ABSTRACT
Background & Aims: Effective treatments for acute-on-chronic liver failure (ACLF) are a major unmet need. This proof-of-concept pilot study was aimed at evaluating the effects of plasma exchange (PE) with albumin 5% (PE-A5%) on albumin functional capacity and organ dysfunction in patients with ACLF. Methods: Ten adult patients were enrolled in a single-center phase II, prospective, open-label, non-controlled study. Six PE-A5% sessions were performed in 10 days followed by a 1-month follow-up visit. Albumin functional capacity and circulatory function were assessed, as were renal, cerebral, and liver function, and systemic inflammation. The main safety variable was the percentage of PE sessions associated with at least one procedure-related adverse event (AE). Results: Patients with ACLF showed lower albumin binding capacity, lower antioxidant capacity, and lower levels of albumin with preserved structure compared to healthy donors (n = 19). From baseline to day 11, PE-A5% treatment increased albumin levels and improved albumin binding capacity to Sudlow site II (15.3±1.6 mg/ml to 18.9±1.7 mg/ml; p = 0.003), fatty acid-binding capacity (8.2±1.4 µM to 3.1±1.5 µM; p = 0.013) and antioxidant capacity (human mercaptalbumin 9.5±1.5 mg/ml to 14.6±1.6 mg/ml; p = 0.001). Native albumin levels were increased throughout day 1-11 PE-A5% sessions (6.5±1.0 mg/ml to 10.2±1.4 mg/ml; p = 0.035). PE-A5% improved systemic hemodynamics (mean arterial pressure, heart rate, cardiac index), renal function (creatinine level, blood urea nitrogen), cerebral function (hepatic encephalopathy grade), liver parameters (transaminases, bilirubin) and inflammatory parameters (C-reactive protein, leukocyte count). All patients had at least one of the 78 AEs reported, mostly mild (product/procedure-related: 36%). Sixteen serious AEs were reported in eight patients (procedure/product-related: none). Conclusions: PE-A5% was a safe procedure associated with positive effects on albumin functionality, and circulatory, renal, cerebral, and liver function in patients with ACLF. Impact and implications: Acute-on-chronic liver failure (ACLF) is a clinical condition characterized by severe systemic inflammation, organ failure, and high mortality. Plasma exchange removes patient's plasma containing pathogenic substances, replacing it with 5% albumin and fresh frozen plasma (PE-A5%). In this study, cirrhotic patients with ACLF were treated with PE-A5%, which was a safe procedure that increased binding and antioxidant capacity of patients' albumin, while improving circulatory, kidney, brain, and liver functions. These beneficial effects could impact survival in ACLF. ClinicalTrialsgov Identifier: NCT01201720. EudraCT number: 2010-021360-15.
ABSTRACT
The present research aims to present and describe an unusual and rare anatomical variation in relation to the drainage of the right gonadal vein. This anatomical knowledge is crucial as it assists in the work of surgeons and health professionals in general. The dissection occurred in the anterior wall of the abdomen and, through observational analysis, an anatomical variation was found in the drainage of the right gonadal vein in a human cadaver, obtained by anonymous donation, male gender and without predetermined clinical characteristics, ethnicity, and age, belonging to the Padre Albino University Center collection. This research was approved by the Research Ethics Committee under protocol 12923919.8.0000.5430. The drainage of right gonadal vein is this variant occurs anastomosed with an innominate venous trunk that empties into the inferior vena cava. Furthermore, the presence of an accessory right renal vein is also noticed, which anastomoses with the innominate venous trunk and with the right renal vein, through a vein suggestively called interrenal, differing from the anatomical normality described in the literature. This variation is supposed to occur due to flaws in the development of the embryo, which generate venous changes in the origins of the right gonadal vein. Acknowledging the existence of it is relevant when performing surgical procedures in the region, as it differs from the most frequent anatomy found in the human population. The rare drainage of the right gonadal vein through an innominate trunk to the inferior vena cava and its importance is highlighted in this article.
