Intradialytic Parenteral Nutrition in Hemodialysis Patients
Information source: Fresenius Kabi
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Malnutrition; Hemodialysis Patients
Intervention: glucose, amino acids, lipid solutions, L-Carnitine, trace elements (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Fresenius Kabi Official(s) and/or principal investigator(s):
Helmut Mann, Prof. Dr., Principal Investigator, Affiliation: Interneph e.V, Aachen
Overall contact:
Justinus Beer, Dr. rer. nat., Phone: 0049-6172-686, Ext: 8143, Email: Justinus.Beer@fresenius-kabi.com
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.
Clinical Details
Official title: Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients
Study design: Treatment, Randomized, Open Label, Parallel Assignment
Primary outcome: Change in prealbumin levels
Secondary outcome: Serum albumin, transferrin, nutritional status
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).
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Justinus Beer, Dr. rer. nat., Phone: 0049-6172-686, Ext: 8143, Email: Justinus.Beer@fresenius-kabi.com
Interneph e.V. Institute for Applied Nephrology, Aachen 52074, Germany; Recruiting
Helmut Mann, Prof. Dr., Phone: +49-241-872820, Email: helmut.mann@interneph.de
Roland Boehm, Dr., Sub-Investigator
Additional Information
Related publications: Mitch WE. Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest. 2002 Aug;110(4):437-9. No abstract available.
Starting date: July 2004
Ending date: November 2008
Last updated: October 31, 2008
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