Ignite Creation Date:
2024-05-05 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00530738
Status:
COMPLETED
Last Update Posted:
2014-07-18
First Post:
2007-09-14
Brief Title:
Safety and Efficacy of Longterm HPN With Two Lipid Emulsions
Sponsor:
B Braun Melsungen AG
Organization:
B Braun Melsungen AG
Study Overview
Official Title:
Efficacy Safety and Quality of Life of a Long-term Home Parenteral Nutrition Regimen With Either LIPIDEM or LIPOFUNDIN MCT a Mono-center Randomized Double Blind Study
Status:
COMPLETED
Status Verified Date:
2014-07
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:
None
Brief Summary:
It is the purpose of this trial to provide evidence for safety and efficacy of long term home parenteral nutrition with either Lipofundin MCT or Lipoplus in patients with proven insufficient enteral resorption
Detailed Description:
Long term parenteral nutrition is indicated in the home care setting of patients who are unable to completely cover their daily caloric requirements by oralenteral nutrition due to eg pre existing malnutrition or compromised intestinal absorption
An appropriate nutritional supplementation ensuring the provision of patients basic requirement of amino acids glucose lipids micronutrients and electrolytes is therefore required to stop weight loss increase quality of life and to reduce unfavorable consequences of malnutrition in those patients
Major causes for malnutrition and compromised intestinal absorption are malignant processes Tumor cachexia weight loss due to insufficient nutrition of 60 -80 of the calculated substrate need for 14 days antineoplastic therapy and surgical intervention are consequences of the malignant disease and lead to catabolic processes
An appropriate nutritional supplementation ensuring the provision of patients basic requirement of amino acids glucose lipids micronutrients and electrolytes is therefore required to stop weight loss increase quality of life and to reduce unfavorable consequences of malnutrition in those patients
Major causes for malnutrition and compromised intestinal absorption are malignant processes Tumor cachexia weight loss due to insufficient nutrition of 60 -80 of the calculated substrate need for 14 days antineoplastic therapy and surgical intervention are consequences of the malignant disease and lead to catabolic processes
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EudraCT-Nr 2005-001938-32 | None | None | None |