Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery

NCT06089551 | Recruiting Phase 4

• 1 other identifier: The EATERS Trial
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

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 50% 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.

Conditions

Laparotomy; Bowel Obstruction; Ischemia, Mesenteric

Keywords

Major emergency laparotomy; Supplementary parenteral nutrition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Non-infectious complication rate during admission

  1 week after hospital discharge

• Days with need for antibiotics

  1 week after hospital discharge

• Length of stay

  Up to 30 days

• Mortality rate (day 30 and 90)

  Assessed 90 days after surgery

• Emergency readmission rate (day 30 and 90)

  Assessed 90 days after surgery

Study Arms (2)

Early supplementary

EXPERIMENTAL

Start of study drug on postoperative day 2

Drug: SmofKabiven

Late supplementary

ACTIVE COMPARATOR

Start of study drug on postoperative day 5

Drug: SmofKabiven

Interventions

SmofKabiven DRUG

Participants will receive supplementary parenteral nutrition based on their calorie intake. The dosage will be adjusted on a daily basis depending on intake.

Also known as: SmofKabiven Perifer

Early supplementary; Late supplementary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Emergency primary midline laparotomy or laparoscopy
• NRS-2002 (nutritional risk screening) score \< 7
• No contraindications for oral or enteral nutrition after surgery
• Unable to tolerate or take in at least 50% of calculated calorie requirement on postoperative day 2

You may not qualify if:

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

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: lead
• Copenhagen University Hospital, Hvidovre: collaborator
• Nordsjaellands Hospital: collaborator
• Slagelse Sygehus: collaborator
• Aarhus University Hospital: collaborator
• Gødstrup Hospital: collaborator
• Aalborg University Hospital: collaborator
• Bispebjerg Hospital: collaborator
• Zealand University Hospital: collaborator
• Holbaek Sygehus: collaborator

Study Sites (1)

Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Intestinal Obstruction; Mesenteric Ischemia

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Peritoneal Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jannick B Hansen, M.D.

  Copenhagen University Hospital at Herlev

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jannick B Hansen, M.D.

CONTACT

+4538686862; jannick.brander.hansen@regionh.dk

Jakob Burcharth, M.D., Ph.D

CONTACT

+4538686568; jakob.burcharth@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized study with two study groups

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 18, 2023
• Study Start: October 18, 2023
• Primary Completion: October 25, 2025
• Study Completion: January 1, 2026
• Last Updated: February 12, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)