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Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients (OPPortuNity)

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ClinicalTrials.gov Identifier: NCT03926949
Recruitment Status : Recruiting
First Posted : April 25, 2019
Last Update Posted : July 20, 2023
Sponsor:
Collaborator:
Baxter Healthcare Corporation
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 25, 2019
Last Update Posted Date July 20, 2023
Actual Study Start Date  ICMJE October 30, 2019
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2019)
  • Length of hospital stay [ Time Frame: through study completion, an average of 1 year ]
    Duration between hospital admission to discharge
  • 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.
  • Body weight [ Time Frame: 5-10 days during parenteral nutrition infusion ]
    Body weight measurement in kilograms
  • 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.
  • Muscle power [ Time Frame: 5-10 days during parenteral nutrition infusion ]
    Muscle power evaluated by handgrip strength test
  • 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
  • Hospital readmission [ Time Frame: 30 days after discharge ]
    Readmission rate within 30 days after discharge
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2019)
  • Length of hospital stay [ Time Frame: through study completion, an average of 1 year ]
    Duration between hospital admission to discharge
  • 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
  • Body weight [ Time Frame: 5-10 days during parenteral nutrition infusion ]
    Body weight measurement in kilograms
  • Nutrition status [ Time Frame: 5-10 days during parenteral nutrition infusion ]
    Nutrition status evaluated by patient-generated subjective global assessment
  • Muscle power [ Time Frame: 5-10 days during parenteral nutrition infusion ]
    Muscle power evaluated by handgrip strength test
  • 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
  • Hospital readmission [ Time Frame: 30 days after discharge ]
    Readmission rate within 30 days after discharge
  • 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
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients
Official Title  ICMJE Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients: A Feasibility Study
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Malnutrition
  • Surgery
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Parenteral Nutrition
  • 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
    Intervention: Other: Standard Nutrition Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2019)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2024
Estimated Primary Completion Date July 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Narisorn Lakananurak, MD 17808865718 lakananu@ualberta.ca
Contact: Leah Gramlich, MD 17809204362 lg3@ualberta.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03926949
Other Study ID Numbers  ICMJE 19G2208
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party University of Alberta
Original Responsible Party Leah Gramlich, University of Alberta, Professor
Current Study Sponsor  ICMJE University of Alberta
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Baxter Healthcare Corporation
Investigators  ICMJE
Principal Investigator: Leah Gramlich, MD University of Alberta
PRS Account University of Alberta
Verification Date July 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP