Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06458387
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-05
Brief Title:
Comparison of Clinical Outcomes According to High-protein Provision in Critically Ill Patients After Abdominal Surgery
Sponsor:
Seoul St Marys Hospital
Organization:
Seoul St Marys Hospital
Study Overview
Official Title:
Comparison of Clinical Outcomes According to High-protein Provision Through Parenteral Nutrition in Critically Ill Patients Immediately After Abdominal Surgery a Prospective Single-blinded Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Protein malnutrition in critically ill patients is a global concern due to its association with prolonged hospital stays and higher morbidity rates Patients who undergo abdominal surgery are particularly vulnerable due to alterations in gastrointestinal function and prolonged fasting Despite the significance of proper nutrition the optimal target of protein supplementation remains controversial
The investigators aimed to evaluate the effects of high protein provision targeting a protein intake of at least 15 gkgday for the first 3 days after abdominal surgery on 6-month mortality
The investigators aimed to evaluate the effects of high protein provision targeting a protein intake of at least 15 gkgday for the first 3 days after abdominal surgery on 6-month mortality
Detailed Description:
During the acute phase of critical illness patients experience metabolic and physiological changes that affects their nutrition status One prominent feature is the activation of stress hormones and inflammatory mediators which contribute to a negative nitrogen balance increased gluconeogenesis and accelerated muscle proteolysis Among these patients those who undergo abdominal surgery are particularly vulnerable to malnutrition as they experience alterations in the structural barrier of the gastrointestinal tract impaired nutrient absorption and prolonged fasting due to concerns such as the integrity of an anastomosis Thus appropriate protein provision should be prioritized for critically ill patients following abdominal surgery and it should include adequate nutritional support to preserve lean body mass and organ function Despite the importance of nutritional supply the recommendations for protein vary according to different guidelines and this is the same for surgical patients Recent randomized controlled trials reported conflicting results with current guidelines with some suggesting that higher protein dose administrations did not significantly impact clinical outcomes and may even worsen the outcomes for certain patient groups Thus the optimal protein provision target during the acute phase of critical illness particularly for surgical patients remains controversial
The investigators aimed to assess the effects of strict high protein provision between the high protein group protein target supplemented with 15 gkgday and the control group protein target supplemented with less than 15 gkgday using intravenous nutrient solution for the first 3 days after abdominal surgery Additionally the investigators investigated the appropriate target for protein provision in critically ill patients who undergo abdominal surgery
The investigators aimed to assess the effects of strict high protein provision between the high protein group protein target supplemented with 15 gkgday and the control group protein target supplemented with less than 15 gkgday using intravenous nutrient solution for the first 3 days after abdominal surgery Additionally the investigators investigated the appropriate target for protein provision in critically ill patients who undergo abdominal surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None