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NCT06751043 · ClinicalTrials.gov registry record · NA
Preoperative Fasting vs. Not Fasting in Critically Ill Patients
A NA study of Critical Illness and Fasting, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 1,072
- Enrollment target
- 19
- Study locations
NCT06751043: Recruiting NA study of Critical Illness and Fasting, sponsored by Massachusetts General Hospital.
NCT06751043 is a NA study of Critical Illness and Fasting that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 1,072 participants, below the 3,127-participant average among 91 other Critical Illness trials with a reported enrollment target (66% lower). The trial reports 19 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06751043, a NA study of Critical Illness and Fasting, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 1,072 participants
- Enrollment target
- 19
- Study locations
Study 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. '
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Fasting
- OTHER Not fasting
Study Locations (19)
New York
- Columbia University Irvine Medical Center - New York
- Memorial Sloan Kettering Cancer Center - New York
- University of Rochester Medical Center - Rochester
- Montefiore Medical Center - The Bronx
Massachusetts
- Mass General Hospital - Boston
- Brigham & Women's Hospital - Boston
- University of Massachusetts Memorial Medical Center - Worcester
California
- Stanford Medical Center - Palo Alto
- UCSF Medical Center Parnassus - San Francisco
Illinois
- McGaw Medical Center of Northwestern - Chicago
- Rush University Medical Center - Chicago
Texas
- University of Texas Medical Branch - Galveston
- UT Health Houston - Houston
Colorado
- University of Colorado Medical Center - Aurora
Florida
- University of Miami Hospital - Miami
Maryland
- University of Maryland Medical Center - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,072 participants |
| Start Date | 2025-04-28 |
| Est. Completion | 2028-05 |
| Phase | NA |
What NCT06751043 shows while recruiting
NCT06751043 is an interventional study that assigns participants to a tested intervention. Its 1,072 participants enrollment target places it among the larger protocols in the corpus, below the 3,127-participant average among 91 other Critical Illness trials with a reported enrollment target (66% lower).
The record links to 4 conditions, with Critical Illness appearing as the primary indexed condition, and to 2 interventions - of which Fasting is the first listed.
NCT06751043 lists 19 locations in 11 states (New York, Massachusetts, California).
Frequently Asked Questions
What is clinical trial NCT06751043 about?
NCT06751043 is a clinical study titled "Preoperative Fasting vs. Not Fasting in Critically Ill Patients". 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 ...
What is the current status of trial NCT06751043?
This trial is currently recruiting. It is a NA study. The enrollment target is 1,072 participants. The study started on 2025-04-28. Estimated completion is 2028-05.
What conditions does trial NCT06751043 study?
This clinical trial studies the following conditions: Critical Illness, Fasting, Surgical Procedure, Unspecified, Pulmonary Aspiration.
What interventions are being tested in trial NCT06751043?
The interventions under investigation include: Fasting (OTHER), Not fasting (OTHER).
Who is sponsoring clinical trial NCT06751043?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06751043 being conducted?
This trial has 19 study locations across California, Colorado, Florida, Illinois, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06751043's enrollment target sits among peer trials
1,072 20th of 91 higher than 72 of 91 other Critical Illness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Critical Illness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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