Program for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA
Biostatistics and Data Management Core, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
BMJ Open. 2023 Jul 7;13(7):e075960. doi: 10.1136/bmjopen-2023-075960.
Observational studies have linked slower and faster net ultrafiltration (UF) rates during kidney replacement therapy (KRT) with mortality in critically ill patients with acute kidney injury (AKI) and fluid overload. To inform the design of a larger randomised trial of patient-centered outcomes, we conduct a feasibility study to examine restrictive and liberal approaches to UF during continuous KRT (CKRT).
This study is an investigator-initiated, unblinded, 2-arm, comparative-effectiveness, stepped-wedged, cluster randomised trial among 112 critically ill patients with AKI treated with CKRT in 10 intensive care units (ICUs) across 2 hospital systems. In the first 6 months, all ICUs started with a liberal UF rate strategy. Thereafter, one ICU is randomised to the restrictive UF rate strategy every 2 months. In the liberal group, the UF rate is maintained between 2.0 and 5.0 mL/kg/hour; in the restrictive group, the UF rate is maintained between 0.5 and 1.5 mL/kg/hour. The three coprimary feasibility outcomes are (1) between-group separation in mean delivered UF rates; (2) protocol adherence; and (3) patient recruitment rate. Secondary outcomes include daily and cumulative fluid balance, KRT and mechanical ventilation duration, organ failure-free days, ICU and hospital length of stay, hospital mortality and KRT dependence at hospital discharge. Safety endpoints include haemodynamics, electrolyte imbalance, CKRT circuit issues, organ dysfunction related to fluid overload, secondary infections and thrombotic and haematological complications.
The University of Pittsburgh Human Research Protection Office approved the study, and an independent Data and Safety Monitoring Board monitors the study. A grant from the United States National Institute of Diabetes and Digestive and Kidney Diseases sponsors the study. The trial results will be submitted for publication in peer-reviewed journals and presented at scientific conferences.
This trial has been prospectively registered with clinicaltrials.gov (NCT05306964). Protocol version identifier and date: 1.5; 13 June 2023.
观察性研究表明，在接受肾脏替代治疗（KRT）的重症急性肾损伤（AKI）合并液体超负荷患者中，较慢和较快的净超滤（UF）速率与死亡率相关。为了为一项更大规模的以患者为中心的结局的随机试验提供信息，我们进行了一项可行性研究，以检查连续 KRT（CKRT）期间 UF 的限制和宽松方法。
这项研究是一项由研究者发起的、非盲的、2 臂、比较有效性、阶梯楔形、集群随机试验，纳入了在 2 个医院系统的 10 个重症监护病房（ICU）接受 CKRT 治疗的 112 名 AKI 重症患者。在前 6 个月，所有 ICU 均采用宽松 UF 率策略开始。此后，每 2 个月随机选择一个 ICU 采用限制 UF 率策略。在宽松组中，UF 率维持在 2.0 至 5.0 mL/kg/h；在限制组中，UF 率维持在 0.5 至 1.5 mL/kg/h。三个主要可行性结果是（1）组间平均给予 UF 率的分离；（2）方案依从性；和（3）患者招募率。次要结果包括每日和累积液体平衡、KRT 和机械通气持续时间、无器官衰竭天数、ICU 和住院时间、医院死亡率以及出院时对 KRT 的依赖。安全性终点包括血流动力学、电解质失衡、CKRT 回路问题、与液体超负荷相关的器官功能障碍、继发感染以及血栓和血液学并发症。
匹兹堡大学人类研究保护办公室批准了该研究，一个独立的数据和安全监测委员会监测该研究。美国国立糖尿病、消化和肾脏疾病研究所的一项拨款资助了该研究。试验结果将提交给同行评议期刊发表，并在科学会议上报告。
这项试验已在临床试验.gov（NCT05306964）前瞻性注册。方案版本标识符和日期：1.5；2023 年 6 月 13 日。
