Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Renal Replacement Therapy for Acute Kidney Injury in ICU. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Renal dysfunction at ICU discharge [Time frame: From baseline to up to 30 days .]
Secondary outcome measures (7)
- Incidence of AKI [Time frame: At baseline]
- Use of RRT for TLS-related AKI [Time frame: From baseline to up to 30 days.]
- Renal recovery [Time frame: At 90 days after baseline]
- Long-term renal function [Time frame: 12 months after baseline]
- Mortality at 30 days [Time frame: 30 days after baseline]
- Mortality at 12 months [Time frame: 12 months after baseline]
- Long-term renal function [Time frame: 12 months after baseline]
Eligibility criteria
Inclusion criteria
- Adults aged ≥18 years.
- Hospitalized in the ICU between January 1, 2013, and December 31, 2023.
- 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.
Exclusion criteria
- Patient or family opposition to data collection for research purposes.
- Incomplete medical records that preclude data extraction.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 10 centers
- CHU d'Angers — Angers
- Hôpital Pellegrin — Bordeaux
- Hôpital la cavale blanche — Brest
- CHU Dupuytren 1 — Limoges
- Hôtel-Dieu — Nantes
- CHR d'Orléans — Orléans
- CH de Pau — Pau
- Centre Urgences-Réanimations — Rennes
- … and 2 more centers
Identifiers
NCT: NCT06889974 · CHUBX 2024/104