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The Effect of Intravenous Nutrition in Patients Undergoing Abdominal Surgery

THE PROTEIN SPARING EFFECT OF PERIOPERATIVE NUTRITION: How Important is the Patient's Catabolic State Before Surgery and do we Need Glucose?

Loss of muscle protein and mass are the main causes of fatigue after bowel surgery which may result in a longer hospital stay and a higher rate of complications. This problem is especially important for patients after surgery for bowel cancer because cancer itself causes a waste of muscle protein. Anesthesiologists can decrease these negative effects of surgery by choosing the type of pain treatment (analgesia) and by giving nutrition (sugar and protein). Our group recently observed that optimal pain relief with epidural catheters (these are placed in the so called epidural space, which lies between the spine and the skin of the back) in combination with a low calorie protein diet intravenously (through the vein) maintains the body's protein stores after bowel surgery.

The goal of our new research program is to find out whether this protein saving effect depends on how protein depleted the patient is before surgery. In other words we would like to answer the question: do cancer patients who show protein wasting before the operation benefit more from feeding than patients who show no signs of protein wasting? A second goal of this program is to find out if we need to use sugar as part of the diet or whether the infusion of protein alone is sufficient. Just giving protein would make feeding not only easier but also would avoid the increase in the patient's own blood sugar during and after the operation, which typically occurs when sugar is given intravenously during that period.

Studieoversikt

Detaljert beskrivelse

  1. Goals The overall goal of perioperative nutrition support is to abolish protein wasting and to promote anabolic processes by directing amino acids into protein synthesis rather than oxidation. Protein repletion and enhancement of anabolism appear to be particularly important in cancer patients who enter major abdominal surgery in a catabolic state.
  2. Objectives The objectives of this research program are

    • to examine whether the anabolic effects of hypocaloric nutrition depend on the degree of catabolism before the operation and thus identify patients who benefit the most from perioperative nutrition support (study I)
    • to investigate whether excluding glucose from hypocaloric nutrition, i.e. infusing an isonitrogenous amount of amino acids without glucose avoids hyperglycemia and, thus, accentuates the patient's anabolic response to feeding (study II).

In order to confirm the validity of our assumptions we will perform two consecutive studies in two distinct patient populations. For the assessment of the patients' catabolic state and obtaining insight into the biochemical mechanisms, whereby the effects of nutrition are mediated, stable isotope tracer kinetics will be applied. Using primed continuous infusions of L-[1-13C]leucine and [6,6-2H2]glucose we will quantitate the whole body dynamics of protein and glucose metabolism, i.e. protein breakdown, amino acid oxidation, protein synthesis, glucose production and glucose uptake before and after surgery. A positive protein balance (difference between protein synthesis and protein breakdown) will be used as an indicator of anabolism. Anabolic processes at the organ level (liver, muscle), i.e. fractional synthesis rates of the acute phase proteins albumin and fibrinogen and muscle protein synthesis will be determined using L-[2H5]phenylalanine infusions. Skeletal muscle protein catabolism will be characterized by measuring the mRNA expression of ubiquitin and two of its key ligases in muscle (MAFbx/atrogen-1 and MuRF-1).

Studietype

Intervensjonell

Registrering (Faktiske)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiesteder

    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • Royal Victoria Hospital, McGill University Health Centre

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:

  • American Society of Anesthesiologists <3
  • colorectal surgery for non-metastatic colorectal carcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy, sigmoid resection
  • ability to give informed consent

Exclusion Criteria:

  • signs of severe malnutrition or obesity: body mass index <18 or >25 >10% involuntary body weight loss over the preceding 6 months serum albumin <21 g/L
  • significant cardiorespiratory, hepatic, renal and neurological disease
  • ingestion of drugs known to affect protein, glucose and lipid metabolism (for example steroids)
  • musculoskeletal or neuromuscular disease
  • severe anemia (hemoglobin <10 g/dL)
  • pregnancy
  • history of severe sciatica or back surgery or other conditions which
  • contraindicate the use of epidural catheters

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Glucose and amino acids
Perioperative nutrition with glucose and amino acids
Glukose og aminosyrer intravenøst ​​med start 20 timer før operasjonen til andre postoperative dag. Glukose gir 50 % og aminosyrer 20 % av hver pasients målte hvileenergiforbruk.
Aktiv komparator: Amino acids only
Perioperative nutrition with amino acids only
Amino acids intravenously starting 20 hours before the operation until the second postoperative day. Amino acids providing 20% of each patient's measured resting energy expenditure.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
proteinbalanse
Tidsramme: to dager etter operasjonen
to dager etter operasjonen

Sekundære resultatmål

Resultatmål
Tidsramme
albumin synthesis
Tidsramme: two days after surgery
two days after surgery
fibrinogen synthesis
Tidsramme: two days after surgery
two days after surgery
total plasma protein synthesis
Tidsramme: two days after surgery
two days after surgery
mRNA expression of ubiquitin
Tidsramme: two days after surgery
two days after surgery

Samarbeidspartnere og etterforskere

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

Etterforskere

  • Hovedetterforsker: Thomas Schricker, MD PhD, Department of Anaesthesia, McGill University Health Centre

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

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

1. november 2009

Primær fullføring (Faktiske)

1. juni 2011

Studiet fullført (Faktiske)

1. juli 2011

Datoer for studieregistrering

Først innsendt

9. august 2011

Først innsendt som oppfylte QC-kriteriene

10. august 2011

Først lagt ut (Anslag)

11. august 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

11. august 2011

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. august 2011

Sist bekreftet

1. august 2011

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • CIHR-2011

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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