Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 10
- 主要终点
- Renal dysfunction at ICU discharge
研究概览
简要总结
The TENDERS study aims to evaluate the impact of the timing of renal replacement therapy (RRT) initiation on outcomes in patients with tumor lysis syndrome (TLS) and associated acute kidney injury (AKI). The study will compare early versus delayed RRT initiation, examining the effect on renal function at 30 days post-treatment.
详细描述
Tumor lysis syndrome (TLS) is a common and life-threatening complication in patients with hematologic malignancies, characterized by severe metabolic imbalances due to rapid tumor cell destruction. This syndrome frequently leads to acute kidney injury (AKI), requiring renal replacement therapy (RRT) in about 50% of cases. Despite its clinical significance, there is a lack of consensus on the optimal timing of RRT initiation in TLS-related AKI. Studies in other forms of AKI suggest no difference in outcomes between early and delayed RRT initiation, but these results are not directly applicable to TLS patients. This study seeks to fill this gap by analyzing the timing and outcomes of RRT initiation in TLS patients. The retrospective study will collect data from multiple intensive care units (ICUs) across France. Procedure: The study will retrospectively analyze patient data from 2013 to 2023, comparing early vs. delayed RRT initiation. Follow-up: Data on renal function, RRT usage, and mortality will be collected 30 days and one year after ICU admission.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥18 years.
- •Hospitalized in the ICU between January 1, 2013, and December 31,
- •Diagnosed with a hematologic malignancy or solid tumor requiring chemotherapy.
- •Diagnosed with TLS based on the presence of two or more biochemical criteria (e.g., hyperkalemia, hyperphosphatemia, hyperuricemia, hypocalcemia) within 3 days before or 7 days after chemotherapy initiation.
排除标准
- •Patient or family opposition to data collection for research purposes.
- •Incomplete medical records that preclude data extraction.
研究组 & 干预措施
Patients with early initiation of renal replacement therapy (RRT)
Patients with early initiation of RRT, RRT within 24 hours of acute kidney injury (AKI) diagnosis.
Patients with delayed initiation of RRT
Patients with delayed initiation of RRT, RRT initiated only after urgent clinical indications arise, such as severe hyperkalemia or metabolic acidosis.
结局指标
主要结局
Renal dysfunction at ICU discharge
时间窗: From baseline to up to 30 days .
The primary outcome is renal dysfunction at ICU discharge, defined as a ≥25% increase in serum creatinine from baseline, assessed at the time of ICU discharge.
次要结局
- Incidence of AKI(At baseline)
- Use of RRT for TLS-related AKI(From baseline to up to 30 days.)
- Renal recovery(At 90 days after baseline)
- Mortality at 30 days(30 days after baseline)
- Mortality at 12 months(12 months after baseline)
- Long-term renal function(12 months after baseline)