Intradialytic Parenteral Nutrition in Hemodialysis Patients

Phase 4

Completed

• Conditions: Malnutrition; Complication of Hemodialysis
• Interventions: Drug: Intradialytic Parenteral Nutrition (IDPN)

• Registration Number: NCT00501956
• Lead Sponsor: Fresenius Kabi

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.

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 Timeline

• Study Start: 2004-07
• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-17
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intradialytic parenteral nutrition	Intradialytic Parenteral Nutrition (IDPN)	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.

Primary Outcome Measures

Name	Time	Method
Change in prealbumin levels	8 weeks

Secondary Outcome Measures

Name	Time	Method
Serum albumin, transferrin, nutritional status	8 weeks

Trial Locations

Locations (1)

Interneph e.V. Institute for Applied Nephrology; 🇩🇪 Aachen, Germany