LaparotomyPhase 4EATERSNCT06089551
Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery
A Phase 4 study testing SmofKabiven in people with Laparotomy and Bowel Obstruction, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparotomy, Bowel Obstruction, Ischemia, Mesenteric
- What is being tested?
- SmofKabiven
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Oct 2023to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Capable of providing informed consent at the time of inclusion
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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 50% 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.
- Conditions
- Laparotomy, Bowel Obstruction, Ischemia, Mesenteric
- Being tested
- SmofKabiven
- Keywords
- Major emergency laparotomy, Supplementary parenteral nutrition
- Medical subject headings
- Intestinal Obstruction, Mesenteric Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SmofKabivenDrug
Also called SmofKabiven Perifer
Participants will receive supplementary parenteral nutrition based on their calorie intake. The dosage will be adjusted on a daily basis depending on intake.
| Study group | Role | What they receive |
|---|---|---|
| Early supplementary | Experimental | Start of study drug on postoperative day 2 Receives: Drug: SmofKabiven |
| Late supplementary | Active comparator | Start of study drug on postoperative day 5 Receives: Drug: SmofKabiven |
What is being measured
The primary outcome is the main question the study is designed to answer.
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,
Measured: 1 week after hospital discharge
Secondary outcomes (10)
Non-infectious complication rate during admission
Stratified by type and severity (Clavien-Dindo classification)
Measured: 1 week after hospital discharge
Days with need for antibiotics
Days the participant received antibiotic treatment
Measured: 1 week after hospital discharge
Length of stay
Time from admission to discharge
Measured: Up to 30 days
Mortality rate (day 30 and 90)
Mortality at day 30 and 90
Measured: Assessed 90 days after surgery
Emergency readmission rate (day 30 and 90)
Has the participant been re-admitted within 30 or 90 days after surgery
Measured: Assessed 90 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.
Measured: Assessed at day 30 and 90 after surgery
Post-discharge weight status
Weight at day 30 and 90
Measured: Assessed at day 30 and 90 after surgery
Routes of energy delivery
Oral intake, enteral intake, parenteral intake or a combination of the three
Measured: Up to two weeks
Energy intake during admission
Measured in calories
Measured: Up to two weeks
Protein intake during admission
Measured in grams of protein
Measured: Up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start18 Oct 2023
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized study with two study groups
- Masking
- None (open label)
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital at Herlev
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, Nordsjaellands Hospital, Slagelse Sygehus, Aarhus University Hospital, Gødstrup Hospital, Aalborg University Hospital, Bispebjerg Hospital, Zealand University Hospital, Holbaek Sygehus
- Responsible party
- Principal investigator, Jannick Brander Hansen, Copenhagen University Hospital at Herlev
- Investigators
- Jannick B Hansen, M.D., Principal investigator, Copenhagen University Hospital at Herlev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089551
- Sponsor's protocol ID
- The EATERS Trial
- Acronym
- EATERS
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be share as per Danish Law and The Data Data Protection Agency
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Versus Postponed Supplementary Parenteral Nutrition After Major Emergency Abdominal Surgery: A Randomized, Controlled Multicenter Trial
- ClinicalTrials.gov ID
- NCT06089551
- Acronym / sponsor ID
- EATERS / The EATERS Trial
- Conditions
- Laparotomy, Bowel Obstruction, Ischemia, Mesenteric
- Keywords
- Major emergency laparotomy, Supplementary parenteral nutrition
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital at HerlevUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Hvidovre, Nordsjaellands Hospital, Slagelse Sygehus, Aarhus University Hospital, Gødstrup Hospital, Aalborg University Hospital, Bispebjerg Hospital, Zealand University Hospital, Holbaek Sygehus
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 50% 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized study with two study groups
| Arm | Type | Receives |
|---|---|---|
| Early supplementary | Experimental | Drug: SmofKabivenStart of study drug on postoperative day 2 |
| Late supplementary | Active comparator | Drug: SmofKabivenStart of study drug on postoperative day 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SmofKabivenAlso: SmofKabiven PeriferParticipants will receive supplementary parenteral nutrition based on their calorie intake. The dosage will be adjusted on a daily basis depending on intake. | Drug | Early supplementary, Late supplementary |
Primary outcome
Infectious complications during admission
Time frame: 1 week after hospital discharge
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,
10 secondary outcomes
Non-infectious complication rate during admission
Time frame: 1 week after hospital discharge
Days with need for antibiotics
Time frame: 1 week after hospital discharge
Length of stay
Time frame: Up to 30 days
Mortality rate (day 30 and 90)
Time frame: Assessed 90 days after surgery
Emergency readmission rate (day 30 and 90)
Time frame: Assessed 90 days after surgery
Post-discharge nutritional status
Time frame: Assessed at day 30 and 90 after surgery
Post-discharge weight status
Time frame: Assessed at day 30 and 90 after surgery
Routes of energy delivery
Time frame: Up to two weeks
Energy intake during admission
Time frame: Up to two weeks
Protein intake during admission
Time frame: Up to two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. IPD will not be share as per Danish Law and The Data Data Protection Agency
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jannick B Hansen, M.D. principal investigator
Copenhagen University Hospital at Herlev
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SmofKabiven in people with Laparotomy and Bowel Obstruction, run by Copenhagen University Hospital at Herlev at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infectious complications during admission (time frame: 1 week after hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.