MalnutritionOPPortuNityNCT03926949
Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients
A study testing Parenteral Nutrition and Standard Nutrition Care in people with Malnutrition and Surgery, run by University of Alberta at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malnutrition, Surgery
- What is being tested?
- Parenteral Nutrition and Standard Nutrition Care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesCanada
- Study dates
- 30 Oct 2019to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
About this study
Official title: Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients: A Feasibility Study
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
- Being tested
- Parenteral Nutrition, Standard Nutrition Care
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parenteral NutritionOther
Also called Olimel 7.6% E 1000 ml
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | 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. Receives: Other: Parenteral Nutrition |
| Control group | Other | 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 Receives: Other: Standard Nutrition Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: through study completion, an average of 1 year
Secondary outcomes (10)
Length of hospital stay
Duration between hospital admission to discharge
Measured: through study completion, an average of 1 year
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.
Measured: 5-10 days during parenteral nutrition infusion
Body weight
Body weight measurement in kilograms
Measured: 5-10 days during parenteral nutrition infusion
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.
Measured: 5-10 days during parenteral nutrition infusion
Muscle power
Muscle power evaluated by handgrip strength test
Measured: 5-10 days during parenteral nutrition infusion
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
Measured: through study completion, an average of 1 year
Hospital readmission
Readmission rate within 30 days after discharge
Measured: 30 days after discharge
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
Measured: 5-10 days during parenteral nutrition infusion
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
Measured: 5-10 days during parenteral nutrition infusion
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start30 Oct 2019
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Leah Gramlich, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926949
- Sponsor's protocol ID
- 19G2208
- Acronym
- OPPortuNity
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2019
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients: A Feasibility Study
- ClinicalTrials.gov ID
- NCT03926949
- Acronym / sponsor ID
- OPPortuNity / 19G2208
- Conditions
- Malnutrition, Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Parenteral NutritionParticipants 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 | Other | Other: Standard Nutrition CareParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parenteral NutritionAlso: Olimel 7.6% E 1000 mlOlimel 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. | Other | Intervention group |
| Standard Nutrition CareParticipants 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. | Other | Control group |
Primary outcome
Rate of parenteral nutrition completion
Time frame: 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
Time frame: 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
10 secondary outcomes
Length of hospital stay
Time frame: through study completion, an average of 1 year
Quality of life: Short Form (SF)-12 questionnaire
Time frame: 5-10 days during parenteral nutrition infusion
Body weight
Time frame: 5-10 days during parenteral nutrition infusion
Nutrition status
Time frame: 5-10 days during parenteral nutrition infusion
Muscle power
Time frame: 5-10 days during parenteral nutrition infusion
Cost-saving
Time frame: through study completion, an average of 1 year
Hospital readmission
Time frame: 30 days after discharge
Total energy from parenteral nutrition
Time frame: 5-10 days during parenteral nutrition infusion
Total protein from parenteral nutrition
Time frame: 5-10 days during parenteral nutrition infusion
Acceptability, appropriateness, and feasibility of intervention measured by Acceptability, Appropriateness, and Feasibility Questionnaire
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah Gramlich, MD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parenteral Nutrition and Standard Nutrition Care in people with Malnutrition and Surgery, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of parenteral nutrition completion (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.