Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery (EATERS)

Early Versus Postponed Supplementary Parenteral Nutrition After Major Emergency Abdominal Surgery: A Randomized, Controlled Multicenter Trial

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 his/her habitual intake.

Study Overview

• Status: Recruiting
• Conditions: Laparotomy; Bowel Obstruction; Ischemia, Mesenteric
• Intervention / Treatment: Drug: SmofKabiven

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 kcal/kg/day. For patients with a body mass index > 30 kg/m2 the target will be calculated using their weight at body mass index 25 kg/m2. 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 - vip.regionh.dk). 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 Type: Interventional
• Enrollment (Estimated): 342
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jannick B Hansen, M.D.; Phone Number: +4538686862; Email: jannick.brander.hansen@regionh.dk
• Study Contact Backup: Name: Jakob Burcharth, M.D., Ph.D; Phone Number: +4538686568; Email: jakob.burcharth@regionh.dk

Study Locations

• Denmark
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev Hospital
    • Contact: Jannick B Hansen, MD; Phone Number: 38686862; Email: jannick.brander.hansen@regionh.dk
    • Contact: Jakob Burcharth, MD; Phone Number: 38686568; Email: jakob.burcharth@regionh.dk
    • Principal Investigator: Jannick B Hansen, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age > 18
• Emergency primary midline laparotomy
• Preoperative NRS-2002 (nutritional risk screening) score < 7
• No contraindications for oral or enteral nutrition after surgery
• Unable to tolerate or take in at least 30% of calculated calorie requirement on postoperative day 2
• Capable of providing informed consent at the time of inclusion

Exclusion Criteria:

• Laparotomy without closure of the abdominal aponeurosis
• Non-midline incision
• Laparoscopic procedure
• Limiting mental or psychiatric disorders rendering participation unethical or unrealistic
• Patients with a very limited expected remaining time of living (< 3 months)
• Preoperative NRS-2002 = 7
• Pregnant or breastfeeding women
• Refusal to participate
• Emergency reoperations

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early supplementary; Start of study drug on postoperative day 2	Drug: SmofKabiven; Participants will receive supplementary parenteral nutrition based on their calorie intake. The dosage will be adjusted on a daily basis depending on intake.; Other Names: SmofKabiven Perifer
Active Comparator: Late supplementary; Start of study drug on postoperative day 5	Drug: SmofKabiven; Participants will receive supplementary parenteral nutrition based on their calorie intake. The dosage will be adjusted on a daily basis depending on intake.; Other Names: SmofKabiven Perifer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infectious complications during admission	Rate of infectious complications during admission. The following infections will be registered: Urinary tract infections, pneumonia, bloodstream infections, surgical site infections, abdominal infections, and skin and soft tissue infections,	1 week after hospital discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-infectious complication rate during admission	Stratified by type and severity (Clavien-Dindo classification)	1 week after hospital discharge
Days with need for antibiotics	Days the participant received antibiotic treatment	1 week after hospital discharge
Length of stay	Time from admission to discharge	Up to 30 days
Mortality rate (day 30, 90, and 180)	Mortality at day 30, 90, and 180	Assessed 180 days after surgery
Emergency readmission rate (day 30, 90, and 180)	Has the participant been re-admitted within 30, 90, or 180 days after surgery	Assessed 180 days after surgery
Post-discharge nutritional status	SNAQ (Simplified Nutritional Appetite Questionnaire) screening tool and weight at day 30 and 90. A score between 5 and 20 is possible with a higher score being better.	Assessed at day 30 and 90 after surgery
Post-discharge weight status	Weight at day 30 and 90	Assessed at day 30 and 90 after surgery
Routes of energy delivery	Oral intake, enteral intake, parenteral intake or a combination of the three	Up to two weeks
Energy intake during admission	Measured in calories	Up to two weeks
Protein intake during admission	Measured in grams of protein	Up to two weeks

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital at Herlev
• Collaborators: Copenhagen University Hospital, Hvidovre; Nordsjaellands Hospital; Slagelse Sygehus
• Investigators: Principal Investigator: Jannick B Hansen, M.D., Copenhagen University Hospital at Herlev

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): October 25, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: September 26, 2023
• First Submitted That Met QC Criteria: October 13, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Major emergency laparotomy; Supplementary parenteral nutrition
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Peritoneal Diseases; Disease Attributes; Gastrointestinal Diseases; Intestinal Diseases; Emergencies; Ischemia; Intestinal Obstruction; Mesenteric Ischemia
• Other Study ID Numbers: The EATERS Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be share as per Danish Law and The Data Data Protection Agency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No