Trial · NCT07497438
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Increase of at least 1 point in the modified SOFA score (excluding the hematologic component) for at least two organ systems compared to Day 0. In the delayed arm, the use of rescue etoposide treatment or in case of secondary aggravation during follow-up | every 12 hours from Day 1 to Day 5 (Day 0 = inclusion), and then every 24 hours from Day 6 to Day 14 | The occurrence of an event defined as the onset or worsening of organ failures, evaluated using the modified Sequential Organ Failure Assessment (SOFA) score (excluding the hematologic component, from 0 to 20 points), calculated every 12 hours from Day 1 to Day 5 (Day 0 = inclusion), and then every 24 hours from Day 6 to Day 14. An event will be defined as an increase of at least 1 point for at least two organ systems compared to Day 0. In the delayed arm, the use of rescue etoposide treatment or in case of secondary aggravation during follow-up will also be considered an event. |
| Secondary | Survival | 60 days | Time to death after inclusion (with a maximum follow-up duration of 60 days) |
| Secondary | Duration of mechanical ventilation | 14 days after inclusion | Number of ventilator-free days between inclusion and Day 14. A live discharge from the intensive care unit will be considered equivalent to no mechanical ventilation (event) from the date of discharge. Patients who died before day 14 will be assigned a value of 0 days, corresponding to no days alive without ventilation. |
| Secondary | Duration of catecholamine therapy | 14 days after inclusion | Number of catecholamine-free days between inclusion and Day 14. A live discharge from the intensive care unit will be considered equivalent to an absence of catecholamines (event) from the date of discharge. Patients who died before D14 will be assigned a value of 0 days, corresponding to an absence of live days without catecholamines. |
| Secondary | Need for renal replacement therapy. | 14 days after inclusion | Proportion of patients receiving at least one session of renal replacement therapy between inclusion and Day 14. Discharge from intensive care without prior extrarenal purification will be considered a non-event. Death without prior extrarenal purification will be considered a non-event. |
| Secondary | Length of stay in the intensive care unit | 60 days | Length of stay in the intensive care unit |
| Secondary | Length of hospital stay | 60 days | Length of hospital stay |
| Secondary | Proportion of patients receiving etoposide treatment | 60 days | Proportion of patients receiving a dose of etoposide |
| Secondary | Cumulative dose of etoposide | 14 days after inclusion | Cumulative dose of etoposide over the first 14 days, within the total study population and among those receiving at least one dose of treatment |
| Secondary | Time to initiation of etoposide treatment | 60 days | Number of days between inclusion and initiation of etoposide treatment in patients who received etoposide. |
| Secondary | Number of patients receiving another immunosuppressive treatment | 60 days | Number of patients receiving another immunosuppressive treatment during the intensive care unit stay up to Day 14. Treatment received outside the intensive care unit will not be taken into account. |
| Secondary | Normalization of HLH-related biological abnormalities | 14 days after inclusion | Time from inclusion to normalization of fibrinogen (\> 2 g/L), decrease in ferritin (\< 2000 µg/L), and decrease in triglycerides (\< 1.5 mg/dL) during the intensive care unit stay up to Day 14. These blood tests will be performed daily as part of routine care during the period of intensive care. |
| Secondary | Evolution of the HScore (probability score for HLH) | 2, 7, and 14 days after inclusion | HScore at Days 2, 7, and 14. In the event of missing data (particularly for hemophagocytosis), the latest available data will be used |
| Secondary | Potential side effects attributable to etoposide, such as healthcare-associated infections, incidence of neutropenia, and bleeding events | 60 days | Proportion of patients with at least one healthcare-associated infection, neutropenia acquired after inclusion and its duration, if applicable (defined by PNN \<500/mm³), a bleeding event after inclusion requiring transfusion and/or surgery. Patients with neutropenia on admission will be excluded from the neutropenia analysis. Complete blood counts, bleeding events, and transfusions will be monitored daily. |
| Secondary | Evolution of the SOFA score and modified SOFA score. | 14 days after inclusion | Delta SOFA at Days 2 and 5, maximum SOFA score, including both SOFA and modified SOFA. The SOFA score will be calculated daily, in accordance with the protocol for the primary endpoint. The maximum SOFA score during the first 14 days will be used. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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