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Intradialytic Parenteral Nutrition in Hemodialysis Patients (IDPNHD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00501956
First Posted: July 17, 2007
Last Update Posted: March 3, 2016
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.
Collaborator:
Institute for Clinical Research
Information provided by (Responsible Party):
Fresenius Kabi
  Purpose

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 Intervention Phase
Malnutrition Complication of Hemodialysis Drug: Intradialytic Parenteral Nutrition (IDPN) Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Fresenius Kabi:

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

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

Enrollment: 140
Study Start Date: July 2004
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
Germany
Interneph e.V. Institute for Applied Nephrology
Aachen, Germany, 52074
Sponsors and Collaborators
Fresenius Kabi
Institute for Clinical Research
Investigators
Principal Investigator: Helmut Mann, Prof. Dr. Interneph e.V, Aachen
  More Information

Publications:
Responsible Party: Fresenius Kabi
ClinicalTrials.gov Identifier: NCT00501956     History of Changes
Other Study ID Numbers: IDPN 24332
First Submitted: July 16, 2007
First Posted: July 17, 2007
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:
Malnutrition
Nutrition Disorders