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Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients (OPPortuNity)

Primary Purpose

Malnutrition, Surgery

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Parenteral Nutrition
Standard Nutrition Care
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition

Eligibility Criteria

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

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

Sites / Locations

  • Royal Alexandra HospitalRecruiting
  • University of Alberta HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Intervention group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Rate of parenteral nutrition completion
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
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

Length of hospital stay
Duration between hospital admission to discharge
Quality of life: Short Form (SF)-12 questionnaire
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
Body weight measurement in kilograms
Nutrition status
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
Muscle power evaluated by handgrip strength test
Cost-saving
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
Readmission rate within 30 days after discharge
Total energy from parenteral nutrition
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
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
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

Full Information

First Posted
April 15, 2019
Last Updated
July 19, 2023
Sponsor
University of Alberta
Collaborators
Baxter Healthcare Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03926949
Brief Title
Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients
Acronym
OPPortuNity
Official Title
Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients: A Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2019 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
Collaborators
Baxter Healthcare Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Parenteral Nutrition
Other Intervention Name(s)
Olimel 7.6% E 1000 ml
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Nutrition Care
Intervention Description
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 Measure Information:
Title
Rate of parenteral nutrition completion
Description
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
Time Frame
through study completion, an average of 1 year
Title
Postoperative complications evaluated by Clavien-Dindo Classification
Description
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
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Length of hospital stay
Description
Duration between hospital admission to discharge
Time Frame
through study completion, an average of 1 year
Title
Quality of life: Short Form (SF)-12 questionnaire
Description
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.
Time Frame
5-10 days during parenteral nutrition infusion
Title
Body weight
Description
Body weight measurement in kilograms
Time Frame
5-10 days during parenteral nutrition infusion
Title
Nutrition status
Description
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.
Time Frame
5-10 days during parenteral nutrition infusion
Title
Muscle power
Description
Muscle power evaluated by handgrip strength test
Time Frame
5-10 days during parenteral nutrition infusion
Title
Cost-saving
Description
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
Time Frame
through study completion, an average of 1 year
Title
Hospital readmission
Description
Readmission rate within 30 days after discharge
Time Frame
30 days after discharge
Title
Total energy from parenteral nutrition
Description
Total energy from parenteral nutrition measured by total energy in kilocalories per day multiply by total days of parenteral nutrition
Time Frame
5-10 days during parenteral nutrition infusion
Title
Total protein from parenteral nutrition
Description
Total protein from parenteral nutrition measured by total protein in grams per day multiply by total days of parenteral nutrition
Time Frame
5-10 days during parenteral nutrition infusion
Title
Acceptability, appropriateness, and feasibility of intervention measured by Acceptability, Appropriateness, and Feasibility Questionnaire
Description
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
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Narisorn Lakananurak, MD
Phone
17808865718
Email
lakananu@ualberta.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Leah Gramlich, MD
Phone
17809204362
Email
lg3@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leah Gramlich, MD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Narisorn Lakananurak, MD
Phone
7808865718
Email
lakananu@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Leah Gramlich, MD
Phone
7809204362
Email
lg3@ualberta.ca
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Narisorn Lakananurak, MD
Phone
17808865718
Email
lakananu@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Leah Gramlich, MD
Phone
17809204362
Email
lg3@ualberta.ca

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients

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