Status:
COMPLETED
Dietary Restriction in Vascular Surgery
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Vascular Diseases
Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Detailed Description
Hydrogen sulfide (H2S) has emerged as a critical gaseous signaling molecule with a role in multiple processes including ischemia-reperfusion (IR) injury, angiogenesis, intimal hyperplasia, and anti-in...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- • 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
- Exclusion Criteria
- 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
Exclusion
Key Trial Info
Start Date :
December 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04013412
Start Date
December 31 2018
End Date
March 31 2020
Last Update
September 25 2020
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115