Preoperative Fasting vs. Not Fasting in Critically Ill Patients

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Fasting — OTHER
  Process: Fasting pre-procedure Tube feeding will be stopped at least 8 hours before the patient's scheduled surgery or procedure time.
• Not fasting — OTHER
  Process: Not fasting pre-procedure Tube feeding will be continued until patient transfer to the operating room/procedure area.

Study Details

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. '

Key Dates

Start date

Apr 28, 2025

Status verified

Jan 2026

Primary completion

Feb 29, 2028

Completion

May 31, 2028

Study Design

Enrollment

1,072 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Fasting
  Patients randomized to the Fasting arm will have tube feeding stopped at least 8 hours before the scheduled surgery or procedure time.
• Active Comparator: Not Fasting
  Patients randomized to the Not Fasting arm will have tube feeding continued until transfer to the operating room/procedure area.

Primary Outcome Measure

Days alive and free from mechanical ventilation on postoperative day 28. [ Time Frame: Post-operative day 28 ]

Central Contacts

• Alexander Nagrebetsky, MD, MSC
  617-724-3292
  [email protected]

Locations (19)

Find similar trials in Palo Alto, CA

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