Pilot study evaluating the efficacy, tolerance and safety of a peptide-based enteral formula versus a high protein enteral formula in multiple ICU settings (medical, surgical, cardiothoracic).

INTRODUCTION: Predigested, peptide-based enteral formulas are commonly used to promote GI tolerance in critically ill patients, but studies comparing these against polymeric enteral formulas are lacking. We performed a prospective, randomized clinical comparison pilot study to assess safety, tolerance and effectiveness of a peptide-based enteral product. METHODS: Critically ill patients from ICUs, including medical, surgical, and cardiothoracic, were randomized to either of two enteral feeding products: Group A: Peptide-based, high Protein, high omega-3 fat (Vital AF®, Abbott Nutrition); Group B: high protein standard enteral formula (Osmolite®, Abbott Nutrition). Tolerance and comorbidities as well as enteral feeding volume were collected at baseline and then daily for up to 21 days, or until the patient was discharged from the ICU. RESULTS: A total of 49 patients were included, 25 (51%) on group A, 24 (49%) on group B. Adverse events and undesired gastrointestinal events at baseline and mean intake (ml/d and percent of goal) post baseline were not different between the groups. There were significantly fewer days with adverse events (p = 0.0336, odds ratio = 3.02, standard error = 1.60, n = 24 per group) and undesired gastrointestinal events (p = 0.0489, odds ratio = 2.79, standard error = 1.48, n = 24 per group) in group A. There was no difference in other clinical outcomes. CONCLUSION: This pilot study suggests that feeding a peptide-based formula to ICU patients may be associated with a statistically significant reduction in the number of days during which adverse events occurred as compared to a standard formula.

Combination of liver biopsy with MELD-XI scores for post-transplant outcome prediction in patients with advanced heart failure and suspected liver dysfunction.

BACKGROUND: Functional and structural liver abnormalities may be found in patients with advanced heart failure (HF). The Model of End-Stage Liver Disease Excluding INR (MELD-XI) score allows functional risk stratification of HF patients on and off anti-coagulation awaiting heart transplantation (HTx), but these scores may improve or worsen depending on bridging therapies and during time on the waiting list. Liver biopsy is sometimes performed to assess for severity of fibrosis. Uncertainty remains whether biopsy in addition to MELD-XI improves prediction of adverse outcomes in patients evaluated for HTx. METHODS: Sixty-eight patients suspected of advanced liver disease underwent liver biopsy as part of their HTx evaluation. A liver risk score (fibrosis-on-biopsy + 1) × MELD-XI was generated for each patient. RESULTS: Fifty-two patients were listed, of whom 14 had mechanical circulatory support (MCS). Thirty-six patients underwent transplantation and 27 patients survived ≥1 year post-HTx (74%, as compared with 88% average 1-year survival in HTx patients without suspected liver disease; p < 0.01). Survivors had a lower liver risk score at evaluation for HTx (31.0 ± 20.4 vs 65.2 ± 28.6, p < 0.01). A cut-point of 45 for liver risk score was identified by receiver-operating-characteristic (ROC) analysis. In the analysis using Cox proportional hazards models, a liver risk score ≥45 at evaluation for HTx was associated with greater risk of death at 1 year post-HTx compared with a score of <45 in both univariable (HR 3.94, 95% CI 1.77-8.79, p < 0.001) and multivariable (HR 4.35, 95% CI 1.77-8.79, p < 0.001) analyses. Patients who died <1 year post-HTx had an increased frequency of acute graft dysfunction (44.4% vs 3.7%, p = 0.009), longer ventilation times (55.6% vs 11.1%, p = 0.013) and severe bleeding events (44.4% vs 11.1%, p = 0.049). The liver risk score at evaluation for HTx also predicted 1-year mortality after HTx listing (p < 0.001). CONCLUSIONS: Patients with HF and advanced liver dysfunction are high-risk HTx candidates. Liver biopsy in addition to MELD-XI improves risk stratification of patients with advanced HF and suspected irreversible liver dysfunction.