Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2026-02-09 @ 2:22 AM
Study NCT ID:
NCT00314834
Status:
TERMINATED
Last Update Posted:
2006-04-17
First Post:
2006-04-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 204}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2001-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-03', 'completionDateStruct': {'date': '2004-12'}, 'lastUpdateSubmitDate': '2006-04-14', 'studyFirstSubmitDate': '2006-04-14', 'studyFirstSubmitQcDate': '2006-04-14', 'lastUpdatePostDateStruct': {'date': '2006-04-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-04-17', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mortality'}], 'secondaryOutcomes': [{'measure': 'hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin'}]}, 'conditionsModule': {'keywords': ['hemodialysis', 'intradialytic parenteral nutrition', 'oral supplementation', 'survival', 'hospitalization', 'serum albumin', 'prealbumin', 'transthyretin'], 'conditions': ['Hemodialysis', 'Malnutrition']}, 'referencesModule': {'references': [{'pmid': '17656473', 'type': 'DERIVED', 'citation': 'Cano NJ, Fouque D, Roth H, Aparicio M, Azar R, Canaud B, Chauveau P, Combe C, Laville M, Leverve XM; French Study Group for Nutrition in Dialysis. Intradialytic parenteral nutrition does not improve survival in malnourished hemodialysis patients: a 2-year multicenter, prospective, randomized study. J Am Soc Nephrol. 2007 Sep;18(9):2583-91. doi: 10.1681/ASN.2007020184. Epub 2007 Jul 26.'}]}, 'descriptionModule': {'briefSummary': 'IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score', 'detailedDescription': 'IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score.\n\nPatient eligibility: adult patients ≤ 82 y with HD vintage \\> 6 mo. and 2 of the following malnutrition criteria: BMI ≤ 20 kg/m2, BW loss/6 mo. ≥ 10%, serum albumin ≤ 35 g/L, prealbumin ≤ 300 mg/L.\n\nRecruitment: patients in 38 HD units from January 2001 to December 2002 Study protocol. Patients are randomized into 2 groups: IDPN group, given IDPN during one year, and control group. For ethical reasons, the 2 groups are given oral supplementation during the same period.\n\nFollow-up: two years after start of nutritional therapy. Study end: December 31, 2004. Final results will be available in early 2005.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '82 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age between 18 and 82 years\n* hemodialysis vintage more than 6 months\n* two of the following markers of malnutrition:\n* body mass index (BMI) \\<= 20 kg/m2\n* body weight loss within 6 months \\>= 10 percent\n* serum albumin \\<= 35 g/L\n* prealbumin \\<= 300 mg/L\n\nExclusion Criteria:\n\n* weekly dialysis time \\< 12 h\n* urea Kt/V index \\< 1.2\n* serum albumin \\> 38 g/L\n* prealbumin \\> 330 mg/L\n* hypertriglyceridemia \\> 2.5 mmol/L\n* associated comorbidities compromising the one-year survival\n* treatment by oral, enteral or parenteral feeding during the last 3 months\n* hospitalization at time of randomization'}, 'identificationModule': {'nctId': 'NCT00314834', 'briefTitle': 'Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'EZUS-LYON 1'}, 'officialTitle': 'Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'EZUS-A1244'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intradialytic parenteral nutrition', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Noel JM Cano, MD-PhD', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EZUS-LYON 1', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'Societe Francaise de Dialyse', 'class': 'UNKNOWN'}, {'name': 'Societe Francophone de Nutrition Enterale et Parenterale', 'class': 'OTHER'}]}}}