Alexander Zarbock1, Mira Küllmar1, Marlies Ostermann2, Gianluca Lucchese2, Kamran Baig2, Armando Cennamo2, Ronak Rajani2, Stuart McCorkell2, Christian Arndt3, Hinnerk Wulf3, Marc Irqsusi4, Fabrizio Monaco5, Ambra Licia Di Prima5, Mercedes García Alvarez6, Stefano Italiano6, Jordi Miralles Bagan6, Gudrun Kunst7, Shrijit Nair7, Camilla L'Acqua8, Eric Hoste9, Wim Vandenberghe9, Patrick M Honore10, John A Kellum11, Lui G Forni12, Philippe Grieshaber13, Christina Massoth1, Raphael Weiss1, Joachim Gerss14, Carola Wempe1, Melanie Meersch1. 1. From the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine, University Hospital Münster, Münster, Germany. 2. Department of Critical Care, Guy's & St Thomas' National Health Service Foundation Hospital, London, United Kingdom. 3. Department of Anesthesiology and Intensive Care Medicine. 4. Department of Cardiac Surgery, University Hospital Marburg, Marburg, Germany. 5. Department of Anesthesia and Intensive Care, Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele Scientific Institute, Milan, Italy. 6. Department of Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 7. Department of Anesthetics, King's College Hospital, Denmark Hill, London, United Kingdom. 8. Department of Anesthesia and Critical Care, Centro Cardiologico Monzino Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy. 9. Department of Intensive Care Medicine, University Hospital Gent, Gent, Belgium. 10. Department of Intensive Care, CHU Brugmann University Hospital, Brussels, Belgium. 11. Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania. 12. Department of Intensive Care Medicine, Royal Surrey County Hospital & Faculty of Health Sciences, University of Surrey, Guildford, United Kingdom. 13. Department of Cardiac Surgery, University Hospital Giessen, Giessen, Germany. 14. Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.
Abstract
BACKGROUND: Prospective, single-center trials have shown that the implementation of the Kidney Disease: Improving Global Outcomes (KDIGO) recommendations in high-risk patients significantly reduced the development of acute kidney injury (AKI) after surgery. We sought to evaluate the feasibility of implementing a bundle of supportive measures based on the KDIGO guideline in high-risk patients undergoing cardiac surgery in a multicenter setting in preparation for a large definitive trial. METHODS: In this multicenter, multinational, randomized controlled trial, we examined the adherence to the KDIGO bundle consisting of optimization of volume status and hemodynamics, functional hemodynamic monitoring, avoidance of nephrotoxic drugs, and prevention of hyperglycemia in high-risk patients identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 [TIMP-2] and insulin growth factor-binding protein 7 [IGFBP7] after cardiac surgery. The primary end point was the adherence to the bundle protocol and was evaluated by the percentage of compliant patients with a 95% confidence interval (CI) according to Clopper-Pearson. Secondary end points included the development and severity of AKI. RESULTS: In total, 278 patients were included in the final analysis. In the intervention group, 65.4% of patients received the complete bundle as compared to 4.2% in the control group (absolute risk reduction [ARR] 61.2 [95% CI, 52.6-69.9]; P < .001). AKI rates were statistically not different in both groups (46.3% intervention versus 41.5% control group; ARR -4.8% [95% CI, -16.4 to 6.9]; P = .423). However, the occurrence of moderate and severe AKI was significantly lower in the intervention group as compared to the control group (14.0% vs 23.9%; ARR 10.0% [95% CI, 0.9-19.1]; P = .034). There were no significant effects on other specified secondary outcomes. CONCLUSIONS: Implementation of a KDIGO-derived treatment bundle is feasible in a multinational setting. Furthermore, moderate to severe AKI was significantly reduced in the intervention group.
RCT Entities:
BACKGROUND: Prospective, single-center trials have shown that the implementation of the Kidney Disease: Improving Global Outcomes (KDIGO) recommendations in high-risk patients significantly reduced the development of acute kidney injury (AKI) after surgery. We sought to evaluate the feasibility of implementing a bundle of supportive measures based on the KDIGO guideline in high-risk patients undergoing cardiac surgery in a multicenter setting in preparation for a large definitive trial. METHODS: In this multicenter, multinational, randomized controlled trial, we examined the adherence to the KDIGO bundle consisting of optimization of volume status and hemodynamics, functional hemodynamic monitoring, avoidance of nephrotoxic drugs, and prevention of hyperglycemia in high-risk patients identified by the urinary biomarkers tissue inhibitor of metalloproteinases-2 [TIMP-2] and insulin growth factor-binding protein 7 [IGFBP7] after cardiac surgery. The primary end point was the adherence to the bundle protocol and was evaluated by the percentage of compliant patients with a 95% confidence interval (CI) according to Clopper-Pearson. Secondary end points included the development and severity of AKI. RESULTS: In total, 278 patients were included in the final analysis. In the intervention group, 65.4% of patients received the complete bundle as compared to 4.2% in the control group (absolute risk reduction [ARR] 61.2 [95% CI, 52.6-69.9]; P < .001). AKI rates were statistically not different in both groups (46.3% intervention versus 41.5% control group; ARR -4.8% [95% CI, -16.4 to 6.9]; P = .423). However, the occurrence of moderate and severe AKI was significantly lower in the intervention group as compared to the control group (14.0% vs 23.9%; ARR 10.0% [95% CI, 0.9-19.1]; P = .034). There were no significant effects on other specified secondary outcomes. CONCLUSIONS: Implementation of a KDIGO-derived treatment bundle is feasible in a multinational setting. Furthermore, moderate to severe AKI was significantly reduced in the intervention group.
Authors: Jay L Koyner; Lakhmir S Chawla; Azra Bihorac; Kyle J Gunnerson; Rebecca Schroeder; Sevag Demirjian; Luke Hodgson; Jennifer A Frey; Scott T Wilber; J Patrick Kampf; Thomas Kwan; Paul McPherson; John A Kellum Journal: Kidney360 Date: 2022-03-24
Authors: Sevag Demirjian; C Allen Bashour; Andrew Shaw; Jesse D Schold; James Simon; David Anthony; Edward Soltesz; Crystal A Gadegbeku Journal: JAMA Date: 2022-03-08 Impact factor: 157.335
Authors: Thilo C von Groote; Marlies Ostermann; Lui G Forni; Melanie Meersch-Dini; Alexander Zarbock Journal: Intensive Care Med Date: 2021-12-18 Impact factor: 17.440