Intradialytic Parenteral Nutrition in Hemodialysis Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2010-12-31

Brief Summary

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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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Detailed Description

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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).

Conditions

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Malnutrition Complication of Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Intradialytic Parenteral Nutrition (IDPN)

Intervention Type DRUG

compounded IDPN, 3 x/week, 16 weeks intervention

Control Group

Observation over 28 weeks (16 + 12 weeks).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intradialytic Parenteral Nutrition (IDPN)

compounded IDPN, 3 x/week, 16 weeks intervention

Intervention Type DRUG

Other Intervention Names

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Individually compounded parenteral nutrition

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No