Malnutrition, Surgery
Conditions
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.
Interventions
OTHERParenteral 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.
OTHERStandard 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.
Sponsors
University of Alberta
Baxter Healthcare Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of parenteral nutrition completion | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | through study completion, an average of 1 year | Duration between hospital admission to discharge |
| Quality of life: Short Form (SF)-12 questionnaire | 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 | 5-10 days during parenteral nutrition infusion | Body weight measurement in kilograms |
| Nutrition status | 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 | 5-10 days during parenteral nutrition infusion | Muscle power evaluated by handgrip strength test |
| Cost-saving | 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 | 30 days after discharge | Readmission rate within 30 days after discharge |
| Total energy from parenteral nutrition | 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 | 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 | 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 |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORLeah Gramlich, MD
University of Alberta
Outcome results
None listed