Division of Nephrology and Hypertension, Department of Medicine, Mayo Clinic, Rochester, MN, USA; Division of Pulmonary and Critical Care Medicine, Department of Medicine, Mayo Clinic, Rochester, MN, USA.
Division of Nephrology and Hypertension, Department of Medicine, Mayo Clinic, Rochester, MN, USA; Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Samut Prakan, Thailand.
J Crit Care. 2024 Oct;83:154845. doi: 10.1016/j.jcrc.2024.154845. Epub 2024 Jun 15.
Continuous kidney replacement therapy (CKRT) is commonly used to manage critically ill patients with severe acute kidney injury. While recent trials focused on the correct dosing and timing of CKRT, our understanding regarding the optimum dose of net ultrafiltration is limited to retrospective data. The Restrictive versus Liberal Rate of Extracorporeal Volume Removal Evaluation in Acute Kidney Injury (RELIEVE-AKI) trial has been conducted to assess the feasibility of a prospective randomized trial in determining the optimum net ultrafiltration rate. This paper outlines the relevant challenges and solutions in implementing this complex ICU-based trial. Several difficulties were encountered, starting with clinical issues related to conducting a trial on patients with rapidly changing hemodynamics, low patient recruitment rates, increased nursing workload, and the enormous volume of data generated by patients undergoing prolonged CKRT. Following several brainstorming sessions, several points were highlighted to be considered, including the need to streamline the intervention, add more flexibility in the trial protocols, ensure comprehensive a priori planning, particularly regarding nursing roles and their compensation, and enhance data management systems. These insights are critical for guiding future ICU-based dynamically titrated intervention trials, leading to more efficient trial management, improved data quality, and enhanced patient safety.
连续肾脏替代治疗（CKRT）常用于治疗严重急性肾损伤的重症患者。虽然最近的试验侧重于 CKRT 的正确剂量和时机，但我们对净超滤最佳剂量的理解仅限于回顾性数据。限制与自由体外容量清除率评估在急性肾损伤（RELIEVE-AKI）试验中进行，以评估前瞻性随机试验确定最佳净超滤率的可行性。本文概述了在实施这项复杂的 ICU 试验中遇到的相关挑战和解决方案。在实施这项 ICU 试验中遇到了几个困难，首先是与快速变化的血流动力学患者进行试验相关的临床问题、低患者招募率、增加的护理工作量以及接受长时间 CKRT 的患者产生的大量数据。经过几次头脑风暴会议，强调了几点需要考虑的因素，包括需要简化干预措施、在试验方案中增加更多的灵活性、确保全面的预先规划，特别是护理角色及其薪酬、以及加强数据管理系统。这些见解对于指导未来基于 ICU 的动态滴定干预试验至关重要，可实现更高效的试验管理、提高数据质量和增强患者安全性。
