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Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients (OPPortuNity)

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ClinicalTrials.gov Identifier: NCT03926949
Recruitment Status : Not yet recruiting
First Posted : April 25, 2019
Last Update Posted : April 26, 2019
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
Leah Gramlich, University of Alberta

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Malnutrition Surgery Other: Parenteral Nutrition Other: Standard Nutrition Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients: A Feasibility Study
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arm Intervention/treatment
Active Comparator: Intervention group
Participants will receive parenteral nutrition (Olimel 7.6% E 1000 ml), infused over 4-5 hours at outpatient infusion clinic for 5-10 days within 14 days prior to surgery.
Other: Parenteral Nutrition
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 Name: Olimel 7.6% E 1000 ml

Control group
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
Other: Standard Nutrition Care
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 Outcome Measures :
  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 Outcome Measures :
  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

    1. completely disagree with intervention
    2. disagree with intervention
    3. neither agree nor disagree with intervention
    4. agree with intervention
    5. completely agree with intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18 years of age or older
  2. 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:

  1. Patients undergoing minor or laparoscopic surgery
  2. Pregnancy
  3. Patients with severe systemic diseases defined by American Society of Anesthesiologists (ASA) classification III to V
  4. Patients with diabetes mellitus
  5. Patients with planned palliative treatment
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Responsible Party: Leah Gramlich, Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT03926949    
Other Study ID Numbers: 19G2208
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malnutrition
Nutrition Disorders