ArticleTrials2007
PROUD: effects of preoperative long-term immunonutrition in patients listed for liver transplantation.
Article in Trials, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00495859 (Randomized Controlled Double Blind Multi-Center Clinical Trial to Assess the Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation), which is not on this map. Cited by 4 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Randomized Controlled Double Blind Multi-Center Clinical Trial to Assess the Effects of Preoperative Long-Term Immunonutrition in Patients Listed for Liver Transplantation
Who cites it
4 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Nutritional interventions for liver-transplanted patients.The Cochrane database of systematic reviews · 2012Pooled it
- Nutritional support for liver disease.The Cochrane database of systematic reviews · 2012Pooled it
- Posttransplant sarcopenia: an underrecognized early consequence of liver transplantation.Digestive diseases and sciences · 2013Review
- Effects of a preconditioning oral nutritional supplement on pig livers after warm ischemia.HPB surgery : a world journal of hepatic, pancreatic and biliary surgery · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPatients with end stage liver disease are characteristically malnourished which is associated with poor outcome. Formulas enriched with arginine, omega-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/
designA 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 improved 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, intraabdominal abscess, sepsis, line sepsis, wound infection, and urinary tract infection), acute and chronic rejection, and mortality. DISCUSSION: Formulas enriched with arginine, omega-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.
trial registrationClinicalTrials.gov NCT00495859.
Identifiers
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Registered trials
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