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Intradialytic Parenteral Nutrition in Hemodialysis Patients

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00501956
Acronym
IDPNHD
Enrollment
140
Registered
2007-07-17
Start date
2004-07-31
Completion date
2010-12-31
Last updated
2016-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complication of Hemodialysis, Malnutrition

Keywords

chronic renal replacement therapy, malnutrition anorexia, parenteral nutrition

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).

Interventions

DRUGIntradialytic Parenteral Nutrition (IDPN)

compounded IDPN, 3 x/week, 16 weeks intervention

Sponsors

Institute for Clinical Research
CollaboratorOTHER
Fresenius Kabi
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in prealbumin levels8 weeks

Secondary

MeasureTime frame
Serum albumin, transferrin, nutritional status8 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 14, 2026