Dietary Restriction in Vascular Surgery
Completed · Not applicable
Conditions studied: Vascular Diseases, Surgery
In brief
A randomized, controlled trial to evaluate patient compliance and biologic mechanisms of a short-term pre-operative Protein-Calorie Restriction (PCR) diet in comparison to a normal ad libitum diet for 4 days before elective vascular surgery involving a major operation. This study is a step in the long-term primary scientific objective to test the hypothesis that brief up regulation of endogenous H2S via pre-operative PCR in elective major surgery improves clinical outcomes in humans. After a successful pilot study of the PCR diet conducted inpatient before carotid endarterectomy, the investigators now aim to expand the study to at home diet among a variety of vascular surgery procedures.
Key facts
- Study ID
- NCT04013412
- Run by
- Brigham and Women's Hospital
- People needed
- 19
- Starts
- 2018-12-31
- Expected to finish
- 2020-03-31
- Last updated by the study team
- 2020-09-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients greater than 18 years old who present for one of the following elective procedures at Brigham and Women's Hospital
- Carotid artery endarterectomy
- Aortic/iliac aneurysm repair (open, and endovascular if groin cut down planned)
- Open lower extremity arterial procedures (bypasses, aneurysm repair, arterial and bypass graft reconstructions)
- Major amputation of the lower extremity (below knee and above knee amputations).
- Open hemodialysis access procedures
You may not qualify if…
- Patient intolerance or allergy to any of the ingredients in the PCR diet
- Active infection
- Pregnancy
- Malnutrition, based on abnormally low serum albumin (lower than 3 g/dL)
- Uncontrolled diabetes (HgbA1c greater than 12%)
- Substance dependency that could interfere with protocol adherence and assent as determined by the PI
- Active non-cutaneous cancer under treatment with chemotherapeutics or radiation
- Emergency surgery
- Active participation in any another interventional or randomized study
- Participation in the current study within the past 30 days
Where it is running
- Brigham and Women's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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