drugset / Trial / NCT03529019
Nutrition in Patient With Critical Limb Ischemia
Phase 0
Recruiting
30 enrolled
Boston Medical Center
Abbott · collabVascular & Endovascular Surgery Society · collab
NaSingle-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2018-10-02
- Primary completion
- 2026-09
- Completion
- 2026-09
Publications
- Background 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ensure Enlive Advanced Nutrition Shake | Other / unclassified | — | — |
| Subject | Ensure Surgery Immunonutrition Shake | Other / unclassified | — | — |