Intradialytic Parenteral Nutrition in Hemodialysis Patients (IDPNHD)
Primary Purpose
Malnutrition, Complication of Hemodialysis
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Intradialytic Parenteral Nutrition (IDPN)
Sponsored by
About this trial
This is an interventional treatment trial for Malnutrition focused on measuring chronic renal replacement therapy, malnutrition anorexia, parenteral nutrition
Eligibility Criteria
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
Sites / Locations
- Interneph e.V. Institute for Applied Nephrology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intradialytic parenteral nutrition
Control Group
Arm Description
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.
Observation over 28 weeks (16 + 12 weeks).
Outcomes
Primary Outcome Measures
Change in prealbumin levels
Secondary Outcome Measures
Serum albumin, transferrin, nutritional status
Full Information
NCT ID
NCT00501956
First Posted
July 16, 2007
Last Updated
March 1, 2016
Sponsor
Fresenius Kabi
Collaborators
Institute for Clinical Research
1. Study Identification
Unique Protocol Identification Number
NCT00501956
Brief Title
Intradialytic Parenteral Nutrition in Hemodialysis Patients
Acronym
IDPNHD
Official Title
Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Kabi
Collaborators
Institute for Clinical Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Complication of Hemodialysis
Keywords
chronic renal replacement therapy, malnutrition anorexia, parenteral nutrition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intradialytic parenteral nutrition
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Observation over 28 weeks (16 + 12 weeks).
Intervention Type
Drug
Intervention Name(s)
Intradialytic Parenteral Nutrition (IDPN)
Other Intervention Name(s)
Individually compounded parenteral nutrition
Intervention Description
compounded IDPN, 3 x/week, 16 weeks intervention
Primary Outcome Measure Information:
Title
Change in prealbumin levels
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Serum albumin, transferrin, nutritional status
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helmut Mann, Prof. Dr.
Organizational Affiliation
Interneph e.V, Aachen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Interneph e.V. Institute for Applied Nephrology
City
Aachen
ZIP/Postal Code
52074
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12189236
Citation
Mitch WE. Malnutrition: a frequent misdiagnosis for hemodialysis patients. J Clin Invest. 2002 Aug;110(4):437-9. doi: 10.1172/JCI16494. No abstract available.
Results Reference
background
PubMed Identifier
26708726
Citation
Marsen TA, Beer J, Mann H; German IDPN-Trial group. Intradialytic parenteral nutrition in maintenance hemodialysis patients suffering from protein-energy wasting. Results of a multicenter, open, prospective, randomized trial. Clin Nutr. 2017 Feb;36(1):107-117. doi: 10.1016/j.clnu.2015.11.016. Epub 2015 Dec 12.
Results Reference
derived
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Intradialytic Parenteral Nutrition in Hemodialysis Patients
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