. Data are ...