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

Primary Purpose

Laparotomy, Bowel Obstruction, Ischemia, Mesenteric

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
SmofKabiven
Sponsored by
Copenhagen University Hospital at Herlev
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Laparotomy focused on measuring Major emergency laparotomy, Supplementary parenteral nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Early supplementary

    Late supplementary

    Arm Description

    Start of study drug on postoperative day 2

    Start of study drug on postoperative day 5

    Outcomes

    Primary Outcome Measures

    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,

    Secondary Outcome Measures

    Non-infectious complication rate during admission
    Stratified by type and severity (Clavien-Dindo classification)
    Days with need for antibiotics
    Days the participant received antibiotic treatment
    Length of stay
    Time from admission to discharge
    Mortality rate (day 30, 90, and 180)
    Mortality at day 30, 90, and 180
    Emergency readmission rate (day 30, 90, and 180)
    Has the participant been re-admitted within 30, 90, or 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.
    Post-discharge weight status
    Weight at day 30 and 90
    Routes of energy delivery
    Oral intake, enteral intake, parenteral intake or a combination of the three
    Energy intake during admission
    Measured in calories
    Protein intake during admission
    Measured in grams of protein

    Full Information

    First Posted
    September 26, 2023
    Last Updated
    October 13, 2023
    Sponsor
    Copenhagen University Hospital at Herlev
    Collaborators
    Copenhagen University Hospital, Hvidovre, Nordsjaellands Hospital, Slagelse Sygehus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06089551
    Brief Title
    Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery
    Acronym
    EATERS
    Official Title
    Early Versus Postponed Supplementary Parenteral Nutrition After Major Emergency Abdominal Surgery: A Randomized, Controlled Multicenter Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 25, 2023 (Anticipated)
    Primary Completion Date
    October 25, 2025 (Anticipated)
    Study Completion Date
    January 1, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Copenhagen University Hospital at Herlev
    Collaborators
    Copenhagen University Hospital, Hvidovre, Nordsjaellands Hospital, Slagelse Sygehus

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Laparotomy, Bowel Obstruction, Ischemia, Mesenteric
    Keywords
    Major emergency laparotomy, Supplementary parenteral nutrition

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized study with two study groups
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    342 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Early supplementary
    Arm Type
    Experimental
    Arm Description
    Start of study drug on postoperative day 2
    Arm Title
    Late supplementary
    Arm Type
    Active Comparator
    Arm Description
    Start of study drug on postoperative day 5
    Intervention Type
    Drug
    Intervention Name(s)
    SmofKabiven
    Other Intervention Name(s)
    SmofKabiven Perifer
    Intervention Description
    Participants will receive supplementary parenteral nutrition based on their calorie intake. The dosage will be adjusted on a daily basis depending on intake.
    Primary Outcome Measure Information:
    Title
    Infectious complications during admission
    Description
    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,
    Time Frame
    1 week after hospital discharge
    Secondary Outcome Measure Information:
    Title
    Non-infectious complication rate during admission
    Description
    Stratified by type and severity (Clavien-Dindo classification)
    Time Frame
    1 week after hospital discharge
    Title
    Days with need for antibiotics
    Description
    Days the participant received antibiotic treatment
    Time Frame
    1 week after hospital discharge
    Title
    Length of stay
    Description
    Time from admission to discharge
    Time Frame
    Up to 30 days
    Title
    Mortality rate (day 30, 90, and 180)
    Description
    Mortality at day 30, 90, and 180
    Time Frame
    Assessed 180 days after surgery
    Title
    Emergency readmission rate (day 30, 90, and 180)
    Description
    Has the participant been re-admitted within 30, 90, or 180 days after surgery
    Time Frame
    Assessed 180 days after surgery
    Title
    Post-discharge nutritional status
    Description
    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.
    Time Frame
    Assessed at day 30 and 90 after surgery
    Title
    Post-discharge weight status
    Description
    Weight at day 30 and 90
    Time Frame
    Assessed at day 30 and 90 after surgery
    Title
    Routes of energy delivery
    Description
    Oral intake, enteral intake, parenteral intake or a combination of the three
    Time Frame
    Up to two weeks
    Title
    Energy intake during admission
    Description
    Measured in calories
    Time Frame
    Up to two weeks
    Title
    Protein intake during admission
    Description
    Measured in grams of protein
    Time Frame
    Up to two weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jannick B Hansen, M.D.
    Phone
    +4538686862
    Email
    jannick.brander.hansen@regionh.dk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jakob Burcharth, M.D., Ph.D
    Phone
    +4538686568
    Email
    jakob.burcharth@regionh.dk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jannick B Hansen, M.D.
    Organizational Affiliation
    Copenhagen University Hospital at Herlev
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD will not be share as per Danish Law and The Data Data Protection Agency

    Learn more about this trial

    Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery

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