Preoperative Parenteral Nutrition for Malnutrition

(OPPortuNity Trial)

Recruiting at 1 trial location

Overseen By Leah Gramlich, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Must be taking: Parenteral nutrition

Disqualifiers: Minor surgery, Pregnancy, Severe diseases, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether providing nutrition through a vein (parenteral nutrition) before surgery can benefit malnourished patients. It aims to determine if this method can be administered outside the hospital and improve postoperative recovery. Participants will either receive vein nutrition at an outpatient clinic or receive nutrition advice from a dietitian. The trial seeks individuals diagnosed as malnourished who are undergoing major surgery, excluding those with diabetes or undergoing minor procedures.

As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance surgical outcomes for malnourished patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that parenteral nutrition is safe for malnourished surgical patients?

Research has shown that administering nutrients like carbohydrates, fats, and protein directly into a vein, known as parenteral nutrition (PN), is generally safe for undernourished patients needing surgery. One study found that using PN before surgery in these patients improved recovery and reduced complications compared to those who did not receive PN.

Another study highlighted that PN is safe for patients with malnutrition caused by Crohn's disease, a type of inflammatory bowel disease, showing similar positive results to those who did not receive PN.

Overall, PN is well-tolerated, with most patients not experiencing serious side effects. While some might feel mild discomfort at the infusion site, serious problems are rare.

These findings support the safety of PN, especially for those requiring extra nutrition before surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Preoperative parenteral nutrition is unique because it delivers essential nutrients directly into the bloodstream, bypassing the digestive system. This method is particularly beneficial for patients who are malnourished and may not absorb nutrients well through traditional dietary means. Unlike the standard nutrition therapy, which relies on dietary adjustments and supplements, parenteral nutrition can provide immediate nutritional support, potentially improving patients' readiness for surgery within just a few days. Researchers are excited about this approach because it could enhance surgical outcomes by optimizing patients' nutritional status more rapidly and effectively.

What evidence suggests that outpatient pre-operative parenteral nutrition is effective for malnutrition in surgical patients?

Research has shown that providing nutrition directly into the bloodstream, known as parenteral nutrition (PN), can aid malnourished patients undergoing surgery. Studies have found that malnutrition often leads to worse outcomes post-surgery. PN supplies essential nutrients like carbohydrates, fats, and proteins directly into the body, which is especially beneficial for patients unable to obtain sufficient nutrition through normal eating. In this trial, participants in the intervention group will receive PN at home before surgery to assess its impact on recovery and complication reduction. Meanwhile, the control group will receive nutrition therapy from registered dietitians. Early results suggest that enhancing nutrition before surgery could be crucial for better recovery in malnourished patients. ^{3 6 7 8 9}

Who Is on the Research Team?

Leah Gramlich, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I am scheduled for treatment to relieve symptoms, not cure my disease.

Patients with severe systemic diseases defined by American Society of Anesthesiologists (ASA) classification III to V

I have diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Preoperative Parenteral Nutrition

Participants receive parenteral nutrition (Olimel 7.6% E 1000 ml) infused over 4-5 hours at an outpatient infusion clinic for 5-10 days within 14 days prior to surgery

5-10 days

Daily visits to outpatient infusion clinic

Surgery and Immediate Postoperative Care

Participants undergo surgery and receive immediate postoperative care

Varies based on individual surgical and recovery needs

Follow-up

Participants are monitored for safety and effectiveness after treatment, including postoperative complications and hospital readmission rates

30 days

Regular follow-up visits and assessments

What Are the Treatments Tested in This Trial?

Interventions

• Parenteral Nutrition
• Standard Nutrition Care

Trial Overview 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.

How Is the Trial Designed?

Group I: Control group Experimental Treatment 1 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 group Active Control 1 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.

Parenteral Nutrition is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Parenteral Nutrition for:

• Malnutrition in surgical patients
• Preoperative nutritional support

Approved in United States as Parenteral Nutrition for:

• Malnutrition in surgical patients
• Preoperative nutritional support
• Postoperative nutritional support

Approved in Canada as Parenteral Nutrition for:

• Malnutrition in surgical patients
• Preoperative nutritional support

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Baxter Healthcare Corporation

Industry Sponsor

Trials

328

Recruited

203,000+

Dr. Heather Knight

Baxter Healthcare Corporation

Chief Medical Officer

MD

Brent Shafer

Baxter Healthcare Corporation

Chief Executive Officer

Bachelor's degree in Business Administration

Published Research Related to This Trial

Preoperative nutritional support, particularly total parenteral nutrition (TPN) or total enteral nutrition (TEN) given for 7-15 days, can significantly improve nutritional status and reduce postoperative complications in malnourished patients.

Both TPN and TEN are equally effective in enhancing postoperative outcomes, and initiating these nutritional supports promptly upon admission may lower the risks of morbidity and mortality during surgery, regardless of the patient's initial nutritional status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A critical appraisal of the usefulness of perioperative nutritional support. Campos, AC., Meguid, MM.[2018]

Malnourished patients receiving peripheral parenteral nutrition (PPN) with added micronutrients (multiple vitamins and trace elements) showed lower postoperative inflammation and better recovery outcomes compared to those who did not receive these supplements.

The study indicates that providing adequate micronutrients preoperatively can significantly improve the prognosis for malnourished patients undergoing abdominal surgery, highlighting the importance of comprehensive nutritional support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of preoperative peripheral parenteral nutrition with micronutrients after colorectal cancer patients. Liu, MY., Tang, HC., Hu, SH., et al.[2018]

A total of 12,907 parenteral nutrition incident reports were analyzed, revealing that 83.8% reported no harm, while only 0.002% resulted in severe harm or death, indicating a low frequency of serious incidents.

The study identified that neonates were the most affected group, with administration errors being the most common issue, highlighting the need for improved safety systems for high-risk patients, particularly those under one year old.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National evaluation of harm associated with patient safety incident reports related to the provision of parenteral nutrition to patients, using a national incident reporting system. Mistry, P., Fox, A., Latter, S.[2023]

In a study of 395 malnourished patients undergoing major surgery, total parenteral nutrition (TPN) did not reduce the overall incidence of serious complications compared to those who did not receive TPN, with similar rates of major complications and mortality in both groups.

However, TPN was associated with a higher rate of infectious complications in borderline or mildly malnourished patients, while severely malnourished patients benefited from TPN by experiencing fewer noninfectious complications, suggesting that TPN should primarily be reserved for those who are severely malnourished.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative total parenteral nutrition in surgical patients. [2022]

In a study of 340 patients who underwent pancreaticoduodenectomy, those receiving total parenteral nutrition (TPN) had fewer postoperative complications, such as delayed gastric emptying and pulmonary infections, compared to those receiving early enteral nutrition supplemented with parenteral nutrition (EEN + PN).

Patients in the EEN + PN group experienced longer hospital stays and higher medical costs, suggesting that TPN may be a safer and more effective option for recovery after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early enteral nutrition vs parenteral nutrition following pancreaticoduodenectomy: Experience from a single center. Lu, JW., Liu, C., Du, ZQ., et al.[2018]

Total parenteral nutrition (TPN) is an effective method for providing essential nutrients to patients who cannot eat normally, using a catheter to deliver concentrated nutrients directly into the bloodstream.

While TPN can significantly improve the nutritional status of patients with conditions like severe short bowel syndrome or intestinal fistulas, it carries risks such as infections and metabolic issues, highlighting the need for careful management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total parenteral nutrition. Fleming, CR., McGill, DB., Hoffman, HN., et al.[2019]

A multicenter trial involving 97 chronically hospitalized ICU patients found that both total parenteral nutrition (TPN) and partial parenteral nutrition (PPN) are safe and effective methods for providing nutritional support, with significant improvements in nutritional lab values over 14 days.

While there were no significant differences in clinical outcomes between TPN and PPN, the study highlights the need for better patient selection criteria and monitoring markers to optimize nutritional support for critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison between Total Parenteral Nutrition Vs. Partial Parenteral Nutrition on Serum Lipids Among Chronic Ventilator Dependent Patients; A Multi Center Study. Radpay, R., Poor Zamany Nejat Kermany, M., Radpay, B.[2020]

Total parenteral nutrition (TPN) does not significantly affect the death rate in surgical patients, based on a review of 27 randomized trials involving various surgical patients.

TPN may reduce major complication rates, particularly in malnourished patients, although the results vary based on the quality of the studies and the year they were published.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total parenteral nutrition in the surgical patient: a meta-analysis. Heyland, DK., Montalvo, M., MacDonald, S., et al.[2022]

Preoperative total parenteral nutrition (TPN) for at least 5 days significantly improved nutritional parameters and reduced morbidity and mortality in surgical patients, based on a study of 70 patients.

Patients receiving TPN before surgery had lower rates of major septic complications, indicating that addressing malnutrition prior to surgery can lead to better surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of preoperative total parenteral nutrition on surgery outcomes. Grimes, CJ., Younathan, MT., Lee, WC.[2013]

In a study of 45 patients undergoing major elective upper gastrointestinal surgery, those who received total parenteral nutrition (TPN) before and after surgery (GE group) had significantly lower morbidity (27%) and no mortality, compared to those who started TPN after surgery (GC group) with 100% morbidity and 30% mortality.

The findings suggest that preoperative and postoperative TPN is crucial for patients with severe malnutrition, as it not only reduces complications and mortality but also indicates the importance of careful patient selection for TPN therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Morbidity, mortality, and total parenteral nutrition in esophageal and gastric surgery for benign pathology]. Arenas Márquez, H., Prieto Chávez, E., Hernández Higareda, LA., et al.[2006]

In a study of 145 surgical patients, those who received adequate preoperative total parenteral nutrition (TPN) based on the Prognostic Nutritional Index (PNI) showed a significant reduction in postoperative complications, major sepsis, and mortality compared to those who did not receive TPN.

The study highlights that traditional clinical assessments of nutritional status are insufficient for identifying high-risk patients, emphasizing the importance of using the PNI model to guide nutritional support in surgical candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of operative morbidity and mortality by combined preoperative and postoperative nutritional support. Mullen, JL., Buzby, GP., Matthews, DC., et al.[2019]

A survey of 895 healthcare professionals revealed that while most organizations use a once-daily parenteral nutrition (PN) admixture, many practices do not comply with established safety guidelines, highlighting a need for improved adherence.

Only one-third of organizations utilize electronic PN order entry, and many still require manual transcription, which increases the risk of errors; additionally, 44% of organizations do not track PN-related medication errors, indicating gaps in safety monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A parenteral nutrition use survey with gap analysis. Boullata, JI., Guenter, P., Mirtallo, JM.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9659055/

Parenteral Nutrition Overview - PMC - PubMed Central - NIH Since malnutrition is associated with poor outcomes, nutritional support is indicated in patients who are malnourished or at risk of developing malnutrition [8] ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03926949

Outpatient Preoperative Parenteral Nutrition in ... Many studies have shown a clear association between malnutrition and poor surgical outcomes. Parenteral nutrition (PN) is a nutrition intervention that is given ...

3. nejm.org nejm.org/doi/full/10.1056/NEJM199108223250801

Perioperative Total Parenteral Nutrition in Surgical Patients This study confirms the lack of benefit of TPN in borderline malnourished patients, provides strong evidence against clinically important ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11784791/

Nutritional Optimization of the Surgical Patient: A Narrative ... In this narrative review, we concisely aggregate emerging data to highlight the role of nutritional optimization as a promising, practical perioperative ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S240545771630345X

Assessing the appropriateness of parenteral nutrition use ... Our aim is to assess parenteral nutrition (PN) bag prescription in hospitalized patients and evaluate clinical outcomes linked to PN therapy.

6. sciencedirect.com sciencedirect.com/science/article/pii/S127977072301401X

Comparative outcomes of total parenteral nutrition use in ... A recent Cochrane review has demonstrated that preoperative parenteral nutrition for malnourished surgical candidates results in a significant reduction in post ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30976423/

Pre-operative total parenteral nutrition improves post ... In a subset of malnourished CD patients, TPN is safe and allows comparable operative outcomes to controls ... pre-operative malnutrition; total parenteral ...

8. aspenjournals.onlinelibrary.wiley.com aspenjournals.onlinelibrary.wiley.com/doi/10.1002/ncp.10764

Safety and impact of peripheral parenteral nutrition on nutrient ... Poor nutrition is known to have negative outcomes in hospitalized patients. Hospitalized patients are at risk for developing malnutrition ...

9. mdpi.com mdpi.com/2072-6643/12/5/1244

Preoperative Exclusive Total Parental Nutrition is ... Up to 85% of CD surgical candidates are malnourished due to decreased dietary intake and malabsorption as a consequence of their active disease [8]. Moreover, ...