- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00495859
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
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Baden-Württemberg
-
Heidelberg, Baden-Württemberg, Tyskland, 69120
- Rekruttering
- Department of Surgery, Ruprecht-Karls University
-
Kontakt:
- Peter Schemmer, MD
- Telefonnummer: +4962215636500
- E-mail: peter.schemmer@med.uni-heidelberg.de
-
Kontakt:
- Arash Nickkholgh, MD
- Telefonnummer: +4962215638584
- E-mail: arash.nickkholgh@med.uni-heidelberg.de
-
Ledende efterforsker:
- Peter Schemmer, MD
-
Underforsker:
- Arash Nickkholgh, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Firedobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 1
Study group will receive formula enriched with arginine, ω-3 fatty acids, and nucleotides once daily
|
food for special medical purpose (FSMP)
Andre navne:
|
Aktiv komparator: 2
controls receive an isocaloric isonitrogenous non-specific nutritional support
|
an isocaloric isonitrogenous non-specific nutritional support
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
improved patients' nutritional and physiological status, fatigue score, as well as patients' health related quality of life.
Tidsramme: while in the waiting list for liver transplantation
|
while in the waiting list for liver transplantation
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
enhanced anabolic recovery after transplantation as shown by reduced post-transplant morbidities and mortalities
Tidsramme: the first 12 posttransplant weeks
|
the first 12 posttransplant weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Peter Schemmer, MD, Department of Surgery, Ruprecht-Karls University of Heidelberg, Germany
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- PROUD
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Immunonutrition
-
Memorial Sloan Kettering Cancer CenterAktiv, ikke rekrutterendeDebulking kirurgi for ovariecancerForenede Stater