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Intradialytic Parenteral Nutrition in Hemodialysis Patients (IDPNHD)

This study has been completed.
Sponsor:
Collaborator:
Institute for Clinical Research
Information provided by (Responsible Party):
Fresenius Kabi
ClinicalTrials.gov Identifier:
NCT00501956
First received: July 16, 2007
Last updated: September 21, 2011
Last verified: September 2010

July 16, 2007
September 21, 2011
July 2004
December 2010   (final data collection date for primary outcome measure)
Change in prealbumin levels [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00501956 on ClinicalTrials.gov Archive Site
Serum albumin, transferrin, nutritional status [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Intradialytic Parenteral Nutrition in Hemodialysis Patients
Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients

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.

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).

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Malnutrition
  • Hemodialysis Patients
Drug: glucose, amino acids, lipid solutions, L-Carnitine, trace elements
compounded IDPN, 3 x/week, 16 weeks intervention
  • Experimental: IDPN
    patients receive parenteral nutrition
    Intervention: Drug: glucose, amino acids, lipid solutions, L-Carnitine, trace elements
  • No Intervention: Control
Mitch WE. Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest. 2002 Aug;110(4):437-9. No abstract available.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00501956
IDPN 24332
No
Fresenius Kabi
Fresenius Kabi
Institute for Clinical Research
Principal Investigator: Helmut Mann, Prof. Dr. Interneph e.V, Aachen
Fresenius Kabi
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP