Malnutrition Clinical Trial
— IDPNHDOfficial title:
Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients
Verified date | March 2016 |
Source | Fresenius Kabi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Federal Institute for Drugs and Medical Devices |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 140 |
Est. completion date | December 2010 |
Est. primary completion date | December 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - hemodialysis therapy more than 6 months - three times per week hemodialysis - albumin < 35 g/l - prealbumin < 250 mg/l - phase angle < 4,5° - SGA score grade B or C - informed consent Exclusion Criteria: - inadequate dialysis (Kt/V < 1,2) - chemotherapy or radiotherapy - cardiac pacemaker - acute bacterial infection - acute immunological disease - cancer disease - severe hepatic insufficiency - interferon therapy - HIV disease - severe diabetes mellitus |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Interneph e.V. Institute for Applied Nephrology | Aachen |
Lead Sponsor | Collaborator |
---|---|
Fresenius Kabi | Institute for Clinical Research |
Germany,
Mitch WE. Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest. 2002 Aug;110(4):437-9. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in prealbumin levels | 8 weeks | No | |
Secondary | Serum albumin, transferrin, nutritional status | 8 weeks | No |
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