Preoperative Fasting vs. Not Fasting in Critically Ill Patients

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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Conditions

• Critical Illness
• Surgical Procedure, Unspecified
• Pulmonary Aspiration
• Fasting

Interventions

OTHER

Fasting

Process: Fasting pre-procedure Tube feeding will be stopped at least 8 hours before the patient's scheduled surgery or procedure time.

OTHER

Not fasting

Process: Not fasting pre-procedure Tube feeding will be continued until patient transfer to the operating room/procedure area.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• Columbia University

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Alexander Nagrebetsky, MD, MSC · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-28

Primary Completion

2028-02-29

Completion

2028-05-31

Countries

• United States

Study Locations