Preoperative Fasting Vs. Not Fasting in Critically Ill Patients

Not Applicable

Not yet recruiting

• Conditions: Critical Illness; Surgical Procedure, Unspecified; Pulmonary Aspiration; Fasting

• Registration Number: NCT06751043
• Lead Sponsor: Massachusetts General Hospital

Brief 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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Detailed Description

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:

* Aim 1: To compare the risk of pulmonary complications and mortality from: (1) perioperative pulmonary aspiration6,33,34 due to not fasting vs. (2) systemic effects of nutritional loss18-24 due to preoperative fasting. We will quantify the risk of pulmonary complications and mortality as the number of postoperative days alive and free from mechanical ventilation (DAFV)35,36 in the target population of critically ill patients with a secure airway who undergo interventional procedures.

* Aim 2: To compare length of ICU and hospital stay, discharge to home, need for organ support, infectious complications, safety outcomes, and nutritional outcomes in tube-fed mechanically ventilated patients with a secure airway who are fasted vs. not fasted prior to procedure.

* Aim 3: To define the relationship between perioperative fasting duration, calorie/protein delivery, and clinical outcomes in mechanically ventilated patients who receive tube feeding.

Study participants will be randomized with a 1:1 allocation ratio to one of the following preprocedural interventions:

1. Fasting - stopping tube feeding at least 8 hours prior to the scheduled procedure time;

2. Not fasting - tube feeding until call for transfer to the procedure area.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Study Start: 2025-05
• Primary Completion: 2028-02
• Study Completion: 2028-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1072

Inclusion Criteria

1. Age ≥ 18

2. Current admission to ICU

3. Secure airway with no plans for its removal prior to procedure

4. Current non-trophic (> 10 mL/hr) tube (enteral) feeding with no plans to discontinue prior to procedure for reasons other than preoperative fasting

5. Planned eligible procedure with anesthesia care or nursing sedation. Eligible procedures are defined as non-emergent diagnostic or therapeutic interventions that:

   • Do NOT have a well-established practice of preoperative fasting. (For example, bedside placement of a vascular catheter [arterial, central venous, peripheral venous] by the ICU team is NOT eligible for this trial since it has a widely established practice of no preoperative fasting and is not generally scheduled for a specific time.)
   • Are NOT performed on the gastrointestinal tract or lung/airway.
   • Do NOT require prone or Trendelenburg (head-down) positioning.
   • Typically require procedural sedation or anesthesia care.
   • Generally, are scheduled for a specific time (although this time can change, or procedure may be cancelled).
   • Are performed in the operating room, non-operating room procedural areas, or at the patient's bedside.

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Exclusion Criteria

1. Inability to obtain informed consent
2. Inability to enroll and randomize > 8 hours prior to planned procedure time
3. Inability to deliver trial interventions
4. Expected survival < 48 hours as determined by the enrolling physician-investigator
5. Critically ill burn patient
6. Emergency procedure
7. Gastrointestinal tract or airway/lung procedure
8. Plan for prone or Trendelenburg (head down) positioning during the procedure
9. Major impairment of gastrointestinal motility or major structural disease of the gastrointestinal tract (e.g., severe gastroparesis, bowel obstruction, severe ileus, severely compromised lower esophageal sphincter, active gastrointestinal bleeding)
10. Plan for postoperative extubation in the procedure area
11. Prisoner
12. Pregnant woman, woman of childbearing potential without a documented negative urine or serum pregnancy test during the current hospitalization, or woman who is breast feeding

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Days alive and free from mechanical ventilation on postoperative day 28.	Post-operative 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.

Secondary Outcome Measures

Name	Time	Method
Postoperative mortality	Post-operative day 28	Death from any cause at any location, including deaths after withdrawal of care.
Ventilator-free days in survivors	Post-operative day 28	28 minus last post-operative day of mechanical ventilation assessed only in survivors at post-operative day 28. Non-survivors are excluded
All-cause, all-location mortality	Post-operative day 90	Death from any cause at any location, including deaths after withdrawal of care.
Length of ICU stay	Post-operative day 90	90 minus the last post-operative day of ICU admission.
Length of hospital stay	Post-operative day 90	90 minus the last post-operative day of hospital/facility admission.
Days alive and without life support54 Days alive and without life support	Post-operative day 90	90 minus the last post-operative day of mechanical ventilation, renal replacement therapy, or circulatory support (ECMO, vasopressor or inotrope), whichever is used last.
Proportion of patients alive and at home	Post-operative day 90	Proportion of patients who are alive and at home or at pre-index hospitalization level of care.
Health-related quality of life	Post-operative day 90	Short-Form 20
New surgical site infection	Post-operative day 90	Documentation of superficial incisional or organ/space infection after index procedure in routine medical records
New bacteremia	Post-operative day 90	Bacteremia in patients without pre-study intervention evidence of bacteremia during the same hospital admission.
Perioperative pulmonary aspiration	Time of procedure start +/- 24 hours	Periprocedural pulmonary aspiration of gastric contents documented in routine medical records.
Perioperative Hyperglycemia	Time of procedure start +/- 24 hours	Routinely collected blood glucose of \> 180 mg/dL on at least one measurement.
Perioperative hypoglycemia	Time of procedure start +/- 24 hours	At least one episode of routinely collected blood glucose of 41 to 70 mg/dL (moderate hypoglycemia) or ≤ 40 mg/dL (severe hypoglycemia).
Preoperative fasting duration	Time of procedure start - 72 hours	Time from last routinely documented non-trophic (\> 10 mL/hr) tube feeding to procedure start.
Postoperative fasting duration	Time of procedure start + 72 hours	Time from procedure end to the first routinely documented non-trophic (\>10 mL/hr) tube feeding volume/rate.
Perioperative fasting duration	Time of procedure start +/- 72 hours	Duration of preoperative plus postoperative fasting.
Preoperative calories delivered	Time of procedure - 72 and -24 hours	Total number of calories delivered via tube feeding within 24 and 72 hours prior to procedure.
Postoperative calories delivered	Time of procedure + 72 and + 24 hours	Total number of calories delivered via tube feeding within 24 and 72 hours after the procedure.
Perioperative calories delivered	Time of procedure +/- 72 and +/- 24 hours	Total number of calories delivered via tube feeding within 24 and 72 hours of the procedure.
Preoperative protein delivered	Time of procedure - 72 and -24 hours	Total amount of protein delivered via tube feeding within 24 and 72 hours prior to procedure.
Postoperative protein delivered	Time of procedure + 72 and + 24 hours	Total amount of protein delivered via tube feeding within 24 and 72 hours after the procedure.
Perioperative protein delivered	Time of procedure +/- 72 and +/- 24 hours	Total amount of protein delivered via tube feeding within 24 and 72 hours of the procedure