Nutrition in Patient With Critical Limb Ischemia

NCT03529019 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: H-37324
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition; Nutritional Supplements; Critical Limb Ischemia

Keywords

Enhanced Recovery After Surgery Protocol

Outcome Measures

Primary Outcomes (4)

• Change in serum albumin levels

  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

  baseline and 30 days

• Change in prealbumin levels

  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.

  baseline and 30 days

• Change in transferrin levels

  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.

  baseline and 30 days

• Change in C-reactive protein levels

  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.

  baseline and 30 days

Secondary Outcomes (1)

• Change in Hand grip strength

  baseline and 30 days

Other Outcomes (1)

• Change in ERAS (Enhanced Recovery After Surgery) Malnutrition Screening Test (MST) Scores

  baseline and 30 days

Study Arms (1)

Nutritional Supplement

EXPERIMENTAL

Administration of Ensure Surgery Immunonutrition Shake and ensure Enlive Advanced Nutrition Shake.

Drug: Ensure Surgery Immunonutrition Shake; Drug: Ensure Enlive Advanced Nutrition Shake

Interventions

Ensure Enlive Advanced Nutrition Shake DRUG

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. .

Nutritional Supplement

Ensure Surgery Immunonutrition Shake DRUG

An FDA approved nutritional supplement. Prepackaged product designed to be administered one week prior to and one week post surgical procedures.

Nutritional Supplement

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critical Limb Ischemia

You may not qualify if:

• Female patients who are pregnant or lactating
• Chronic Kidney Disease Stages 4 and 5
• Patients who are on dialysis

Sponsors & Collaborators

• Vascular & Endovascular Surgery Society: collaborator
• Boston Medical Center: lead
• Abbott: collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Leandro-Merhi VA, de Aquino JL, Sales Chagas JF. Nutrition status and risk factors associated with length of hospital stay for surgical patients. JPEN J Parenter Enteral Nutr. 2011 Mar;35(2):241-8. doi: 10.1177/0148607110374477. Epub 2010 Oct 22.

  PMID: 20971940 BACKGROUND

• Pirlich M, Schutz T, Norman K, Gastell S, Lubke HJ, Bischoff SC, Bolder U, Frieling T, Guldenzoph H, Hahn K, Jauch KW, Schindler K, Stein J, Volkert D, Weimann A, Werner H, Wolf C, Zurcher G, Bauer P, Lochs H. The German hospital malnutrition study. Clin Nutr. 2006 Aug;25(4):563-72. doi: 10.1016/j.clnu.2006.03.005. Epub 2006 May 15.

  PMID: 16698132 BACKGROUND

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Malnutrition

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Jeffrey J Siracuse, MD

  Boston Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey J Siracuse, MD

CONTACT

617-638-8488; Jeffrey.Siracuse@bmc.org

Myriam Castagne, B.S

CONTACT

617-638-8622; Myriam.Castagne@bmc.org

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Potential subjects with potential malnutrition and critical limb ischemia.

Study Record Dates

• First Submitted: April 13, 2018
• First Posted: May 18, 2018
• Study Start: October 2, 2018
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)