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Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome (TENDERS)

U

University Hospital of Bordeaux

Status

Enrolling

Conditions

Renal Replacement Therapy for Acute Kidney Injury in ICU

Study type

Observational

Funder types

Other

Identifiers

NCT06889974
CHUBX 2024/104

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

800 participants in 2 patient groups

Patients with early initiation of renal replacement therapy (RRT)
Description:
Patients with early initiation of RRT, RRT within 24 hours of acute kidney injury (AKI) diagnosis.
Patients with delayed initiation of RRT
Description:
Patients with delayed initiation of RRT, RRT initiated only after urgent clinical indications arise, such as severe hyperkalemia or metabolic acidosis.

Trial contacts and locations

10

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Central trial contact

Arthur ORIEUX

Data sourced from clinicaltrials.gov

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