Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

NCT01943409 | Completed Phase 4 Results

• 1 other identifier: CAPCR ID: 13-5807
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

Brief Summary

Intravenous nutrition is an important therapy for the recovery of many patients. It is indicated when the patients cannot take food by mouth or use their intestines for feeding. It is important to indicate it in the appropriate setting because it's not free of complications and is a costly treatment. Some of the complications are: elevated blood sugar or lipids, elevated liver function tests, infection of the catheter or device used to administer intravenous nutrition. Intravenous nutrition is composed by proteins, lipids, carbohydrates (sugar in the form of glucose) and vitamins. Until recently, Intralipid, a soybean oil-based lipid emulsion was the only lipid available in Canada for this kind of nutrition. Since 2010, a new lipid emulsion (ClinOleic) based on olive-oil has been approved by Health Canada for use in intravenous nutrition. There is an increasing need for hospitals to evaluate the quality of intravenous nutrition administered to hospitalized patients in terms of: assessing indications, prescription, complications, clinical results and costs. The objective of this study is to determine if intravenous nutrition prescribed in hospitalized patients is indicated following existing guidelines in terms of timing of nutrition support, prescription, monitoring and whether it is associated with complications. In addition, length of stay and mortality will be assessed. Also, we will evaluate nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion (Intralipid) compared to those of patients receiving olive oil-based lipid emulsion (ClinOleic).

Conditions

Obstruction; Cancer; Ileus; Malnutrition; Surgery

Keywords

Parenteral nutrition; lipid emulsion; Intralipid; ClinOleic; Inflammation; Infection; Bloodstream Infection; length of stay; mortality

Outcome Measures

Primary Outcomes (1)

• Prealbumin

  prealbumin is an hepatic protein that is used in the diagnosis of malnutrition. It has a short half-life so any changes in nutritional status can rapidly be represented by prealbumin levels.

  at day 10

Secondary Outcomes (8)

• Length of Stay

  participants will be followed for the duration of hospital stay up to one year

• Mortality

  participantes will be followed for the duration of hospital stay for up to 1 year

• Infections

  until one week post-PN up to 1 year

• Change in Hand-grip Strength

  at baseline (day 0) and day 10 of PN

• Change in Mid-arm Circumference

  at baseline (day0) and day 10

Study Arms (2)

Intralipid

ACTIVE COMPARATOR

Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital

Drug: Intralipid

ClinOleic

EXPERIMENTAL

Patients that are randomized to receive ClinOleic as a lipid emulsion in their PN, instead of Intralipid. ClinOleic is approved by Health Canada. The amount of calories from the lipid emulsion will be equivalent in the standard of care group and in the ClinOleic group.

Drug: ClinOleic

Interventions

Intralipid DRUG

soybean oil-based lipid emulsion

Intralipid

ClinOleic DRUG

olive oil-based lipid emulsion

ClinOleic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients 18 years or older
• Patients with PN during their hospitalization
• Patients hospitalized in medical, surgical or ICU wards
• Signed informed consent either from the patient, their legally authorized representative or a direct family member

You may not qualify if:

• Patients without PN during their hospitalization

Sponsors & Collaborators

• Johane Allard: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Bites and Stings; Neoplasms; Ileus; Malnutrition; Hyperphagia; Inflammation; Infections; Sepsis

Interventions

soybean oil, phospholipid emulsion; ClinOleic

Condition Hierarchy (Ancestors)

Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Systemic Inflammatory Response Syndrome

Results Point of Contact

• Title: Scientific Associate
• Organization: Toronto General Hospital

kschweng@uhnresearch.ca

4163405159

Study Officials

• Johane P Allard, MD, FRCPC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine, Director-Division of Gastroenterology

Study Record Dates

• First Submitted: July 17, 2013
• First Posted: September 17, 2013
• Study Start: July 1, 2013
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: February 3, 2025
• Results First Posted: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)