A Pilot Study of a New Approach to Manage Dysregulated Inflammation Using Continuous Venous Hyperfiltration

Abstract

Background: Hemofiltration paradigms to manage critical patients who develop a dysregulated inflammatory response (DIR) are based on evaluating kidney function as an indicator of onset, adaptation and completion. Here we present the CONVEHY protocol, a Continuous Venous Hyperfiltration approach using high doses of citrate (as an anticoagulant and substitution liquid) and a non-specific adsorption membrane (AN69-ST heparin grafted). CONVEHY uses available tools to achieve clear kidney related and non-related objectives, and it is guided by the monitoring of pathophysiological responses. Methods: In a restrospective before-after clinical pilot study, the benefits of the CONVEHY were assessed in a surgery critical care unit (CCUs) in patients with DIR. We compared the response to hemofiltration with AN69- ST heparin grafted membranes when heparin (He, n=5: earlier protocol) or citrate (Ci, n=6: CONVEHY protocol) was used, evaluating their SOFA (He 11 ± 2·35; Ci 11 ± 3·63: p=0·54) and APACHE II (He 28·60 ± 9·40; Ci 24 ± 8·46: p=0·93) scores. Findings: Hospitalization (He 35·2 ± 16·3 nights; Ci 9 ± 2·53: p=0·004), hospitalisation after release from the CCUs (He 40·25 ± 21·82; Ci 13·2 ± 4·09: p=0·063), the number of patients hospitalised >20 days (He 80%; Ci 0%: p=0·048), the days requiring mechanical ventilation (He 16 ± 5·66; Ci 4 ± 1·72: p=0·004), and the predicted mortality (55·39 ± 26·13% versus real mortality in both groups of 9·1%: p=0·004). Interpretation: Under the conditions used in this study, the CONVEHY improves the outcomes in patients who develop a serious DIR. These data highlight the value in performing further studies to confirm it. Funding Statement: The authors state: This study did not received any funding. Declaration of Interests: - The authors have not received any financing from any of the following organizations: National Institutes of Health (NIH), Wellcome Trust, Howard Hughes Medical Institute (HHMI), and all other financial support, including departmental or institutional funding. -The authors have received financing from Baxter SL. (Parque Empresarial San Fernando, Edificio Londres. Avenida De Castilla, 2. 28830 San Fernando de Henares, Madrid) for the translation of the manuscript by a professional translator. -RAFAEL GARCIA-HERNANDEZ has done a consulting work and conferences inhospitals financed by Baxter SL (Parque Empresarial San Fernando, Edificio Londres. Avenida De Castilla, 2. 28830 San Fernando de Henares, Madrid) Ethics Approval Statement: The protocol for the collection of the data was approved by the hospital’s Ethical Review Board, and 11 patients were selected for inclusion onto the study, obtaining their informed consent or that of a family member for them to participate in this study.