← Back to Search

Other

Preoperative Parenteral Nutrition for Malnutrition (OPPortuNity Trial)

N/A

Recruiting

Led By Leah Gramlich, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

OPPortuNity Trial Summary

This trial will test whether pre-operative parenteral nutrition given outpatient-style is feasible and improves outcomes for malnourished patients undergoing major surgery.

Who is the study for?

This trial is for adults over 18 who are malnourished and about to have major surgery. They must be at risk of malnutrition as per the Canadian Nutrition Screening Tool and confirmed by subjective global assessment. It's not for pregnant individuals, those with severe systemic diseases, undergoing minor or laparoscopic surgery, diabetics, or patients with planned palliative treatment.Check my eligibility

What is being tested?

The study tests if giving nutrition directly into a vein (Parenteral Nutrition) outside the hospital before surgery can help improve patient outcomes compared to standard nutrition care. This approach could potentially reduce hospital stays and costs while avoiding hospital-acquired infections.See study design

What are the potential side effects?

While specific side effects aren't listed here, parenteral nutrition generally may cause complications like infection at the infusion site, liver problems, blood sugar imbalances or reactions to the nutrient solution.

OPPortuNity Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Postoperative complications evaluated by Clavien-Dindo Classification

Rate of parenteral nutrition completion

Secondary outcome measures

Acceptability, appropriateness, and feasibility of intervention measured by Acceptability, Appropriateness, and Feasibility Questionnaire

Body weight

Cost-saving

+7 more

OPPortuNity Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Control groupExperimental Treatment1 Intervention

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

Group II: Intervention groupActive Control1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

889 Previous Clinical Trials

385,074 Total Patients Enrolled

6 Trials studying Malnutrition

1,996 Patients Enrolled for Malnutrition

Baxter Healthcare CorporationIndustry Sponsor

315 Previous Clinical Trials

200,008 Total Patients Enrolled

5 Trials studying Malnutrition

2,288 Patients Enrolled for Malnutrition

Leah Gramlich, MDPrincipal InvestigatorUniversity of Alberta

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment recruiting participants at the present time?

"Affirmative. The clinical trial registry hosted on clinicaltrials.gov attests to the fact that this medical study, which was originally posted on October 30th 2019, is currently recruiting participants. There are 60 positions available at two distinct locations."

Answered by AI

What is the ultimate purpose of this research trial?

"This clinical trial, with an anticipated duration of one year, is undertaking measurement to evaluate post-operative complications using the Clavien-Dindo Classification. Secondary objectives include assessing total protein intake from parenteral nutrition sources, patient's overall nutritional status according to the Patient-generated subjective global assessment (PGSGA) and length of hospital stay. The PGSGA divides patients into three groups based on weight loss, food consumption, gastrointestinal symptoms and physical examination; scoring 0 - 55 where low scores indicate higher nutrition status."

Answered by AI

How many people have opted to join in this experiment thus far?

"Affirmative, clinicaltrials.gov data affirms that this study is currently enrolling participants. This medical experiment was posted on October 30th 2019 and last updated July 18th 2022; it aims to recruit 60 patients from two separate sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients

2019. "Outpatient Preoperative Parenteral Nutrition in Malnourished Surgical Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03926949.