This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients (OPPortuNity)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : July 31, 2024
Estimated Study Completion Date : July 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malnutrition

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926949


Contacts
Layout table for location contacts
Contact: Narisorn Lakananurak, MD 17808865718 lakananu@ualberta.ca
Contact: Leah Gramlich, MD 17809204362 lg3@ualberta.ca

Locations
Layout table for location information
Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Contact: Narisorn Lakananurak, MD    7808865718    lakananu@ualberta.ca   
Contact: Leah Gramlich, MD    7809204362    lg3@ualberta.ca   
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Narisorn Lakananurak, MD    17808865718    lakananu@ualberta.ca   
Contact: Leah Gramlich, MD    17809204362    lg3@ualberta.ca   
Sponsors and Collaborators
University of Alberta
Baxter Healthcare Corporation
Investigators
Layout table for investigator information
Principal Investigator: Leah Gramlich, MD University of Alberta
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03926949    
Other Study ID Numbers: 19G2208
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: July 20, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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