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Nutrition in Patient With Critical Limb Ischemia (NutriVasc)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03529019
Recruitment Status : Suspended (Curretly suspended due to Covid-19 policies.)
First Posted : May 18, 2018
Last Update Posted : May 1, 2020
Sponsor:
Collaborators:
Vascular & Endovascular Surgery Society
Abbott
Information provided by (Responsible Party):
Boston Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Malnutrition Nutritional Supplements Drug: Ensure Surgery Immunonutrition Shake Drug: Ensure Enlive Advanced Nutrition Shake Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Potential subjects with potential malnutrition and critical limb ischemia.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Perioperative Nutritional Optimization in Patients With Critical Limb Ischemia
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : February 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nutritional Supplement
Administration of Ensure Surgery Immunonutrition Shake and ensure Enlive Advanced Nutrition Shake.
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 :
  1. Change in serum albumin levels [ Time Frame: baseline and 30 days ]
    Albumin is a carbohydrate-free protein, which constitutes 55% to 65% of total plasma protein. Albumin results can reflect the nutritional status of the body and other problems with the kidney or liver. A normal albumin range is 3.4 to 5.4 g/dL. Albumin levels will be tested on blood samples on each participant obtained at baseline and 30 days after nutritional supplementation. Lower albumin levels are associated with malnutrition

  2. Change in prealbumin levels [ Time Frame: baseline and 30 days ]
    Prealbumin is a protein produced by the liver and levels can reflect nutritional status. Normal results for a prealbumin blood test for adults are 15 to 36 milligrams per deciliter (mg/dL). Prealbumin levels will be tested on blood samples on each participant obtained at baseline and 30 days after nutritional supplementation. Lower levels of prealbumin are associated with malnutrition.

  3. Change in transferrin levels [ Time Frame: baseline and 30 days ]
    Transferrin is the main protein in the blood that binds to iron and transports it throughout the body. The normal range for transferrin is 170 to 370 mg/dl. Transferrin levels will be tested on blood samples on each participant obtained at baseline and 30 days after nutritional supplementation. Transferrin levels rise with iron deficiency and fall in cases of iron overload.

  4. Change in C-reactive protein levels [ Time Frame: baseline and 30 days ]
    C-reactive protein (CRP) is a substance produced by the liver that increases in the presence of inflammation in the body. C-reactive protein levels will be tested on blood samples on each participant obtained at baseline and 30 days after nutritional supplementation. Lower levels are favorable.


Secondary Outcome Measures :
  1. Change in Hand grip strength [ Time Frame: baseline and 30 days ]
    A hand dynamometer will be used to measure hand grip strength. Higher values are favorable.


Other Outcome Measures:
  1. Change in ERAS (Enhanced Recovery After Surgery) Malnutrition Screening Test (MST) Scores [ Time Frame: baseline and 30 days ]
    The ERAS Malnutrition Screening Test (MST) is a 3 question survey used to evaluate patient's nutritional status. The 3 questions ask about recent weight loss without trying, amount of the weight loss, and whether eating poorly because of a decreased appetite. Scores of 2 or greater indicate risk of malnutrition. Lower scores are favorable.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529019


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston Medical Center
Vascular & Endovascular Surgery Society
Abbott
Investigators
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Principal Investigator: Jeffrey J Siracuse, MD Boston Medical Center
Publications:

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Responsible Party: Boston Medical Center
ClinicalTrials.gov Identifier: NCT03529019    
Other Study ID Numbers: H-37324
First Posted: May 18, 2018    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Boston Medical Center:
Enhanced Recovery After Surgery Protocol
Additional relevant MeSH terms:
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Malnutrition
Ischemia
Pathologic Processes
Nutrition Disorders