Intradialytic Parenteral Nutrition in Hemodialysis Patients

Study Overview
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Brief Summary
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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
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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).

Official Title
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Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients

Conditions
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Malnutrition, Complication of Hemodialysis

Intervention / Treatment
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* Drug: Intradialytic Parenteral Nutrition (IDPN)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intradialytic parenteral nutrition<br>Individually compounded intradialytic parenteral nutrition (IDPN) including glucose, amino acids, lipids, L-Carnitine, trace elements and water-soluable vitamins 3x / week over 16 weeks + 12 weeks postinterventional observation. | Drug: Intradialytic Parenteral Nutrition (IDPN)<br>* compounded IDPN, 3 x/week, 16 weeks intervention<br>* Other names: Individually compounded parenteral nutrition;|
| No Intervention: Control Group<br>Observation over 28 weeks (16 + 12 weeks). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in prealbumin levels |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum albumin, transferrin, nutritional status |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic renal replacement therapy, malnutrition anorexia, parenteral nutrition