An interventional study of Fasting and Not fasting in Critical Illness, Surgical Procedure, Unspecified and Pulmonary Aspiration, sponsored by Massachusetts General Hospital. Recruiting at 19 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Prevention
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:
Researchers will compare not fasting and fasting to see if it has an effect on recovery.
Participants will:
Be monitored via medical record for amount of protein and calories received, and any complications related to fasting/not fasting.
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Patient Population: Critically ill patients in the ICU who are: mechanically ventilated, receiving tube feeding (enteral nutrition), with a planned surgery or procedure. Up to 1072 subjects will be enrolled.
Phase III pragmatic multicenter parallel-group randomized controlled non-inferiority trial with patient-level randomization and assessor blinding.
Enrollment Period: Approximately two years.
Aims:
Study participants will be randomized with a 1:1 allocation ratio to one of the following preprocedural interventions:
Planned eligible procedure (Examples are listed in Appendix C) with anesthesia care or nursing sedation. Eligible procedures are defined as non-emergent diagnostic or therapeutic interventions that:
Are performed in the operating room, non-operating room procedural areas, or at the patient's bedside.
All ICU types are eligible: surgical, medical, cardiac, neurological, trauma, mixed etc.
Secure airway is defined as a cuffed endotracheal tube or a cuffed tracheostomy tube.
Exclusion Criteria
Patients randomized to the Fasting arm will have tube feeding stopped at least 8 hours before the scheduled surgery or procedure time.
Other: Fasting
Patients randomized to the Not Fasting arm will have tube feeding continued until transfer to the operating room/procedure area.
Other: Not fasting
Process: Fasting pre-procedure Tube feeding will be stopped at least 8 hours before the patient's scheduled surgery or procedure time.
Process: Not fasting pre-procedure Tube feeding will be continued until patient transfer to the operating room/procedure area.
Days alive and free from mechanical ventilation on postoperative day 28.
Defined as the days alive and free of organ support (dialysis, assisted ventilation, and vasopressors) to day 28. Participants will need to be free of all three components (assisted ventilation, vasopressors, new renal replacement therapy) to qualify for a day alive and free from organ failures. Patients on chronic dialysis will not be scored for the new renal failure free component of this outcome.
Time frame: Post-operative day 28
Postoperative mortality
Death from any cause at any location, including deaths after withdrawal of care.
Time frame: Post-operative day 28
Ventilator-free days in survivors
28 minus last post-operative day of mechanical ventilation assessed only in survivors at post-operative day 28. Non-survivors are excluded
Time frame: Post-operative day 28
All-cause, all-location mortality
Death from any cause at any location, including deaths after withdrawal of care.
Time frame: Post-operative day 90
Length of ICU stay
90 minus the last post-operative day of ICU admission.
Time frame: Post-operative day 90
Length of hospital stay
90 minus the last post-operative day of hospital/facility admission.
Time frame: Post-operative day 90
Days alive and without life support54 Days alive and without life support
90 minus the last post-operative day of mechanical ventilation, renal replacement therapy, or circulatory support (ECMO, vasopressor or inotrope), whichever is used last.
Time frame: Post-operative day 90
Proportion of patients alive and at home
Proportion of patients who are alive and at home or at pre-index hospitalization level of care.
Time frame: Post-operative day 90
New surgical site infection
Documentation of superficial incisional or organ/space infection after index procedure in routine medical records
Time frame: Post-operative day 90
New bacteremia
Bacteremia in patients without pre-study intervention evidence of bacteremia during the same hospital admission.
Time frame: Post-operative day 90
Perioperative pulmonary aspiration
Periprocedural pulmonary aspiration of gastric contents documented in routine medical records.
Time frame: Time of procedure start +/- 24 hours
Perioperative Hyperglycemia
Routinely collected blood glucose of \> 180 mg/dL on at least one measurement.
Time frame: Time of procedure start +/- 24 hours
Perioperative hypoglycemia
At least one episode of routinely collected blood glucose of 41 to 70 mg/dL (moderate hypoglycemia) or ≤ 40 mg/dL (severe hypoglycemia).
Time frame: Time of procedure start +/- 24 hours
Preoperative fasting duration
Time from last routinely documented non-trophic (\> 10 mL/hr) tube feeding to procedure start.
Time frame: Time of procedure start - 72 hours
Postoperative fasting duration
Time from procedure end to the first routinely documented non-trophic (\>10 mL/hr) tube feeding volume/rate.
Time frame: Time of procedure start + 72 hours
Perioperative fasting duration
Duration of preoperative plus postoperative fasting.
Time frame: Time of procedure start +/- 72 hours
Preoperative calories delivered
Total number of calories delivered via tube feeding within 24 and 72 hours prior to procedure.
Time frame: Time of procedure - 72 and -24 hours
Postoperative calories delivered
Total number of calories delivered via tube feeding within 24 and 72 hours after the procedure.
Time frame: Time of procedure + 72 and + 24 hours
Perioperative calories delivered
Total number of calories delivered via tube feeding within 24 and 72 hours of the procedure.
Time frame: Time of procedure +/- 72 and +/- 24 hours
Preoperative protein delivered
Total amount of protein delivered via tube feeding within 24 and 72 hours prior to procedure.
Time frame: Time of procedure - 72 and -24 hours
Postoperative protein delivered
Total amount of protein delivered via tube feeding within 24 and 72 hours after the procedure.
Time frame: Time of procedure + 72 and + 24 hours
Perioperative protein delivered
Total amount of protein delivered via tube feeding within 24 and 72 hours of the procedure
Time frame: Time of procedure +/- 72 and +/- 24 hours
Plan to share: Yes — Study sites of this trial will share deidentified data through eCRF with the Statistical and Data Coordinating Center. The shared data will include patient baseline characteristics (clinical and demographic), data on trial interventions, and outcome data.
Supporting information: Study protocol, Sap, Icf
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Massachusetts General Hospital