Volume Removal Intolerance During Net Ultrafiltration in Acute Kidney Injury Patients
NCT07643597
Acute Kidney Injury, Critical Illness
Salvador, Brazil
View Trial DetailsNCT Number: NCT06889974
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
CHU d'Angers, Angers, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At baseline
Incidence of AKI related to Tumor lysis syndrome (TLS), assessed at ICU admission.
Time frame: From baseline to up to 30 days.
Use of RRT for TLS-related AKI, assessed during ICU stay.
Time frame: At 90 days after baseline
90-day renal recovery, assessed at 90 days post-admission.
Time frame: 12 months after baseline
Long-term renal function is assessed by creatinine at one year
Time frame: 30 days after baseline
Mortality rate at 30 days.
Time frame: 12 months after baseline
Mortality rate 12 months post ICU admission
Time frame: 12 months after baseline
Long-term renal function is assessed by glomerular filtration rate at one year
Contact information is provided by the study sponsor or research team.
University Hospital, Bordeaux
Other
Acronym: TENDERS
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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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