Ignite Creation Date:
2024-05-06 @ 7:39 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06089551
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2023-09-26
Brief Title:
Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery
Sponsor:
Copenhagen University Hospital at Herlev
Organization:
Copenhagen University Hospital at Herlev
Study Overview
Official Title:
Early Versus Postponed Supplementary Parenteral Nutrition After Major Emergency Abdominal Surgery A Randomized Controlled Multicenter Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
EATERS
Brief Summary:
The aim of this study is to investigate the effect of early supplementary parenteral nutrition following emergency laparotomy
Currently parenteral nutrition is used in postoperative patients if or when oral or enteral nutrition is not feasible However little data exists on the optimal timing of parenteral nutrition
Oral and enteral nutrition is encouraged Participants will randomized on the second postoperative day if their calorie intake oral enteral is below 30 of the calculated requirement Patients will be randomized to early postoperative day 2 or postponed postoperative day 5 start of parenteral nutrition
The combined oral enteral parenteral calorie target is 70-80 of the calculated requirement Participants in the postponed group will be re-assessed on postoperative day 5 and if their calorie intake is less than 50 parenteral nutrition will be administered
The intervention will continue until oral enteral intake is at least 70 of the calculated requirement or the participant is at hisher habitual intake
Currently parenteral nutrition is used in postoperative patients if or when oral or enteral nutrition is not feasible However little data exists on the optimal timing of parenteral nutrition
Oral and enteral nutrition is encouraged Participants will randomized on the second postoperative day if their calorie intake oral enteral is below 30 of the calculated requirement Patients will be randomized to early postoperative day 2 or postponed postoperative day 5 start of parenteral nutrition
The combined oral enteral parenteral calorie target is 70-80 of the calculated requirement Participants in the postponed group will be re-assessed on postoperative day 5 and if their calorie intake is less than 50 parenteral nutrition will be administered
The intervention will continue until oral enteral intake is at least 70 of the calculated requirement or the participant is at hisher habitual intake
Detailed Description:
Screening for potential participants will be done using the patient records which includes primary procedure age NRS-2002 score and total calorie intake within the last 24 hours Only information needed to determine eligibility in this study will be noted ahead of informed consent
Enteral or oral feeding is encouraged as soon as possible postoperatively for all patients unless they have contraindications for oral intake If they have contraindications for oral intake they are excluded from participation Appendix 2 The caloric target is set to 25 kcalkgday For patients with a body mass index 30 kgm2 the target will be calculated using their weight at body mass index 25 kgm2 Oral protein supplements are encouraged in all patients Nutritional calculations and monitoring can be performed locally according to the participating centers standard clinical practice by dieticians nurses or clinical doctors
Patients that cannot achieve more than 30 of their calorie intake on POD2 and do not fulfill any of the exclusion criteria are randomized to early parenteral E-SPN POD2 or postponed parenteral L-SPN POD5 The L-SPN group will continue standard oral or enteral intake until POD5 where the parenteral nutritional intervention begins if they have not yet met at least 50 of recommended daily oral or enteral recommended intake on their own
After randomization the patients should receive 70-80 of recommended daily energy and protein intake Calculations will be made daily by a combination of oral enteral and parenteral administered nutrition In case of incomplete calorie intake registration the most recent dose will be administered
If patients are in need of supplemental parenteral nutrition for more than seven days a centrally administered route should be used The standard trial supplemental nutritional product will be SmofKabiven Perifer unless there is a clinical rationale for using SmofKabiven These include treatment duration 7 days risk of overhydration calorie requirement exceeding the limit for SmofKabiven Perifer 1300 kcal Both products will be used in accordance with the summary of product characteristics Use of either product is not expected to impact data analysis as supplementary calorie amount is unrelated to the product
Both investigational medicinal products IMP will be supplied by the local hospital pharmacy All IMPs are stored in a dedicated medicine storage room located on each hospital ward Handling IMPs will be in accordance with the regional guideline on the use of parenteral nutrition Parenteral ernæring for voksne - procedure og forholdsregler section 3 - vipregionhdk The dosage is evaluated daily and is documented in the patient chart in Sundhedsplatformen Epic Systems Corporation Verona Wisconsin as is the time of infusion start
Batch number and expiration date will be registered on a worksheet along with the end-infused dose Worksheets will be stored in the Trial Master File
Destruction of the IMP will be in accordance with local standards
Patients will be monitored regarding complications nutritional intake calories protein lipids and safety parameters risk of overfeeding and refeeding as standard
Enteral or oral feeding is encouraged as soon as possible postoperatively for all patients unless they have contraindications for oral intake If they have contraindications for oral intake they are excluded from participation Appendix 2 The caloric target is set to 25 kcalkgday For patients with a body mass index 30 kgm2 the target will be calculated using their weight at body mass index 25 kgm2 Oral protein supplements are encouraged in all patients Nutritional calculations and monitoring can be performed locally according to the participating centers standard clinical practice by dieticians nurses or clinical doctors
Patients that cannot achieve more than 30 of their calorie intake on POD2 and do not fulfill any of the exclusion criteria are randomized to early parenteral E-SPN POD2 or postponed parenteral L-SPN POD5 The L-SPN group will continue standard oral or enteral intake until POD5 where the parenteral nutritional intervention begins if they have not yet met at least 50 of recommended daily oral or enteral recommended intake on their own
After randomization the patients should receive 70-80 of recommended daily energy and protein intake Calculations will be made daily by a combination of oral enteral and parenteral administered nutrition In case of incomplete calorie intake registration the most recent dose will be administered
If patients are in need of supplemental parenteral nutrition for more than seven days a centrally administered route should be used The standard trial supplemental nutritional product will be SmofKabiven Perifer unless there is a clinical rationale for using SmofKabiven These include treatment duration 7 days risk of overhydration calorie requirement exceeding the limit for SmofKabiven Perifer 1300 kcal Both products will be used in accordance with the summary of product characteristics Use of either product is not expected to impact data analysis as supplementary calorie amount is unrelated to the product
Both investigational medicinal products IMP will be supplied by the local hospital pharmacy All IMPs are stored in a dedicated medicine storage room located on each hospital ward Handling IMPs will be in accordance with the regional guideline on the use of parenteral nutrition Parenteral ernæring for voksne - procedure og forholdsregler section 3 - vipregionhdk The dosage is evaluated daily and is documented in the patient chart in Sundhedsplatformen Epic Systems Corporation Verona Wisconsin as is the time of infusion start
Batch number and expiration date will be registered on a worksheet along with the end-infused dose Worksheets will be stored in the Trial Master File
Destruction of the IMP will be in accordance with local standards
Patients will be monitored regarding complications nutritional intake calories protein lipids and safety parameters risk of overfeeding and refeeding as standard
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?:
False
Is an FDA AA801 Violation?:
None