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NCT Number: NCT06889974

Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Renal dysfunction at ICU discharge

    Time frame: 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.

Secondary outcomes

  1. Incidence of AKI

    Time frame: At baseline

    Incidence of AKI related to Tumor lysis syndrome (TLS), assessed at ICU admission.

  2. Use of RRT for TLS-related AKI

    Time frame: From baseline to up to 30 days.

    Use of RRT for TLS-related AKI, assessed during ICU stay.

  3. Renal recovery

    Time frame: At 90 days after baseline

    90-day renal recovery, assessed at 90 days post-admission.

  4. Long-term renal function

    Time frame: 12 months after baseline

    Long-term renal function is assessed by creatinine at one year

  5. Mortality at 30 days

    Time frame: 30 days after baseline

    Mortality rate at 30 days.

  6. Mortality at 12 months

    Time frame: 12 months after baseline

    Mortality rate 12 months post ICU admission

  7. Long-term renal function

    Time frame: 12 months after baseline

    Long-term renal function is assessed by glomerular filtration rate at one year

Study contacts

Contact information is provided by the study sponsor or research team.

Arthur ORIEUX

CONTACT

[email protected]

05 56 70 56 79 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: TENDERS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 21, 2025
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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