Intradialytic Parenteral Nutrition in Hemodialysis Patients (IDPNHD)
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|ClinicalTrials.gov Identifier: NCT00501956|
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : March 3, 2016
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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.
|Condition or disease||Intervention/treatment||Phase|
|Malnutrition Complication of Hemodialysis||Drug: Intradialytic Parenteral Nutrition (IDPN)||Phase 4|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: Intradialytic parenteral nutrition
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)
compounded IDPN, 3 x/week, 16 weeks intervention
Other Name: Individually compounded parenteral nutrition
No Intervention: Control Group
Observation over 28 weeks (16 + 12 weeks).
- Change in prealbumin levels [ Time Frame: 8 weeks ]
- Serum albumin, transferrin, nutritional status [ Time Frame: 8 weeks ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00501956
|Interneph e.V. Institute for Applied Nephrology|
|Aachen, Germany, 52074|
|Principal Investigator:||Helmut Mann, Prof. Dr.||Interneph e.V, Aachen|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Fresenius Kabi|
|Other Study ID Numbers:||
|First Posted:||July 17, 2007 Key Record Dates|
|Last Update Posted:||March 3, 2016|
|Last Verified:||March 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
chronic renal replacement therapy