Malnutrition Clinical Trial
Official title:
Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients
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.
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).
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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