Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation (PROUD)
Randomized Controlled Double Blind Multi-Center Clinical Trial to Assess the Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Background. Patients with end stage liver disease characteristically are malnourished which is associated with poor outcome. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides, "immunonutrients", potentially improve their nutritional status. This study is designed to evaluate the clinical outcome of long-term "immunonutrition" of patients with end-stage liver disease while on the waiting list for liver transplantation.
Methods / design. A randomized controlled double blind multi-center clinical trial with two parallel groups comprising a total of 142 newly registered patients for primary liver transplantation has been designed to assess the safety and efficacy of the long-term administration of ORAL IMPACT®, an "immunonutrient" formula, while waiting for a graft. Patients will be enrolled the day of registration on the waiting list for liver transplantation. Study ends on the day of transplantation. Primary endpoints include patients' nutritional and physiological status, as measured by mid-arm muscle area, triceps skin fold thickness, grip strength, and fatigue score, as well as patients' health related quality of life. Furthermore, patients will be followed for 12 postoperative weeks to evaluate anabolic recovery after transplantation as shown by reduced post-transplant mechanical ventilation, hospital stay, wound healing, infectious morbidities (pneumonia, intra-abdominal abscess, sepsis, line sepsis, wound infection, and urinary tract infection), acute and chronic rejection, and mortality.
Discussion. Formulas enriched with arginine, ω-3 fatty acids, and nucleotides have been proven to be beneficial in reducing postoperative infectious complications and length of hospital stay among the patients undergoing elective gastrointestinal surgery. Possible mechanisms include downregulation of the inflammatory responses to surgery and immune modulation rather than a sole nutritional effect.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Baden-Württemberg
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Heidelberg, Baden-Württemberg, Deutschland, 69120
- Rekrutierung
- Department of Surgery, Ruprecht-Karls University
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Kontakt:
- Peter Schemmer, MD
- Telefonnummer: +4962215636500
- E-Mail: peter.schemmer@med.uni-heidelberg.de
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Kontakt:
- Arash Nickkholgh, MD
- Telefonnummer: +4962215638584
- E-Mail: arash.nickkholgh@med.uni-heidelberg.de
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Hauptermittler:
- Peter Schemmer, MD
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Unterermittler:
- Arash Nickkholgh, MD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Men and women between 18 and 68 years of age
- Scheduled for first liver transplantation
- Written informed consent
- Protein-calorie malnutrition: Mid-arm muscle area (MAMA) <85% standard
Exclusion Criteria:
- Patients < 18 and > 68 years
- Pregnant or nursing women
- History of hypersensitivity to arginine, ω-3 fatty acids, or nucleotides
- Inability to take oral nutrition
- Patients with fulminant or subacute hepatic failure requiring urgent transplantation
- Mental condition rendering the subject incapable to understand the nature, scope, and consequences of the trial
- Simultaneous participation in another clinical trial
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: 1
Study group will receive formula enriched with arginine, ω-3 fatty acids, and nucleotides once daily
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food for special medical purpose (FSMP)
Andere Namen:
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Aktiver Komparator: 2
controls receive an isocaloric isonitrogenous non-specific nutritional support
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an isocaloric isonitrogenous non-specific nutritional support
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life.
Zeitfenster: while in the waiting list for liver transplantation
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while in the waiting list for liver transplantation
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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enhanced anabolic recovery after transplantation as shown by reduced post-transplant morbidities and mortalities
Zeitfenster: the first 12 posttransplant weeks
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the first 12 posttransplant weeks
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Peter Schemmer, MD, Department of Surgery, Ruprecht-Karls University of Heidelberg, Germany
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- PROUD
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