Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00339053
Status:
UNKNOWN
Last Update Posted:
2006-10-23
First Post:
2006-06-19
Brief Title:
Immunonutrition and Thoracoabdominal Aorta Aneurysm Repair
Sponsor:
St Antonius Hospital
Organization:
St Antonius Hospital
Study Overview
Official Title:
The Effect of Immunonutrition on Outcome and Postoperative Recovery in Patients Undergoing Elective Surgical Repair of a Thoraco Abdominal Aneurysm Aorta
Status:
UNKNOWN
Status Verified Date:
2006-10
Last Known Status:
RECRUITING
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:
The purpose of this study is to determine whether immunonutrition and pre operative nutrition can reduce lenght of respirator support lenght of stay in the ICU and incidence of post operative infections
Detailed Description:
Elective surgical repair of a Thoraco Abdominal Aneurysm Aorta TAAA is associated with high mortality and morbidity Important complications are renal failure paraplegia and respiratory failure
A retrospective study we performed also revealed high post operative infection rates and high incidence of respiratory failure
Improving immune status may reduce the occurrence of infections due to immune chances Immunonutrition may enhance the patients immune system Many clinical trials of immunonutrition in critically ill and surgical patients have been performed In meta-analyses it has been shown that immunonutrition results in lower infections rates and shorter length of stay in hospital after major surgery Immunonutrition has not been studied yet in TAAA surgery Controversy exists in septic patients
We designed a prospective randomized placebo controlled trial to study the effect of immunonutrition on time on ventilatorsupport lenght of stay in the intensive care unit and incidence of postoperative infections after TAAA surgery Patients start with oral supplements besides their normal diet 5 days before surgery After the operation the nutrition is continued by protocol and administered by nasogastric tube until normal entral feeding is possible The control group wil receive iso caloric and iso nitrogen nutrition
A retrospective study we performed also revealed high post operative infection rates and high incidence of respiratory failure
Improving immune status may reduce the occurrence of infections due to immune chances Immunonutrition may enhance the patients immune system Many clinical trials of immunonutrition in critically ill and surgical patients have been performed In meta-analyses it has been shown that immunonutrition results in lower infections rates and shorter length of stay in hospital after major surgery Immunonutrition has not been studied yet in TAAA surgery Controversy exists in septic patients
We designed a prospective randomized placebo controlled trial to study the effect of immunonutrition on time on ventilatorsupport lenght of stay in the intensive care unit and incidence of postoperative infections after TAAA surgery Patients start with oral supplements besides their normal diet 5 days before surgery After the operation the nutrition is continued by protocol and administered by nasogastric tube until normal entral feeding is possible The control group wil receive iso caloric and iso nitrogen nutrition
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