Nutrition in Patient With Critical Limb Ischemia

Official title

Perioperative Nutritional Optimization in Patients With Critical Limb Ischemia

Overview

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.

Detailed description

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.

Interventions

• Drug Ensure Surgery Immunonutrition Shake
  An FDA approved nutritional supplement. Prepackaged product designed to be administered one week prior to and one week post surgical procedures.
• Drug Ensure Enlive Advanced Nutrition Shake
  An FDA approved nutritional supplement. Prepackaged product designed to be administered 2 weeks prior to and 2 weeks post surgical procedure for a period of one week. .

Primary outcome measures

• Change in serum albumin levels [Time frame: baseline and 30 days]
• Change in prealbumin levels [Time frame: baseline and 30 days]
• Change in transferrin levels [Time frame: baseline and 30 days]
• Change in C-reactive protein levels [Time frame: baseline and 30 days]

Secondary outcome measures (1)

• Change in Hand grip strength [Time frame: baseline and 30 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 1 center

• Boston Medical Center — Boston

Publications

• Kubota K, Kuroda J, Yoshida M, Okada A, Deguchi T, Kitajima M. Preoperative oral supplementation support in patients with esophageal cancer. J Nutr Health Aging. 2014 Apr;18(4):437-40. doi: 10.1007/s12603-014-0018-2. PMID 24676327
• Lidder P, Thomas S, Fleming S, Hosie K, Shaw S, Lewis S. A randomized placebo controlled trial of preoperative carbohydrate drinks and early postoperative nutritional supplement drinks in colorectal surgery. Colorectal Dis. 2013 Jun;15(6):737-45. doi: 10.1111/codi.12130. PMID 23406311
• Kobayashi D, Ishigure K, Mochizuki Y, Nakayama H, Sakai M, Ito S, Kojima H, Kajikawa M, Ando M, Kodera Y. Multi-institutional prospective feasibility study to explore tolerability and efficacy of oral nutritional supplements for patients with gastric cancer undergoing gastrectomy (CCOG1301). Gastric Cancer. 2017 Jul;20(4):718-727. doi: 10.1007/s10120-016-0668-3. Epub 2016 Nov 24. PMID 27885538
• Short V, Atkinson C, Ness AR, Thomas S, Burden S, Sutton E. Patient experiences of perioperative nutrition within an Enhanced Recovery After Surgery programme for colorectal surgery: a qualitative study. Colorectal Dis. 2016 Feb;18(2):O74-80. doi: 10.1111/codi.13245. PMID 26682875
• Makuuchi R, Sugisawa N, Kaji S, Hikage M, Tokunaga M, Tanizawa Y, Bando E, Kawamura T, Terashima M. Enhanced recovery after surgery for gastric cancer and an assessment of preoperative carbohydrate loading. Eur J Surg Oncol. 2017 Jan;43(1):210-217. doi: 10.1016/j.ejso.2016.07.140. Epub 2016 Aug 10. PMID 27554250
• Braga M, Gianotti L, Nespoli L, Radaelli G, Di Carlo V. Nutritional approach in malnourished surgical patients: a prospective randomized study. Arch Surg. 2002 Feb;137(2):174-80. doi: 10.1001/archsurg.137.2.174. PMID 11822956
• Hughes K, Boyd C, Oyetunji T, Tran D, Chang D, Rose D, Siram S, Cornwell E 3rd, Obisesan T. Racial/ethnic disparities in revascularization for limb salvage: an analysis of the National Surgical Quality Improvement Program database. Vasc Endovascular Surg. 2014 Jul-Aug;48(5-6):402-5. doi: 10.1177/1538574414543276. Epub 2014 Jul 30. PMID 25080452
• Cerantola Y, Grass F, Cristaudi A, Demartines N, Schafer M, Hubner M. Perioperative nutrition in abdominal surgery: recommendations and reality. Gastroenterol Res Pract. 2011;2011:739347. doi: 10.1155/2011/739347. Epub 2011 May 22. PMID 21687620

Identifiers

NCT: NCT03529019 · H-37324

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗