Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-26 @ 8:11 PM
Study NCT ID:
NCT00501956
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2007-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intradialytic Parenteral Nutrition in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D006963', 'term': 'Hyperphagia'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-01', 'studyFirstSubmitDate': '2007-07-16', 'studyFirstSubmitQcDate': '2007-07-16', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in prealbumin levels', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Serum albumin, transferrin, nutritional status', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['chronic renal replacement therapy', 'malnutrition anorexia', 'parenteral nutrition'], 'conditions': ['Malnutrition', 'Complication of Hemodialysis']}, 'referencesModule': {'references': [{'pmid': '12189236', 'type': 'BACKGROUND', 'citation': 'Mitch WE. Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest. 2002 Aug;110(4):437-9. doi: 10.1172/JCI16494. No abstract available.'}, {'pmid': '26708726', 'type': 'DERIVED', 'citation': 'Marsen TA, Beer J, Mann H; German IDPN-Trial group. Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial. Clin Nutr. 2017 Feb;36(1):107-117. doi: 10.1016/j.clnu.2015.11.016. Epub 2015 Dec 12.'}]}, 'descriptionModule': {'briefSummary': 'Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of malnutrition in these patients is dietetic counseling, additional enteral nutrition and occasionally drug therapy.\n\nIn cases where primary treatment of malnutrition is not effective, intradialytic parenteral nutrition (IDPN)during dialysis therapy may be administered. Using IDPN aminoacids, carbohydrates and fatty acids as well as vitamins and trace elements can be given to the patients.\n\nEffectiveness of IDPN has to be verified.', 'detailedDescription': '25% of hemodialysis patients who are treated for more than 5 years suffer from protein malnutrition. 7% have a protein catabolic rate less than 0,6 g/kgBW and day.\n\nThe conventional treatment of malnutrition include dietetic counseling, psychologic advice and giving additional oral nutrients.In many cases this kind of therapy is uneffective. If supplementary enteral nutrition is used, the additional intake of water has to be taken into consideration.\n\nIDPN is a mode of treatment by which disadvantages of enteral nutrition and fluid overload of the patients can be avoided.During each dialysis session nutrients can be given and additional water simultaneously can be removed by ultrafiltration.\n\nSome publications have shown that the catabolic state of the patients can be converted into an anabolic state. There are only small randomized studies showing the positive effect of IDPN.\n\nIn this german multicenter study malnourished hemodialysis patients are randomized into two groups. One group is treated with IDPN during each dialysis session for 16 weeks followed by 12 weeks of follow-up without IDPN. The control-group does not receive IDPN.\n\nThe parameters of metabolism are: Albumin, prealbumin, transferrin, phase angle alpha (bioimpedance), proteincatabolic rate (formal urea kinetics), BMI and subjective global assessment (SGA score).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hemodialysis therapy more than 6 months\n* three times per week hemodialysis\n* albumin \\< 35 g/l\n* prealbumin \\< 250 mg/l\n* phase angle \\< 4,5°\n* SGA score grade B or C\n* informed consent\n\nExclusion Criteria:\n\n* inadequate dialysis (Kt/V \\< 1,2)\n* chemotherapy or radiotherapy\n* cardiac pacemaker\n* acute bacterial infection\n* acute immunological disease\n* cancer disease\n* severe hepatic insufficiency\n* interferon therapy\n* HIV disease\n* severe diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT00501956', 'acronym': 'IDPNHD', 'briefTitle': 'Intradialytic Parenteral Nutrition in Hemodialysis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fresenius Kabi'}, 'officialTitle': 'Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'IDPN 24332'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intradialytic parenteral nutrition', 'description': 'Individually compounded intradialytic parenteral nutrition (IDPN) including glucose, amino acids, lipids, L-Carnitine, trace elements and water-soluable vitamins 3x / week over 16 weeks + 12 weeks postinterventional observation.', 'interventionNames': ['Drug: Intradialytic Parenteral Nutrition (IDPN)']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Observation over 28 weeks (16 + 12 weeks).'}], 'interventions': [{'name': 'Intradialytic Parenteral Nutrition (IDPN)', 'type': 'DRUG', 'otherNames': ['Individually compounded parenteral nutrition'], 'description': 'compounded IDPN, 3 x/week, 16 weeks intervention', 'armGroupLabels': ['Intradialytic parenteral nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Interneph e.V. Institute for Applied Nephrology', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Helmut Mann, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Interneph e.V, Aachen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fresenius Kabi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Institute for Clinical Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}