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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
- 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.
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).
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Quebec
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Montreal, Quebec, Canada, H3A 1A1
- Royal Victoria Hospital, McGill University Health Centre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: Glucose and amino acids
Perioperative nutrition with glucose and amino acids
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Glucosio e aminoacidi per via endovenosa a partire da 20 ore prima dell'intervento fino al secondo giorno postoperatorio.
Il glucosio fornisce il 50% e gli amminoacidi il 20% del dispendio energetico misurato a riposo di ciascun paziente.
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Comparatore attivo: Amino acids only
Perioperative nutrition with amino acids only
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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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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equilibrio proteico
Lasso di tempo: due giorni dopo l'intervento
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due giorni dopo l'intervento
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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albumin synthesis
Lasso di tempo: two days after surgery
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two days after surgery
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fibrinogen synthesis
Lasso di tempo: two days after surgery
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two days after surgery
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total plasma protein synthesis
Lasso di tempo: two days after surgery
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two days after surgery
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mRNA expression of ubiquitin
Lasso di tempo: two days after surgery
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two days after surgery
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Thomas Schricker, MD PhD, Department of Anaesthesia, McGill University Health Centre
Pubblicazioni e link utili
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
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Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- CIHR-2011
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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