Preoperative Fasting vs. Not Fasting in Critically Ill Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
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Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Fasting
Other interventionProcess: Fasting pre-procedure Tube feeding will be stopped at least 8 hours before the patient's scheduled surgery or procedure time.
Not fasting
Other interventionProcess: Not fasting pre-procedure Tube feeding will be continued until patient transfer to the operating room/procedure area.
Treatment groups
1,072 Participants
are divided into 2 treatment groupsGroup A: FastingActive comparator 1 intervention
Group B: Not FastingActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 28Secondary outcomes
1
Postoperative mortality
Death from any cause at any location, including deaths after withdrawal of care.
Time frame
Post-operative day 282
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 283
All-cause, all-location mortality
Death from any cause at any location, including deaths after withdrawal of care.
Time frame
Post-operative day 904
Length of ICU stay
90 minus the last post-operative day of ICU admission.
Time frame
Post-operative day 90Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Columbia University
Collaborator
Source ClinicalTrials.gov