Preoperative Fasting vs. Not Fasting in Critically Ill Patients
Start Date
4/28/2025
Completion Date
5/1/2028
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. * Data from routine electronic medical records will be reviewed to determine how participants are doing 3 months after their procedure. '
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Fasting
Not fasting
Conditions
Locations
Stanford Medical Center
Palo Alto, California 94305
United States
UCSF Medical Center Parnassus
San Francisco, California 94143
United States
University of Colorado Medical Center
Aurora, Colorado 80045
United States
University of Miami Hospital
Miami, Florida 33136
United States
McGaw Medical Center of Northwestern
Chicago, Illinois 60611
United States
Rush University Medical Center
Chicago, Illinois 60612
United States
University of Maryland Medical Center
Baltimore, Maryland 21201
United States
Mass General Hospital
Boston, Massachusetts 02114
United States
Brigham & Women's Hospital
Boston, Massachusetts 02115
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts 01655
United States
University of Minnesota Medical Center
Minneapolis, Minnesota 55455
United States
Columbia University Irvine Medical Center
New York, New York 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
University of Rochester Medical Center
Rochester, New York 14642
United States
Montefiore Medical Center
The Bronx, New York 10467
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27103
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
University of Texas Medical Branch
Galveston, Texas 77555
United States
UT Health Houston
Houston, Texas 77030
United States