Ignite Creation Date:
2024-05-05 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00501956
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2007-07-16
Brief Title:
Intradialytic Parenteral Nutrition in Hemodialysis Patients
Sponsor:
Fresenius Kabi
Organization:
Fresenius Kabi
Study Overview
Official Title:
Randomized Study on the Effect of Intradialytic Parenteral Nutrition in Malnourished Hemodialysis Patients
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IDPNHD
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 IDPNduring 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
In cases where primary treatment of malnutrition is not effective intradialytic parenteral nutrition IDPNduring 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 06 gkgBW and day
The conventional treatment of malnutrition include dietetic counseling psychologic advice and giving additional oral nutrientsIn 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 avoidedDuring 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
The conventional treatment of malnutrition include dietetic counseling psychologic advice and giving additional oral nutrientsIn 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 avoidedDuring 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None