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NCT Number: NCT01943409

Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

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).

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Key information

Conditions

Obstruction Bites and Stings Cancer Chemically-Induced Disorders Digestive System Diseases Gastrointestinal Diseases Hyperphagia Ileus Infections Inflammation Intestinal Diseases Intestinal Obstruction Malnutrition Neoplasms Nutrition Disorders Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Poisoning Sepsis Signs and Symptoms Signs and Symptoms, Digestive Surgery Systemic Inflammatory Response Syndrome Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

About this study

Until recently, Intralipid, a soybean oil-based lipid emulsion, has been the only available lipid for intravenous use in Canada. In 2010, ClinOleic, a new, predominantly olive oil based emulsion, has been approved by Health Canada as an alternative lipid.

There is an increasing need for hospitals to do quality-assurance studies for in-patient parenteral nutrition (PN) to assess indications, PN prescription, complications, clinical outcomes and costs. The only in-patient population that is well studied is the intensive care unit (ICU) population. Several meta-analyses showed that PN was associated with higher infection rate, longer length of stay and higher mortality when compared with enteral nutrition. Results from these and other studies were the basis for the Canadian ICU Guidelines.

The aim of this study is to determine if PN prescribed in in-patients is indicated, appropriately following existing guidelines in terms of timing of nutrition support, prescription and monitoring and, whether it is associated with complications. In addition, clinical outcomes such as length of stay and mortality will be assessed. Also, we will evaluate metabolic, nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion compared to those of patients receiving olive oil-based lipid emulsion.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • • Patients without PN during their hospitalization

Treatment and study plan

Intralipid

Drug

soybean oil-based lipid emulsion

Clinoleic

Drug

olive oil-based lipid emulsion

Primary outcomes

  1. Prealbumin

    Time frame: at day 10

    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.

Secondary outcomes

  1. Length of Stay

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

    Length of stay in the hospital and ICU will be recorded for 1 year

  2. Mortality

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

    We will follow the patients from the day of admission until the day of discharge and record the mortality for 1 year

  3. Infections

    Time frame: until one week post-PN up to 1 year

    we will record the infections the patients develop during PN until one week after PN for 1 year

  4. Change in Hand-grip Strength

    Time frame: at baseline (day 0) and day 10 of PN

    We will measure hand grip strength at baseline (day0) and at day 10 of PN. This is a test that measures the strength of the hand and forearm muscles and is often used as a general test of strength

  5. Change in Mid-arm Circumference

    Time frame: at baseline (day0) and day 10

    This is a rough indicator of body fat

  6. Subjective Global Assessment (SGA): Number Who Improved

    Time frame: at baseline (day 0) and day 10

    is a bedside method that assesses the risk of malnutrition and identifies which patient will benefit best from nutrition support

  7. Change in High Sensitivity C-reactive Protein (Hs-CRP)

    Time frame: Baseline (day 0) and day 10

    hs-CRP is a marker of inflammation, we will measure this parameter at baseline and after 10 days of PN

  8. Red Blood Cell Fatty Acid Composition: Linoleic

    Time frame: day 10

    Red blood cell fatty acid composition, particularly the essential fatty acids (linoleic acid and alpha-linolenic acid) will be measured to assess presence/absence of essential fatty acid deficiency

Sponsors and collaborators

Lead sponsor

Johane Allard

Other

Registry information

Official study title

Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2013
Registry last updated
Feb 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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