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OpenTrials
Completed

NCT Number: NCT00501956

Intradialytic Parenteral Nutrition in 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Interneph e.V. Institute for Applied Nephrology

Aachen, 52074, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intradialytic Parenteral Nutrition (IDPN)

Drug

compounded IDPN, 3 x/week, 16 weeks intervention

Other names: Individually compounded parenteral nutrition

Primary outcomes

  1. Change in prealbumin levels

    Time frame: 8 weeks

Secondary outcomes

  1. Serum albumin, transferrin, nutritional status

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Fresenius Kabi

Industry

Collaborators

  • Institute for Clinical Research

Registry information

Official study title

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

Acronym: IDPNHD

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jul 17, 2007
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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