Clinical trial NCT00501956: Intradialytic Parenteral Nutrition in Hemodialysis Patients
Official title: Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malnutrition
Complication of Hemodialysis
Keywords: chronic renal replacement therapy
malnutrition anorexia
parenteral nutrition
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
Collaborators: name: Institute for Clinical Research
First posted: 2007-07-17
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Change in prealbumin levels
timeFrame: 8 weeks
Secondary outcomes:
measure: Serum albumin, transferrin, nutritional status
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Interneph e.V. Institute for Applied Nephrology
Study officials:
affiliation: Interneph e.V, Aachen
name: Helmut Mann, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mitch WE. Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest. 2002 Aug;110(4):437-9. doi: 10.1172/JCI16494. No abstract available.
citation: Marsen TA, Beer J, Mann H; German IDPN-Trial group. Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial. Clin Nutr. 2017 Feb;36(1):107-117. doi: 10.1016/j.clnu.2015.11.016. Epub 2015 Dec 12.