Clinical trial NCT06889974: Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome
Official title: Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Renal Replacement Therapy for Acute Kidney Injury in ICU
Keywords: tumoral lysis syndrome
acute kidney injury
renal replacement therapy, timing
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective, multicenter cohort study conducted across several intensive care units (ICUs) in France. Data will be collected retrospectively from patient records and analyzed to assess the impact of early versus delayed RRT initiation on clinical outcomes in patients with TLS-induced AKI.

Brief summary: 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.

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.

Primary outcomes:
measure: Renal dysfunction at ICU discharge
timeFrame: From baseline to up to 30 days .
Secondary outcomes:
measure: Incidence of AKI
timeFrame: At baseline
measure: Use of RRT for TLS-related AKI
timeFrame: From baseline to up to 30 days.
measure: Renal recovery
timeFrame: At 90 days after baseline
measure: Long-term renal function
timeFrame: 12 months after baseline
measure: Mortality at 30 days
timeFrame: 30 days after baseline
measure: Mortality at 12 months
timeFrame: 12 months after baseline
measure: Long-term renal function
timeFrame: 12 months after baseline
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: Hôpital Pellegrin
city: Brest
country: France
facility: Hôpital la cavale blanche
city: Limoges
country: France
facility: CHU Dupuytren 1
city: Nantes
country: France
facility: Hôtel-Dieu
city: Orléans
country: France
facility: CHR d'Orléans
city: Pau
country: France
facility: CH de Pau
city: Rennes
country: France
facility: Centre Urgences-Réanimations
city: Tours
country: France
facility: Hôpital Bretonneau
Study officials:
References: