Intradialytic Parenteral Nutrition in Hemodialysis Patients (IDPNHD)
| Tracking Information | |||||
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| First Received Date ICMJE | July 16, 2007 | ||||
| Last Updated Date | September 21, 2011 | ||||
| Start Date ICMJE | July 2004 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Change in prealbumin levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00501956 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Serum albumin, transferrin, nutritional status [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intradialytic Parenteral Nutrition in Hemodialysis Patients | ||||
| Official Title ICMJE | Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients | ||||
| Brief Summary | 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. In 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. Effectiveness of IDPN has to be verified. |
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| Detailed Description | 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. The 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. IDPN 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. Some 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. In 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. The parameters of metabolism are: Albumin, prealbumin, transferrin, phase angle alpha (bioimpedance), proteincatabolic rate (formal urea kinetics), BMI and subjective global assessment (SGA score). |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 4 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: glucose, amino acids, lipid solutions, L-Carnitine, trace elements
compounded IDPN, 3 x/week, 16 weeks intervention |
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| Study Arm (s) |
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| Publications * | Mitch WE. Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest. 2002 Aug;110(4):437-9. No abstract available. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 140 | ||||
| Completion Date | December 2010 | ||||
| Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00501956 | ||||
| Other Study ID Numbers ICMJE | IDPN 24332 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Fresenius Kabi | ||||
| Study Sponsor ICMJE | Fresenius Kabi | ||||
| Collaborators ICMJE | Institute for Clinical Research | ||||
| Investigators ICMJE |
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| Information Provided By | Fresenius Kabi | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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