Nutrition in Patient With Critical Limb Ischemia



Status:Recruiting
Conditions:Food Studies, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Pharmacology / Toxicology
Healthy:No
Age Range:18 - 99
Updated:10/18/2018
Start Date:October 2, 2018
End Date:December 2020
Contact:Jeffrey J Siracuse, MD
Email:Jeffrey.Siracuse@bmc.org
Phone:617-638-8488

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Perioperative Nutritional Optimization in Patients With Critical Limb Ischemia

A prospective pilot study examining nutritional supplements among vascular surgery patients
with Critical Limb Ischemia (CLI). CLI patients have a high rate of malnutrition and has the
potential to benefit greatly from nutritional intervention. The investigators plan to
evaluate nutrition and functional status of patients by assessing objective lab values and
the use of the hand grip strength test. Providing perioperative nutritional supplements to
patients has potentially improved their nutritional status, which in turn may improve the
patient's clinical status after surgery.

Malnutrition continues to be a considerable public health issue in the United States and is
known to be associated with negative health outcomes. Surgeons and hospitals have adopted
preoperative nutritional screening and perioperative nutritional supplementation as best
practice for modern treatment of general surgery patients. Nutritional optimization has been
shown to improve outcomes in these patients and has become integrated as a key component of
the Enhanced Recovery After Surgery (ERAS) protocol. Although much progress has been made
towards optimizing perioperative nutritional status for general surgery patients in an effort
to improve surgical outcomes, there remains a dearth of information on the association
between nutritional status and health outcomes after vascular surgery interventions. Recent
research has found that up to 50% of general and gastrointestinal surgical patients suffered
from malnutrition in the preoperative phase. This finding has led to efforts to optimize the
nutritional status of general and gastrointestinal surgery patients in the perioperative
phase. Perioperative nutritional supplementation has been shown to reduce morbidity and
mortality in various subsets of surgical patients. This research has fallen short of
examining nutritional status and outcomes among vascular surgery patients. Published data in
this area has been limited to analyses of existing retrospective datasets. Additionally,
nutritional research that includes data from vascular surgery patients has been limited to an
examination of pre- and post-operative albumin levels in an attempt to find a correlation
between these levels and outcomes. Though this research is limited, it has shown that
vascular surgery patients with low (<3.5 g/dl) pre-operative albumin levels and critical limb
ischemia (CLI) are at increased risk for perioperative morbidity and mortality after lower
extremity bypass than vascular surgery patients with high pre-operative albumin levels (>3.5
g/dl). As serum albumin levels can be altered in the acute phase due to inflammation, this
research, while valuable, only represents a single component required for the assessment of
nutritional status.

Approximately 45.5% patients with CLI have been shown to have signs of preoperative
malnutrition when undergoing infrainguinal bypass. Malnutrition remains an underrepresented
area of perioperative management for vascular surgery patients. Research on the association
between nutritional supplementation and improved vascular surgery outcomes has the potential
to enhance the success of lower extremity interventions by validating an optimal adjunctive
medical therapy. Patients with CLI in general are at significantly higher risk for
perioperative morbidity and resource utilization when compared to other hospitalized
patients. Unlike many gastrointestinal surgery patients, these patients often do not have a
primary gastrointestinal pathology contributing to their malnutrition; more likely, it may be
the result of their comorbidities and an overall failure to thrive. Perioperative nutritional
supplementation has the potential to improve the nutritional status of these patients and
ultimately improve outcomes. Yet, to date, no prospective trial of nutritional
supplementation in CLI patients has been performed.

A multidisciplinary team including nutritionists, vascular surgeons, and surgical critical
care surgeons with expertise in perioperative nutrition research has been assembled to
conduct a pilot research study examining the impact of nutritional supplementation on
vascular surgery outcomes.

Inclusion Criteria:

- Critical Limb Ischemia

Exclusion Criteria:

- Female patients who are pregnant or lactating

- Chronic Kidney Disease Stages 4 and 5

- Patients who are on dialysis
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Boston, Massachusetts 02118
Phone: 617-638-8488
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