Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT00559520
Status:
COMPLETED
Last Update Posted:
2011-12-09
First Post:
2007-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-08', 'studyFirstSubmitDate': '2007-11-14', 'studyFirstSubmitQcDate': '2007-11-15', 'lastUpdatePostDateStruct': {'date': '2011-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-11-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight', 'timeFrame': 'before surgery, five days and thirty days after surgery'}, {'measure': 'Arisen of an infectious complication', 'timeFrame': 'during the period of 30 days following the surgery'}, {'measure': 'Arisen of non infectious complication', 'timeFrame': 'during the period of 30 days following the surgery'}], 'secondaryOutcomes': [{'measure': 'Primary and secondary permeability', 'timeFrame': 'at 5 and 30 days after surgery'}, {'measure': 'Pain', 'timeFrame': 'at 5 and 30 days after surgery'}, {'measure': 'Healing', 'timeFrame': 'at 5 and 30 days after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patients', 'Suffering', 'Undernutrition', 'Requiring', 'Vascular', 'Surgery'], 'conditions': ['Undernutrition']}, 'referencesModule': {'references': [{'pmid': '8598437', 'type': 'BACKGROUND', 'citation': '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': '12122555', 'type': 'BACKGROUND', 'citation': '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': '66485', 'type': 'BACKGROUND', 'citation': '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': '7091909', 'type': 'BACKGROUND', 'citation': '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': '416704', 'type': 'BACKGROUND', 'citation': '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': '3138447', 'type': 'BACKGROUND', 'citation': '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': '12055582', 'type': 'BACKGROUND', 'citation': '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': '11028551', 'type': 'BACKGROUND', 'citation': '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': '3102782', 'type': 'BACKGROUND', 'citation': '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': '9284874', 'type': 'BACKGROUND', 'citation': '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': '11103653', 'type': 'BACKGROUND', 'citation': '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': '11588077', 'type': 'BACKGROUND', 'citation': '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': '12443751', 'type': 'BACKGROUND', 'citation': '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': '9684265', 'type': 'BACKGROUND', 'citation': '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': '2232107', 'type': 'BACKGROUND', 'citation': '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': '10096109', 'type': 'BACKGROUND', 'citation': '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': '10628629', 'type': 'BACKGROUND', 'citation': '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': '11509059', 'type': 'BACKGROUND', 'citation': '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': '10203078', 'type': 'BACKGROUND', 'citation': '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': '7874893', 'type': 'BACKGROUND', 'citation': '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': '11551575', 'type': 'BACKGROUND', 'citation': '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': '7486330', 'type': 'BACKGROUND', 'citation': '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': '3382352', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The role of preoperative oral immunonutrition in major vascular surgery.\n\nThe 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.\n\nThis group was compared to a control group.\n\nSecondary 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intervention planned since at least 5 days before surgery\n* Duration of hospitalization of at least 5 days\n\nExclusion Criteria:\n\n* Pregnant or lactating woman\n* Patient with severe renal insufficiency\n* Patient under 18 years old\n* Patient infected with HIV,hépatitis B or C'}, 'identificationModule': {'nctId': 'NCT00559520', 'briefTitle': 'The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'The Role of Preoperative Oral Immunonutrition in Major Vascular Surgery', 'orgStudyIdInfo': {'id': 'PHRC 2004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Impact', 'description': 'patient receiving 3 drinks "Impact" a day during 5 days before surgery', 'interventionNames': ['Dietary Supplement: Impact']}, {'type': 'EXPERIMENTAL', 'label': 'Oral Impact', 'description': 'Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery', 'interventionNames': ['Dietary Supplement: Oral Impact']}], 'interventions': [{'name': 'Impact', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patient receiving 3 drinks "Impact" a day during 5 days before surgery', 'armGroupLabels': ['Impact']}, {'name': 'Oral Impact', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patient receiving 3 drinks "Oral Impact" a day during 5 days before surgery', 'armGroupLabels': ['Oral Impact']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'CHU de NICE, Department of Vascular Surgery', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Michel BATT, Professeur', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Vascular Surgery, CHU de NICE'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}