Critical IllnessFEEDSNCT06751043
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
A study testing Fasting and Not fasting in people with Critical Illness and Surgical Procedure, Unspecified, run by Massachusetts General Hospital at 19 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Surgical Procedure, Unspecified, Pulmonary Aspiration
- What is being tested?
- Fasting and Not fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,072 participants
- Where
- 19 sitesUnited States
- Study dates
- 28 Apr 2025to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- 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:
- 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.)
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- Do NOT require fasting for preoperative gastrointestinal tract preparation
- Do NOT require removal/replacement of the endotracheal or tracheostomy tube
- 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.
- 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.
- Patients with all types of feeding tubes are eligible, regardless of tube insertion site (nasal, oral, surgically implanted) and tube tip location (pre- and post-pyloric) †As determined by the enrolling physician-investigator
Who cannot join
- 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
- Critically ill burn patient
- Emergency procedure
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- a. Gastrointestinal tract procedure that requires fasting based on surgical indications or b. airway/lung procedure that requires removal of endotracheal or tracheostomy tube
- Plan for prone or Trendelenburg (head down) positioning during most of the procedure
- 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)
- Plan for postoperative extubation in the procedure area
- Prisoner
- 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
- Refusal to enroll patient by treating physician
- Extracorporeal Membrane Oxygenation (ECMO) at the time of potential enrollment, except patients scheduled for ECMO decannulation as the study procedure and patients expected to be off of ECMO at the time of study procedure.
- Chronic mechanical ventilation at pre-admission level of care
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
United States19 sites, 18 recruiting
- Not yet recruiting
University of Colorado Medical Center
Aurora, Colorado, 80045
Ana Fernandez-Bustamante, MD, PhD, FASA, 720-848-0000
- Not yet recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Megan Anders, MD, (410) 328-8600, manders@som.umaryland.edu
- Recruiting
Mass General Hospital
Boston, Massachusetts, 02114
Alex Nagrebetsky
- Recruiting
Brigham & Women's Hospital
Boston, Massachusetts, 02115
Gyorgy Frendl
- Recruiting
McGaw Medical Center of Northwestern
Chicago, Illinois, 60611
Ravindra Gupta, MD, FASA, FCCP, (312) 503-7975, Ravindra.Gupta@nm.org
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Alisha Sachdev, MD, (888) 352-7874, Alisha_Sachdev@rush.edu
- Active, not recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
University of Texas Medical Branch
Galveston, Texas, 77555
Marcos Vidal Melo, MD, PhD, 409-772-1011, mfvidalm@UTMB.EDU
- Not yet recruiting
UT Health Houston
Houston, Texas, 77030
Turan Mehmet, MD, 713-486-1000, mehmet.a.turan@uth.tmc.edu
- Not yet recruiting
University of Miami Hospital
Miami, Florida, 33136
Alexander Fort III, MD, 305-243-4000, acfort@med.miami.edu
- Recruiting
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
Benjamin Keith, MD, 855-324-7843, keith200@umn.edu
- Recruiting
Columbia University Irvine Medical Center
New York, New York, 10032
Vivek Moitra, MD, FASA, FCCP, (212) 305-2500, vm2161@cumc.columbia.edu
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
David Amar, MD, 212-639-2000, amard@mskcc.org
- Recruiting
Stanford Medical Center
Palo Alto, California, 94305
Pedro Tanaka, MD, PhD, MACM, (650) 498-6000, ptanaka@stanford.edu
- Not yet recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Jacob Nadler, MD, PhD, FASA, (585) 275-2100, Jacob_Nadler@URMC.Rochester.edu
- Recruiting
UCSF Medical Center Parnassus
San Francisco, California, 94143
Lee-lynn Chen, MD, (415) 567-6600, Lee-lynn.Chen@ucsf.edu
- Recruiting
Montefiore Medical Center
The Bronx, New York, 10467
Michael Kiyatkin, MD, 718-920-4321, mkiyatkin@montefiore.org
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27103
Ashish Khanna, MD, FCCP, FCCM, 336-758-5000, akhanna@wakehealth.edu
- Recruiting
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
Guido Musch, MD, MBA, (508) 334-1000, Guido.Musch@umassmed.edu
About this study
Official title: FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway
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?
Read more
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.
'
Read the 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:
- Fasting - stopping tube feeding at least 8 hours prior to the scheduled procedure time;
- Not fasting - tube feeding until call for transfer to the procedure area.
- Being tested
- Fasting, Not fasting
- Keywords
- pulmonary aspiration, enteral nutrition, tube feeding, preoperative fasting, perioperative medicine, surgery in critically ill, procedures in critically ill, nutrition in critical illness, perioperative safety, preoperative management, preoperative fasting in secure airway, anesthesia in critically ill
- Medical subject headings
- Critical Illness, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
Process: Fasting pre-procedure
Tube feeding will be stopped at least 8 hours before the patient's scheduled surgery or procedure time.
Not fastingOther
Process: Not fasting pre-procedure
Tube feeding will be continued until patient transfer to the operating room/procedure area.
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Active comparator | Patients randomized to the Fasting arm will have tube feeding stopped at least 8 hours before the scheduled surgery or procedure time. Receives: Other: Fasting |
| Not Fasting | Active comparator | Patients randomized to the Not Fasting arm will have tube feeding continued until transfer to the operating room/procedure area. Receives: Other: Not fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Post-operative day 28
Secondary outcomes (21)
Postoperative mortality
Death from any cause at any location, including deaths after withdrawal of care.
Measured: 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
Measured: Post-operative day 28
All-cause, all-location mortality
Death from any cause at any location, including deaths after withdrawal of care.
Measured: Post-operative day 90
Length of ICU stay
90 minus the last post-operative day of ICU admission.
Measured: Post-operative day 90
Length of hospital stay
90 minus the last post-operative day of hospital/facility admission.
Measured: 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.
Measured: 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.
Measured: Post-operative day 90
New surgical site infection
Documentation of superficial incisional or organ/space infection after index procedure in routine medical records
Measured: Post-operative day 90
New bacteremia
Bacteremia in patients without pre-study intervention evidence of bacteremia during the same hospital admission.
Measured: Post-operative day 90
Perioperative pulmonary aspiration
Periprocedural pulmonary aspiration of gastric contents documented in routine medical records.
Measured: Time of procedure start +/- 24 hours
Perioperative Hyperglycemia
Routinely collected blood glucose of > 180 mg/dL on at least one measurement.
Measured: 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).
Measured: Time of procedure start +/- 24 hours
Preoperative fasting duration
Time from last routinely documented non-trophic (> 10 mL/hr) tube feeding to procedure start.
Measured: 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.
Measured: Time of procedure start + 72 hours
Perioperative fasting duration
Duration of preoperative plus postoperative fasting.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Time of procedure +/- 72 and +/- 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start28 Apr 2025
- Primary completionFeb 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III pragmatic multicenter parallel-group randomized controlled non-inferiority trial with patient-level randomization and assessor blinding. If non-inferiority is demonstrated, we will perform a pre-specified superiority test.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,072 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Columbia University
- Responsible party
- Principal investigator, Alexander Nagrebetsky, MD MSc, Massachusetts General Hospital
- Investigators
- Alexander Nagrebetsky, MD, MSC, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06751043
- Sponsor's protocol ID
- 2024P003035
- Other IDs
- BPS-2023C1-31273
- Acronym
- FEEDS
- Status last verified
- Jun 2026
- First submitted
- 20 Dec 2024
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FEEDS Trial - Fasting Preprocedurally in Enteral Nutrition: Evaluation of Divergent Approaches in Secure Airway
- ClinicalTrials.gov ID
- NCT06751043
- Acronym / sponsor ID
- FEEDS / 2024P003035
- Keywords
- pulmonary aspiration, enteral nutrition, tube feeding, preoperative fasting, perioperative medicine, surgery in critically ill, procedures in critically ill, nutrition in critical illness
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,072 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Columbia University
- Study start
- 28 Apr 2025 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Fasting - stopping tube feeding at least 8 hours prior to the scheduled procedure time;
- Not fasting - tube feeding until call for transfer to the procedure area.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Phase III pragmatic multicenter parallel-group randomized controlled non-inferiority trial with patient-level randomization and assessor blinding. If non-inferiority is demonstrated, we will perform a pre-specified superiority test.
| Arm | Type | Receives |
|---|---|---|
| Fasting | Active comparator | Other: FastingPatients randomized to the Fasting arm will have tube feeding stopped at least 8 hours before the scheduled surgery or procedure time. |
| Not Fasting | Active comparator | Other: Not fastingPatients randomized to the Not Fasting arm will have tube feeding continued until transfer to the operating room/procedure area. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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
- 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:
Key exclusion criteria (15 listed)
- 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
- Critically ill burn patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FastingProcess: Fasting pre-procedure Tube feeding will be stopped at least 8 hours before the patient's scheduled surgery or procedure time. | Other | Fasting |
| Not fastingProcess: Not fasting pre-procedure Tube feeding will be continued until patient transfer to the operating room/procedure area. | Other | Not Fasting |
Primary outcome
Days alive and free from mechanical ventilation on postoperative day 28.
Time frame: 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.
21 secondary outcomes
Postoperative mortality
Time frame: Post-operative day 28
Ventilator-free days in survivors
Time frame: Post-operative day 28
All-cause, all-location mortality
Time frame: Post-operative day 90
Length of ICU stay
Time frame: Post-operative day 90
Length of hospital stay
Time frame: Post-operative day 90
Days alive and without life support54 Days alive and without life support
Time frame: Post-operative day 90
Proportion of patients alive and at home
Time frame: Post-operative day 90
New surgical site infection
Time frame: Post-operative day 90
New bacteremia
Time frame: Post-operative day 90
Perioperative pulmonary aspiration
Time frame: Time of procedure start +/- 24 hours
Perioperative Hyperglycemia
Time frame: Time of procedure start +/- 24 hours
Perioperative hypoglycemia
Time frame: Time of procedure start +/- 24 hours
Preoperative fasting duration
Time frame: Time of procedure start - 72 hours
Postoperative fasting duration
Time frame: Time of procedure start + 72 hours
Perioperative fasting duration
Time frame: Time of procedure start +/- 72 hours
Preoperative calories delivered
Time frame: Time of procedure - 72 and -24 hours
Postoperative calories delivered
Time frame: Time of procedure + 72 and + 24 hours
Perioperative calories delivered
Time frame: Time of procedure +/- 72 and +/- 24 hours
Preoperative protein delivered
Time frame: Time of procedure - 72 and -24 hours
Postoperative protein delivered
Time frame: Time of procedure + 72 and + 24 hours
Perioperative protein delivered
Time frame: Time of procedure +/- 72 and +/- 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alexander Nagrebetsky, MD, MSC principal investigator
Massachusetts General Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting and Not fasting in people with Critical Illness and Surgical Procedure, Unspecified, run by Massachusetts General Hospital at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexander Nagrebetsky, MD, MSC (617-724-3292, anagrebetsky@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days alive and free from mechanical ventilation on postoperative day 28. (time frame: Post-operative day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.