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Intravenous Nutrition in Hospitalized Patients: Comparison of Two Oils

23. mars 2020 oppdatert av: Johane Allard

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

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).

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

303

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Intralipid
Patients will receive Intralipid, which is the standard lipid emulsion used in the hospital
Legemiddel: Intralipid
soybean oil-based lipid emulsion
Eksperimentell: ClinOleic
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.
Legemiddel: ClinOleic
olive oil-based lipid emulsion

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Prealbumin
Tidsramme: at baseline (day 0) and 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.
at baseline (day 0) and day 10

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Length of stay
Tidsramme: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Length of stay in the hospital and ICU will be recorded. We will record how many days it took,since admission to the hospital, for the patient to be discharged. This is an expected average of 4 weeks of length of stay.
participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Mortality
Tidsramme: participantes will be followed for the duration of hospital stay, an expected average of 4 weeks
We will follow the patients from the day of admission until the day of discharge and record the mortality, if applicable. The expected average of hospital stay is 4 weeks.
participantes will be followed for the duration of hospital stay, an expected average of 4 weeks
Body mass index
Tidsramme: Baseline(day 0), day 10 and last day of PN (expected after an average of 3 weeks)
We will measure weight before, at day 10 and after PN to calculate the BMI at this different points. The last day of PN is whenever the patient is taken off PN. This can vary considerably from patient to patient.
Baseline(day 0), day 10 and last day of PN (expected after an average of 3 weeks)
Infections
Tidsramme: until one week post-PN (averag expected 4 weeks)
we will record the infections the patients develop during PN until one week after PN
until one week post-PN (averag expected 4 weeks)
hand-grip strength
Tidsramme: 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
at baseline (day 0) and day 10 of PN
mid-arm circumference
Tidsramme: at baseline (day0) and day 10
This is a rough indicator of body fat
at baseline (day0) and day 10
Subjective global assessment (SGA)
Tidsramme: 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
at baseline (day 0) and day 10
Antibiotic days
Tidsramme: until one week post PN
we will record antibiotic days from the start of PN until one week after PN is discontinued
until one week post PN
high sensitivity C-reactive Protein (hs-CRP)
Tidsramme: 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
Baseline (day 0) and day 10
Red blood cell fatty acid composition
Tidsramme: Baseline (day 0) and 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
Baseline (day 0) and day 10

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Johane Allard

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2013

Primær fullføring (Faktiske)

1. desember 2019

Studiet fullført (Faktiske)

1. desember 2019

Datoer for studieregistrering

Først innsendt

17. juli 2013

Først innsendt som oppfylte QC-kriteriene

11. september 2013

Først lagt ut (Anslag)

17. september 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

25. mars 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. mars 2020

Sist bekreftet

1. mars 2020

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CAPCR ID: 13-5807

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