Recruiting

Parenteral Nutrition

Sponsor:

University of Alberta

Code:

NCT03926949

Conditions

Malnutrition

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Parenteral Nutrition

Standard Nutrition Care

Study Details

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.

Conditions

Malnutrition

Surgery

Study ID

NCT03926949

Start date

Oct 30, 2019

Status verified date

Aug, 2025

Completion date

Jul 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention group

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.

other: Control group

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

Interventions

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.

Primary outcome measure

  • Rate of parenteral nutrition completion [ Time Frame: through study completion, an average of 1 year ]
  • Postoperative complications evaluated by Clavien-Dindo Classification [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Narisorn Lakananurak, MD

17808865718lakananu@ualberta.ca

Locations

Royal Alexandra Hospital

Recruiting

Edmonton, Alberta, Canada, T5H 3V9

Contacts

Narisorn Lakananurak, MD

7808865718lakananu@ualberta.ca

University of Alberta Hospital

Recruiting

Edmonton, Alberta, Canada, T6G 2B7

Contacts

Narisorn Lakananurak, MD

17808865718lakananu@ualberta.ca

More Information

Sponsor

University of Alberta

Last update posted

Aug 21, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alberta on 2025-08-21.