Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery

NCT06089551 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 342

Last updated 2025-02-12

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Copenhagen University Hospital, Hvidovre

    collaborator OTHER
  • Nordsjaellands Hospital

    collaborator OTHER
  • Slagelse Sygehus

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • Gødstrup Hospital

    collaborator OTHER
  • Aalborg University Hospital

    collaborator OTHER
  • Bispebjerg Hospital

    collaborator OTHER
  • Zealand University Hospital

    collaborator OTHER
  • Holbaek Sygehus

    collaborator OTHER
  • Copenhagen University Hospital at Herlev

    lead OTHER

Principal Investigators

  • Jannick B Hansen, M.D. · Copenhagen University Hospital at Herlev

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-18
Primary Completion
2025-10-25
Completion
2026-01-01

Countries

  • Denmark

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06089551 on ClinicalTrials.gov