Timing of Renal Replacement Therapy Initiation in Tumor Lysis Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Patient or family opposition to data collection for research purposes.
Incomplete medical records that preclude data extraction.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
800 Participants
are grouped into 2 trial groupsGroup A: Patients with early initiation of renal replacement therapy (RRT)
Group B: Patients with delayed initiation of RRT
Trial outcomes
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.
Time frame
From baseline to up to 30 days .Secondary outcomes
1
Incidence of AKI
Incidence of AKI related to Tumor lysis syndrome (TLS), assessed at ICU admission.
Time frame
At baseline2
Use of RRT for TLS-related AKI
Use of RRT for TLS-related AKI, assessed during ICU stay.
Time frame
From baseline to up to 30 days.3
Renal recovery
90-day renal recovery, assessed at 90 days post-admission.
Time frame
At 90 days after baseline4
Long-term renal function
Long-term renal function is assessed by creatinine at one year
Time frame
12 months after baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov