Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients

Surgery Clinical Trial

— OPPortuNity  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03926949
• Other study ID #: 19G2208
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: July 31, 2024

Study information

• Verified date: July 2023
• Source: University of Alberta
• Contact: Narisorn Lakananurak, MD
• Phone: 17808865718
• Email: lakananu[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malnutrition
• Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Royal Alexandra Hospital	Edmonton	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	Baxter Healthcare Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	through study completion, an average of 1 year
Primary	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	through study completion, an average of 1 year
Secondary	Length of hospital stay	Duration between hospital admission to discharge	through study completion, an average of 1 year
Secondary	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.	5-10 days during parenteral nutrition infusion
Secondary	Body weight	Body weight measurement in kilograms	5-10 days during parenteral nutrition infusion
Secondary	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.	5-10 days during parenteral nutrition infusion
Secondary	Muscle power	Muscle power evaluated by handgrip strength test	5-10 days during parenteral nutrition infusion
Secondary	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	through study completion, an average of 1 year
Secondary	Hospital readmission	Readmission rate within 30 days after discharge	30 days after discharge
Secondary	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	5-10 days during parenteral nutrition infusion
Secondary	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	5-10 days during parenteral nutrition infusion
Secondary	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	through study completion, an average of 1 year