Intradialytic Parenteral Nutrition in Hemodialysis Patients

Malnutrition Clinical Trial

— IDPNHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00501956
• Other study ID #: IDPN 24332
• Status: Completed
• Phase: Phase 4
• First received: July 16, 2007
• Last updated: March 1, 2016
• Start date: July 2004
• Est. completion date: December 2010

Study information

• Verified date: March 2016
• Source: Fresenius Kabi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication of Hemodialysis
• Malnutrition

Intervention

Drug:
• Intradialytic Parenteral Nutrition (IDPN)
compounded IDPN, 3 x/week, 16 weeks intervention

Locations

Country	Name	City	State
Germany	Interneph e.V. Institute for Applied Nephrology	Aachen

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Kabi	Institute for Clinical Research

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Mitch WE. Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest. 2002 Aug;110(4):437-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in prealbumin levels		8 weeks	No
Secondary	Serum albumin, transferrin, nutritional status		8 weeks	No