Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients
OPPortuNity
1 other identifier
interventional
60
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2019
CompletedFirst Posted
Study publicly available on registry
April 25, 2019
CompletedStudy Start
First participant enrolled
October 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2026
August 21, 2025
August 1, 2025
6.8 years
April 15, 2019
August 19, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (10)
Length of hospital stay
through study completion, an average of 1 year
Quality of life: Short Form (SF)-12 questionnaire
5-10 days during parenteral nutrition infusion
Body weight
5-10 days during parenteral nutrition infusion
Nutrition status
5-10 days during parenteral nutrition infusion
Muscle power
5-10 days during parenteral nutrition infusion
- +5 more secondary outcomes
Study Arms (2)
Intervention group
ACTIVE COMPARATORParticipants 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.
Control group
OTHERParticipants 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
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Albertalead
- Baxter Healthcare Corporationcollaborator
Study Sites (2)
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leah Gramlich, MD
University of Alberta
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 15, 2019
First Posted
April 25, 2019
Study Start
October 30, 2019
Primary Completion (Estimated)
July 31, 2026
Study Completion (Estimated)
July 31, 2026
Last Updated
August 21, 2025
Record last verified: 2025-08