Study Summary
This trial is testing whether nutritional supplements can improve the clinical status of vascular surgery patients with Critical Limb Ischemia.
Eligible Conditions
- Critical Limb Ischemia
- Malnutrition
- Nutritional Supplementation
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 1 Secondary · Reporting Duration: baseline and 30 days
baseline and 30 days
Change in C-reactive protein levels
Change in ERAS (Enhanced Recovery After Surgery) Malnutrition Screening Test (MST) Scores
Change in Hand grip strength
Prealbumin
Body Weight Changes
Change in transferrin levels
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Nutritional Supplement
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: Ensure Enlive Advanced Nutrition Shake · No Placebo Group · Phase < 1
Nutritional SupplementExperimental Group · 2 Interventions: Ensure Enlive Advanced Nutrition Shake, Ensure Surgery Immunonutrition Shake · Intervention Types: Drug, Drug
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 30 days
Who is running the clinical trial?
Boston Medical CenterLead Sponsor
358 Previous Clinical Trials
874,995 Total Patients Enrolled
Vascular & Endovascular Surgery SocietyUNKNOWN
AbbottIndustry Sponsor
731 Previous Clinical Trials
477,307 Total Patients Enrolled
Jeffrey J Siracuse, MDPrincipal InvestigatorBoston Medical Center
Eligibility Criteria
Age 18 - 99 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:References
- Lidder, P., S. Thomas, S. Fleming, K. Hosie, S. Shaw, and S. Lewis. 2013. “A Randomized Placebo Controlled Trial of Preoperative Carbohydrate Drinks and Early Postoperative Nutritional Supplement Drinks in Colorectal Surgery”. Colorectal Disease. Wiley. doi:10.1111/codi.12130.
- Hughes, Kakra, Christopher Boyd, Tolulope Oyetunji, Daniel Tran, David Chang, David Rose, Suryanarayan Siram, Edward Cornwell III, and Thomas Obisesan. 2014. “Racial/ethnic Disparities in Revascularization for Limb Salvage”. Vascular and Endovascular Surgery. SAGE Publications. doi:10.1177/1538574414543276.
- Makuuchi, R., N. Sugisawa, S. Kaji, M. Hikage, M. Tokunaga, Y. Tanizawa, E. Bando, T. Kawamura, and M. Terashima. 2017. “Enhanced Recovery After Surgery for Gastric Cancer and an Assessment of Preoperative Carbohydrate Loading”. European Journal of Surgical Oncology (EJSO). Elsevier BV. doi:10.1016/j.ejso.2016.07.140.
- Braga, Marco, Luca Gianotti, Luca Nespoli, Giovanni Radaelli, and Valerio Di Carlo. 2002. “Nutritional Approach in Malnourished Surgical Patients”. Archives of Surgery. American Medical Association (AMA). doi:10.1001/archsurg.137.2.174.
- Kubota, Keisuke, J. Kuroda, M. Yoshida, A. Okada, T. Deguchi, and M. Kitajima. 2014. “Preoperative Oral Supplementation Support in Patients with Esophageal Cancer”. The Journal of Nutrition, Health & Aging. Springer Science and Business Media LLC. doi:10.1007/s12603-014-0018-2.
- Short, V., C. Atkinson, A. R. Ness, S. Thomas, S. Burden, and E. Sutton. 2016. “Patient Experiences of Perioperative Nutrition Within an Enhanced Recovery After Surgery Programme for Colorectal Surgery: A Qualitative Study”. Colorectal Disease. Wiley. doi:10.1111/codi.13245.
- Leandro-Merhi, Vânia Aparecida, José Luiz Braga de Aquino, and José Francisco Sales Chagas. 2010. “Nutrition Status and Risk Factors Associated with Length of Hospital Stay for Surgical Patients”. Journal of Parenteral and Enteral Nutrition. Wiley. doi:10.1177/0148607110374477.
- Pirlich, Matthias, Tatjana Schütz, Kristina Norman, Sylvia Gastell, Heinrich Josef Lübke, Stephan C. Bischoff, Ulrich Bolder, et al.. 2006. “The German Hospital Malnutrition Study”. Clinical Nutrition. Elsevier BV. doi:10.1016/j.clnu.2006.03.005.
- Kobayashi, Daisuke, Kiyoshi Ishigure, Yoshinari Mochizuki, Hiroshi Nakayama, Mitsuru Sakai, Seiji Ito, Hiroshi Kojima, Masaki Kajikawa, Masahiko Ando, and Yasuhiro Kodera. 2016. “Multi-institutional Prospective Feasibility Study to Explore Tolerability and Efficacy of Oral Nutritional Supplements for Patients with Gastric Cancer Undergoing Gastrectomy (CCOG1301)”. Gastric Cancer. Springer Science and Business Media LLC. doi:10.1007/s10120-016-0668-3.
- Cerantola, Yannick, Fabian Grass, Alessandra Cristaudi, Nicolas Demartines, Markus Schäfer, and Martin Hübner. 2011. “Perioperative Nutrition in Abdominal Surgery: Recommendations and Reality”. Gastroenterology Research and Practice. Hindawi Limited. doi:10.1155/2011/739347.
- Braga, Marco, Luca Gianotti, Luca Nespoli, Giovanni Radaelli, and Valerio Di Carlo. 2002. “Nutritional Approach in Malnourished Surgical Patients”. Archives of Surgery. American Medical Association (AMA). doi:10.1001/archsurg.137.2.174.
- Pirlich, Matthias, Tatjana Schütz, Kristina Norman, Sylvia Gastell, Heinrich Josef Lübke, Stephan C. Bischoff, Ulrich Bolder, et al.. 2006. “The German Hospital Malnutrition Study”. Clinical Nutrition. Elsevier BV. doi:10.1016/j.clnu.2006.03.005.
- 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.
- 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.
- 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.
- 2018. "Nutrition in Patient With Critical Limb Ischemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03529019.
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