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

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.

Study Overview

• Status: Recruiting
• Conditions: Renal Replacement Therapy for Acute Kidney Injury in ICU

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.

• Study Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Arthur ORIEUX; Phone Number: +33 05 56 70 56 79; Email: arthur.orieux@chu-bordeaux.fr

Study Locations

• France
  • Angers, France
    • Withdrawn
    • CHU d'Angers
  • Bordeaux, France
    • Recruiting
    • Hôpital Pellegrin
    • Contact: Arthur ORIEUX; Phone Number: +33 05 56 79 56 79; Email: arthur.orieux@chu-bordeaux.fr
    • Sub-Investigator: Alexandre BOYER
  • Brest, France
    • Recruiting
    • Hôpital La Cavale Blanche
    • Contact: Cécile AUBRON; Phone Number: 05 56 79 56 79; Email: cecile.aubron@chu-brest.fr
  • Limoges, France
    • Withdrawn
    • CHU Dupuytren 1
  • Nantes, France
    • Recruiting
    • Hôtel-Dieu
    • Contact: Emmanuel CANET; Phone Number: 05 56 79 56 79; Email: emmanuel.canet@chu-nantes.fr
  • Orléans, France
    • Recruiting
    • CHR d'Orléans
    • Contact: Anne BRETAGNOL; Phone Number: 05 56 79 56 79; Email: anne.bretagnol@chu-orleans.fr
  • Pau, France
    • Recruiting
    • CH de Pau
    • Contact: Simon BODOT; Phone Number: 05 56 79 56 79; Email: Simon.BODOT@ch-pau.fr
  • Rennes, France
    • Recruiting
    • Centre Urgences-Réanimations
    • Contact: Jean-Marc TADIE; Phone Number: 05 56 79 56 79; Email: jeanmarc.tadie@chu-rennes.fr
  • Toulouse, France
    • Recruiting
    • IUCT-O Hopital Purpan
    • Contact: Muriel PICARD; Email: Picard.Muriel@iuct-oncopole.fr
  • Tours, France
    • Recruiting
    • Hopital Bretonneau
    • Contact: Antoine GUILLON; Phone Number: 05 56 79 56 79; Email: antoine.guillon@univ-tours.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of AKI	Incidence of AKI related to Tumor lysis syndrome (TLS), assessed at ICU admission.	At baseline
Use of RRT for TLS-related AKI	Use of RRT for TLS-related AKI, assessed during ICU stay.	From baseline to up to 30 days.
Renal recovery	90-day renal recovery, assessed at 90 days post-admission.	At 90 days after baseline
Long-term renal function	Long-term renal function is assessed by creatinine at one year	12 months after baseline
Mortality at 30 days	Mortality rate at 30 days.	30 days after baseline
Mortality at 12 months	Mortality rate 12 months post ICU admission	12 months after baseline
Long-term renal function	Long-term renal function is assessed by glomerular filtration rate at one year	12 months after baseline

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: February 25, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): January 9, 2026
• Last Update Submitted That Met QC Criteria: January 8, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: acute kidney injury; tumoral lysis syndrome; renal replacement therapy, timing
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Renal Insufficiency; Acute Kidney Injury
• Other Study ID Numbers: CHUBX 2024/104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No