Clinical trial NCT03926949: Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients
Official title: Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malnutrition
Surgery
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2019-04-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Rate of parenteral nutrition completion
timeFrame: through study completion, an average of 1 year
measure: Postoperative complications evaluated by Clavien-Dindo Classification
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Length of hospital stay
timeFrame: through study completion, an average of 1 year
measure: Quality of life: Short Form (SF)-12 questionnaire
timeFrame: 5-10 days during parenteral nutrition infusion
measure: Body weight
timeFrame: 5-10 days during parenteral nutrition infusion
measure: Nutrition status
timeFrame: 5-10 days during parenteral nutrition infusion
measure: Muscle power
timeFrame: 5-10 days during parenteral nutrition infusion
measure: Cost-saving
timeFrame: through study completion, an average of 1 year
measure: Hospital readmission
timeFrame: 30 days after discharge
measure: Total energy from parenteral nutrition
timeFrame: 5-10 days during parenteral nutrition infusion
measure: Total protein from parenteral nutrition
timeFrame: 5-10 days during parenteral nutrition infusion
measure: Acceptability, appropriateness, and feasibility of intervention measured by Acceptability, Appropriateness, and Feasibility Questionnaire
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Leah Gramlich, MD
role: PRINCIPAL_INVESTIGATOR
References: