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Intradialytic Parenteral Nutrition in Hemodialysis Patients (IDPNHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00501956
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : March 3, 2016
Sponsor:
Collaborator:
Institute for Clinical Research
Information provided by (Responsible Party):
Fresenius Kabi

Study Description
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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.


Condition or disease Intervention/treatment Phase
Malnutrition Complication of Hemodialysis Drug: Intradialytic Parenteral Nutrition (IDPN) Phase 4

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. Change in prealbumin levels [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Serum albumin, transferrin, nutritional status [ Time Frame: 8 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
Interneph e.V. Institute for Applied Nephrology
Aachen, Germany, 52074
Sponsors and Collaborators
Fresenius Kabi
Institute for Clinical Research
Investigators
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Principal Investigator: Helmut Mann, Prof. Dr. Interneph e.V, Aachen
More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT00501956    
Other Study ID Numbers: IDPN 24332
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
Keywords provided by Fresenius Kabi:
chronic renal replacement therapy
malnutrition anorexia
parenteral nutrition
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders