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Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome

Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06889974
Acronym
TENDERS
Enrollment
800
Registered
2025-03-21
Start date
2025-07-01
Completion date
2027-07-31
Last updated
2026-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Replacement Therapy for Acute Kidney Injury in ICU

Keywords

tumoral lysis syndrome, acute kidney injury, renal replacement therapy, timing

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.

Interventions

None listed

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Renal dysfunction at ICU dischargeFrom 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

MeasureTime frameDescription
Incidence of AKIAt baselineIncidence of AKI related to Tumor lysis syndrome (TLS), assessed at ICU admission.
Use of RRT for TLS-related AKIFrom baseline to up to 30 days.Use of RRT for TLS-related AKI, assessed during ICU stay.
Mortality at 12 months12 months after baselineMortality rate 12 months post ICU admission
Long-term renal function12 months after baselineLong-term renal function is assessed by creatinine at one year
Mortality at 30 days30 days after baselineMortality rate at 30 days.
Renal recoveryAt 90 days after baseline90-day renal recovery, assessed at 90 days post-admission.

Countries

France

Contacts

Primary ContactArthur ORIEUX
arthur.orieux@chu-bordeaux.fr05 56 70 56 79

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026