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NCT Number: NCT03926949

Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients

Malnutrition is common in surgical patients. Many studies have shown a clear association between malnutrition and poor surgical outcomes. Parenteral nutrition (PN) is a nutrition intervention that is given by vein and can be safely provided to malnourished patients. It contains carbohydrates, fats, and protein just like you would normally in your diet. Pre-operative PN is able to improve outcomes in surgical patients. However, pre-operative PN has traditionally required hospital admission which results in increased length of stay, hospital cost, and hospital-acquired infection. Moreover, in hospital pre-operative PN may not be feasible or prioritized when access to inpatient surgery beds is limited. Outpatient PN provides the opportunity to solve this problem. The feasibility and impact of outpatient PN in malnourished patients undergoing major surgery have not previously been studied. This study aims to evaluate the feasibility of outpatient pre-operative PN and its effect on patient's outcomes.

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Key information

Conditions

Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Alexandra Hospital, Edmonton, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients 18 years of age or older
  • Patients screened at risk of malnutrition by Canadian Nutrition Screening Tool (CNST) and identified as malnourished by subjective global assessment (SGA) B or C

Exclusion criteria

  • Patients undergoing minor or laparoscopic surgery
  • Pregnancy
  • Patients with severe systemic diseases defined by American Society of Anesthesiologists (ASA) classification III to V
  • Patients with diabetes mellitus
  • Patients with planned palliative treatment

Treatment and study plan

Parenteral nutrition

Other

Olimel 7.6% E 1000 ml will be infused over 4-5 hours at outpatient infusion clinic for 5-10 days within 14 days prior to surgery.

Other names: Olimel 7.6% E 1000 ml

Standard Nutrition Care

Other

Participants will receive nutrition therapy by registered dietitians within 14 days prior to surgery. Patients with SGA B and SGA C will receive advanced nutrition care and specialized nutrition care, respectively.

Primary outcomes

  1. Rate of parenteral nutrition completion

    Time frame: through study completion, an average of 1 year

    Rate of parenteral nutrition completion calculated by the number of patients who can complete parenteral nutrition before surgery for 5-10 days divided by total number of patients in parenteral nutrition group

  2. Postoperative complications evaluated by Clavien-Dindo Classification

    Time frame: through study completion, an average of 1 year

    Clavien-Dindo Classification classifies postoperative complications into 5 grades (grade I to grade V) from mild to severe complications Grade I: no need specific intervention Grade II: need phamacological treatment Grade III: need surgical/endoscopic/radiological intervention Grade IV: life-threatening complications requiring ICU managment Grade V: death of a patient

Secondary outcomes

  1. Length of hospital stay

    Time frame: through study completion, an average of 1 year

    Duration between hospital admission to discharge

  2. Quality of life: Short Form (SF)-12 questionnaire

    Time frame: 5-10 days during parenteral nutrition infusion

    Quality of life evaluated by Short Form (SF)-12 questionnaire A mental component score (MCS-12) and a physical component score (PCS-12) are calculated by summation of mental and physical questions, respectively. The score range from 0-100, which the higher score means the better quality of life.

  3. Body weight

    Time frame: 5-10 days during parenteral nutrition infusion

    Body weight measurement in kilograms

  4. Nutrition status

    Time frame: 5-10 days during parenteral nutrition infusion

    Nutrition status evaluated by patient-generated subjective global assessment

    Patient-generated subjective global assessment divides a patient into 3 groups:

    A = well-nourished B = moderately malnourished or suspected malnutrition C = severely malnourished The total score is also calculated by summation of scores from weight, food intake, gastrointestinal symptoms, activity, metabolic demand, and physical examination. It ranges from 0-55, which the lower score means the better nutrition status.

  5. Muscle power

    Time frame: 5-10 days during parenteral nutrition infusion

    Muscle power evaluated by handgrip strength test

  6. Cost-saving

    Time frame: through study completion, an average of 1 year

    Difference in total length of stay (primary length of stay plus length of stay during readmission) between 2 groups multiplies by estimated unit cost of inpatient hospital stay per day from Alberta Health Service

  7. Hospital readmission

    Time frame: 30 days after discharge

    Readmission rate within 30 days after discharge

  8. Total energy from parenteral nutrition

    Time frame: 5-10 days during parenteral nutrition infusion

    Total energy from parenteral nutrition measured by total energy in kilocalories per day multiply by total days of parenteral nutrition

  9. Total protein from parenteral nutrition

    Time frame: 5-10 days during parenteral nutrition infusion

    Total protein from parenteral nutrition measured by total protein in grams per day multiply by total days of parenteral nutrition

  10. Acceptability, appropriateness, and feasibility of intervention measured by Acceptability, Appropriateness, and Feasibility Questionnaire

    Time frame: through study completion, an average of 1 year

    Acceptability, Appropriateness, and Feasibility Questionnaire included score 1 to 5

    • completely disagree with intervention
    • disagree with intervention
    • neither agree nor disagree with intervention
    • agree with intervention
    • completely agree with intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Leah Gramlich, MD

CONTACT

[email protected]

17809204362

Narisorn Lakananurak, MD

CONTACT

[email protected]

17808865718

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Baxter Healthcare Corporation

Registry information

Official study title

Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients: A Feasibility Study

Acronym: OPPortuNity

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2019
Registry last updated
Aug 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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