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| Sponsor: | Fresenius Kabi |
|---|---|
| Collaborator: |
Institute for Clinical Research |
| Information provided by (Responsible Party): | Fresenius Kabi |
| ClinicalTrials.gov Identifier: | NCT00501956 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malnutrition Hemodialysis Patients |
Drug: glucose, amino acids, lipid solutions, L-Carnitine, trace elements |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients |
| Enrollment: | 140 |
| Study Start Date: | July 2004 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: IDPN
patients receive parenteral nutrition
|
Drug: glucose, amino acids, lipid solutions, L-Carnitine, trace elements
compounded IDPN, 3 x/week, 16 weeks intervention
|
| No Intervention: Control |
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Interneph e.V. Institute for Applied Nephrology | |
| Aachen, Germany, 52074 | |
| Principal Investigator: | Helmut Mann, Prof. Dr. | Interneph e.V, Aachen |
More Information
| Responsible Party: | Fresenius Kabi |
| ClinicalTrials.gov Identifier: | NCT00501956 History of Changes |
| Other Study ID Numbers: | IDPN 24332 |
| Study First Received: | July 16, 2007 |
| Last Updated: | September 21, 2011 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
chronic renal replacement therapy malnutrition anorexia parenteral nutrition |
|
Malnutrition Nutrition Disorders Carnitine Micronutrients Trace Elements |
Vitamin B Complex Vitamins Growth Substances Physiological Effects of Drugs Pharmacologic Actions |
