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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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 . |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur ORIEUX | Contact | 05 56 70 56 79 | +33 | arthur.orieux@chu-bordeaux.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Withdrawn | Angers | France | |||
| Hôpital Pellegrin |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| 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 |
| Recruiting |
| Bordeaux |
| France |
|
| Hôpital la cavale blanche | Recruiting | Brest | France |
|
| CHU Dupuytren 1 | Withdrawn | Limoges | France |
| Hôtel-Dieu | Recruiting | Nantes | France |
|
| CHR d'Orléans | Recruiting | Orléans | France |
|
| CH de Pau | Recruiting | Pau | France |
|
| Centre Urgences-Réanimations | Recruiting | Rennes | France |
|
| IUCT-O Hopital Purpan | Recruiting | Toulouse | France |
|
| Hôpital Bretonneau | Recruiting | Tours | France |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |