Preoperative Fasting vs. Not Fasting in Critically Ill Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital

About 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.

* Data from routine electronic medical records will be reviewed to determine how participants are doing 3 months after their procedure.

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Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fasting
  • Not fasting

Treatment groups

1,072 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Massachusetts General Hospital

Lead sponsor

Patient-Centered Outcomes Research Institute

Collaborator

Columbia University

Collaborator