Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome

NCT06889974 | Recruiting

• 1 other identifier: CHUBX 2024/104
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 10

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.

Conditions

Renal Replacement Therapy for Acute Kidney Injury in ICU

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Renal dysfunction at ICU discharge

  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.

  From baseline to up to 30 days .

Secondary Outcomes (7)

• Incidence of AKI

  At baseline

• Use of RRT for TLS-related AKI

  From baseline to up to 30 days.

• Renal recovery

  At 90 days after baseline

• Long-term renal function

  12 months after baseline

• Mortality at 30 days

  30 days after baseline

Study Arms (2)

Patients with early initiation of renal replacement therapy (RRT)

Patients with early initiation of RRT, RRT within 24 hours of acute kidney injury (AKI) diagnosis.

Patients with delayed initiation of RRT

Patients with delayed initiation of RRT, RRT initiated only after urgent clinical indications arise, such as severe hyperkalemia or metabolic acidosis.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patient or family opposition to data collection for research purposes.
• Incomplete medical records that preclude data extraction.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (10)

CHU d'Angers

Angers, France

WITHDRAWN

Hôpital Pellegrin

Bordeaux, France

RECRUITING

Hôpital la cavale blanche

Brest, France

RECRUITING

CHU Dupuytren 1

Limoges, France

WITHDRAWN

Hôtel-Dieu

Nantes, France

RECRUITING

CHR d'Orléans

Orléans, France

RECRUITING

CH de Pau

Pau, France

RECRUITING

Centre Urgences-Réanimations

Rennes, France

RECRUITING

IUCT-O Hopital Purpan

Toulouse, France

RECRUITING

Hôpital Bretonneau

Tours, France

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Arthur ORIEUX

CONTACT

05 56 70 56 79; arthur.orieux@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 21, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)