The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery

NCT00559520 | Completed Phase 4

• 1 other identifier: PHRC 2004
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The role of preoperative oral immunonutrition in major vascular surgery. The mean purpose of this study was to determine the prevalence of post-operative infection complications after major vascular surgery in group of patients with preoperative oral immunonutrition. This group was compared to a control group. Secondary purpose was to evaluate the effect of preoperative oral immunonutrition on postoperative mortality (30 days), the medium length of stay in the hospital and the cost of treatment in the two groups

Conditions

Undernutrition

Keywords

Patients; Suffering; Undernutrition; Requiring; Vascular; Surgery

Outcome Measures

Primary Outcomes (3)

• Weight

  before surgery, five days and thirty days after surgery

• Arisen of an infectious complication

  during the period of 30 days following the surgery

• Arisen of non infectious complication

  during the period of 30 days following the surgery

Secondary Outcomes (3)

• Primary and secondary permeability

  at 5 and 30 days after surgery

• Pain

  at 5 and 30 days after surgery

• Healing

  at 5 and 30 days after surgery

Study Arms (2)

Impact

ACTIVE COMPARATOR

patient receiving 3 drinks "Impact" a day during 5 days before surgery

Dietary Supplement: Impact

Oral Impact

EXPERIMENTAL

Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery

Dietary Supplement: Oral Impact

Interventions

Impact DIETARY_SUPPLEMENT

Patient receiving 3 drinks "Impact" a day during 5 days before surgery

Impact

Oral Impact DIETARY_SUPPLEMENT

Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery

Oral Impact

Eligibility Criteria

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

You may qualify if:

• Intervention planned since at least 5 days before surgery
• Duration of hospitalization of at least 5 days

You may not qualify if:

• Pregnant or lactating woman
• Patient with severe renal insufficiency
• Patient under 18 years old
• Patient infected with HIV,hépatitis B or C

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead
• Novartis: collaborator

Study Sites (1)

CHU de NICE, Department of Vascular Surgery

Nice, 06000, France

Location

Related Publications (23)

• Gallagher-Allred CR, Voss AC, Finn SC, McCamish MA. Malnutrition and clinical outcomes: the case for medical nutrition therapy. J Am Diet Assoc. 1996 Apr;96(4):361-6, 369; quiz 367-8. doi: 10.1016/s0002-8223(96)00099-5.

  PMID: 8598437 BACKGROUND

• Bauer J, Capra S, Ferguson M. Use of the scored Patient-Generated Subjective Global Assessment (PG-SGA) as a nutrition assessment tool in patients with cancer. Eur J Clin Nutr. 2002 Aug;56(8):779-85. doi: 10.1038/sj.ejcn.1601412.

  PMID: 12122555 BACKGROUND

• Hill GL, Blackett RL, Pickford I, Burkinshaw L, Young GA, Warren JV, Schorah CJ, Morgan DB. Malnutrition in surgical patients. An unrecognised problem. Lancet. 1977 Mar 26;1(8013):689-92. doi: 10.1016/s0140-6736(77)92127-4.

  PMID: 66485 BACKGROUND

• Arora NS, Rochester DF. Respiratory muscle strength and maximal voluntary ventilation in undernourished patients. Am Rev Respir Dis. 1982 Jul;126(1):5-8. doi: 10.1164/arrd.1982.126.1.5.

  PMID: 7091909 BACKGROUND

• Heymsfield SB, Bethel RA, Ansley JD, Gibbs DM, Felner JM, Nutter DO. Cardiac abnormalities in cachectic patients before and during nutritional repletion. Am Heart J. 1978 May;95(5):584-94. doi: 10.1016/0002-8703(78)90300-9. No abstract available.

  PMID: 416704 BACKGROUND

• Reilly JJ Jr, Hull SF, Albert N, Waller A, Bringardener S. Economic impact of malnutrition: a model system for hospitalized patients. JPEN J Parenter Enteral Nutr. 1988 Jul-Aug;12(4):371-6. doi: 10.1177/0148607188012004371.

  PMID: 3138447 BACKGROUND

• Gianotti L, Braga M, Nespoli L, Radaelli G, Beneduce A, Di Carlo V. A randomized controlled trial of preoperative oral supplementation with a specialized diet in patients with gastrointestinal cancer. Gastroenterology. 2002 Jun;122(7):1763-70. doi: 10.1053/gast.2002.33587.

  PMID: 12055582 BACKGROUND

• Gianotti L, Braga M, Frei A, Greiner R, Di Carlo V. Health care resources consumed to treat postoperative infections: cost saving by perioperative immunonutrition. Shock. 2000 Sep;14(3):325-30. doi: 10.1097/00024382-200014030-00015.

  PMID: 11028551 BACKGROUND

• Robinson G, Goldstein M, Levine GM. Impact of nutritional status on DRG length of stay. JPEN J Parenter Enteral Nutr. 1987 Jan-Feb;11(1):49-51. doi: 10.1177/014860718701100149.

  PMID: 3102782 BACKGROUND

• Chima CS, Barco K, Dewitt ML, Maeda M, Teran JC, Mullen KD. Relationship of nutritional status to length of stay, hospital costs, and discharge status of patients hospitalized in the medicine service. J Am Diet Assoc. 1997 Sep;97(9):975-8; quiz 979-80. doi: 10.1016/S0002-8223(97)00235-6.

  PMID: 9284874 BACKGROUND

• Braunschweig C, Gomez S, Sheean PM. Impact of declines in nutritional status on outcomes in adult patients hospitalized for more than 7 days. J Am Diet Assoc. 2000 Nov;100(11):1316-22; quiz 1323-4. doi: 10.1016/S0002-8223(00)00373-4.

  PMID: 11103653 BACKGROUND

• Lewis SJ, Egger M, Sylvester PA, Thomas S. Early enteral feeding versus "nil by mouth" after gastrointestinal surgery: systematic review and meta-analysis of controlled trials. BMJ. 2001 Oct 6;323(7316):773-6. doi: 10.1136/bmj.323.7316.773.

  PMID: 11588077 BACKGROUND

• Spark JI, Robinson JM, Gallavin L, Gough MJ, Homer-Vanniasinkam S, Kester RC, Scott DJ. Patients with chronic critical limb ischaemia have reduced total antioxidant capacity and impaired nutritional status. Eur J Vasc Endovasc Surg. 2002 Dec;24(6):535-9. doi: 10.1053/ejvs.2002.1755.

  PMID: 12443751 BACKGROUND

• Evoy D, Lieberman MD, Fahey TJ 3rd, Daly JM. Immunonutrition: the role of arginine. Nutrition. 1998 Jul-Aug;14(7-8):611-7. doi: 10.1016/s0899-9007(98)00005-7.

  PMID: 9684265 BACKGROUND

• Kirk SJ, Barbul A. Role of arginine in trauma, sepsis, and immunity. JPEN J Parenter Enteral Nutr. 1990 Sep-Oct;14(5 Suppl):226S-229S. doi: 10.1177/014860719001400514. No abstract available.

  PMID: 2232107 BACKGROUND

• Wu D, Meydani SN. n-3 polyunsaturated fatty acids and immune function. Proc Nutr Soc. 1998 Nov;57(4):503-9. doi: 10.1079/pns19980074.

  PMID: 10096109 BACKGROUND

• Beale RJ, Bryg DJ, Bihari DJ. Immunonutrition in the critically ill: a systematic review of clinical outcome. Crit Care Med. 1999 Dec;27(12):2799-805. doi: 10.1097/00003246-199912000-00032.

  PMID: 10628629 BACKGROUND

• Heyland DK, Novak F, Drover JW, Jain M, Su X, Suchner U. Should immunonutrition become routine in critically ill patients? A systematic review of the evidence. JAMA. 2001 Aug 22-29;286(8):944-53. doi: 10.1001/jama.286.8.944.

  PMID: 11509059 BACKGROUND

• Heys SD, Walker LG, Smith I, Eremin O. Enteral nutritional supplementation with key nutrients in patients with critical illness and cancer: a meta-analysis of randomized controlled clinical trials. Ann Surg. 1999 Apr;229(4):467-77. doi: 10.1097/00000658-199904000-00004.

  PMID: 10203078 BACKGROUND

• Bower RH, Cerra FB, Bershadsky B, Licari JJ, Hoyt DB, Jensen GL, Van Buren CT, Rothkopf MM, Daly JM, Adelsberg BR. Early enteral administration of a formula (Impact) supplemented with arginine, nucleotides, and fish oil in intensive care unit patients: results of a multicenter, prospective, randomized, clinical trial. Crit Care Med. 1995 Mar;23(3):436-49. doi: 10.1097/00003246-199503000-00006.

  PMID: 7874893 BACKGROUND

• Tepaske R, Velthuis H, Oudemans-van Straaten HM, Heisterkamp SH, van Deventer SJ, Ince C, Eysman L, Kesecioglu J. Effect of preoperative oral immune-enhancing nutritional supplement on patients at high risk of infection after cardiac surgery: a randomised placebo-controlled trial. Lancet. 2001 Sep 1;358(9283):696-701. doi: 10.1016/s0140-6736(01)05836-6.

  PMID: 11551575 BACKGROUND

• Melchior JC. [How to assess preoperative nutritional status?]. Ann Fr Anesth Reanim. 1995;14 Suppl 2:19-26. doi: 10.1016/s0750-7658(95)80098-0. French.

  PMID: 7486330 BACKGROUND

• Johnson JA, Cogbill TH, Strutt PJ, Gundersen AL. Wound complications after infrainguinal bypass. Classification, predisposing factors, and management. Arch Surg. 1988 Jul;123(7):859-62. doi: 10.1001/archsurg.1988.01400310073012.

  PMID: 3382352 BACKGROUND

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Michel BATT, Professeur

  Department of Vascular Surgery, CHU de NICE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SCREENING
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2007
• First Posted: November 16, 2007
• Study Start: February 1, 2002
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 9, 2011

Record last verified: 2011-12

Locations

FR (1)