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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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It is an epidemiology study to explore outcomes in patients with acute kidney injury (AKI) and sepsis submitted to continuous renal replacement therapy (CRRT) with Oxirisâ„¢.
Objectives:
Describe the experience and outcomes in patients with sepsis and AKI treated receiving CRRT with the adsorption membrane filter Oxirisâ„¢
Study Background & Rationale:
Acute kidney injury (AKI) is common in patients with sepsis, occurring in 5-50%. It happens in the context of a critical illness requiring intensive care. Fifteen percent require renal replacement therapy as supportive therapy until the kidneys recover. Membrane-coated filters, such as Oxirisâ„¢, promote high filtration clearance of uremic toxins, but additionally removal of inflammatory mediators and bacterial liposaccharide (LPS) . Even though this potential mechanism should be expected to benefit septic and AKI patients, results have not been uniform.
The investigators´ group has been prescribing CRRT for AKI treatment for the last 20 years, having performed more than 20 thousand procedures. The investigators´ group experience with Oxiris™ filter in CRRT started in 2018. The objective of the study is to describe the clinical operational management of CRRT with this kind of filter and to explore patients' outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study cohort | Patients with Acute Kidney Injury and Renal Replacement Therapy indication, following local clinical patterns, who were treated with Continuous Renal Replacement Therapy with the adsorption membrane filter Oxirisâ„¢ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adsorption membrane filter Oxirisâ„¢ | Device | Continuous Renal Replacement Therapy with the adsorption membrane filter Oxirisâ„¢ |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality observed and estimated by predictive indexes | In-hospital mortality observed and estimated by the predictive index (SAPS III) during the hospitalization which developed AKI and need CRRT with Oxiris | Through study completion, an average of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Management of hemodynamic drugs during CRRT | Daily dosage of hemodynamic active drugs (mg/day) during the hospitalization which developed AKI and need CRRT with Oxiris | Through study completion, an average of 5 years |
| Hemorrhagic complications during CRRT |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with sepsis and acute kidney injury treated receiving continuous renal replacement therapy with the adsorption membrane filter Oxiris
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth R Maccariello, MD, PhD | Nefro Consultoria de Doenças Renais | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nefro Consultoria de Doenças Renais | Rio de Janeiro | 22281-100 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30135570 | Result | Hoste EAJ, Kellum JA, Selby NM, Zarbock A, Palevsky PM, Bagshaw SM, Goldstein SL, Cerda J, Chawla LS. Global epidemiology and outcomes of acute kidney injury. Nat Rev Nephrol. 2018 Oct;14(10):607-625. doi: 10.1038/s41581-018-0052-0. | |
| 29728790 | Result | Malard B, Lambert C, Kellum JA. In vitro comparison of the adsorption of inflammatory mediators by blood purification devices. Intensive Care Med Exp. 2018 May 4;6(1):12. doi: 10.1186/s40635-018-0177-2. |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Occurrence of hemorrhagic events during the hospitalization which developed AKI and need CRRT with Oxiris |
| Through study completion, an average of 5 years |
| CRRT circuit life-time | Days of CRRT circuit with Oxiris utilization, during the hospitalization which developed AKI and need CRRT with Oxiris | Through study completion, an average of 5 years |
| CRRT dependence | Time in days on CRRT need, during the hospitalization which developed AKI and need CRRT with Oxiris | Through study completion, an average of 5 years |
| Initial renal function recovery | Time in days to urinary debt >1L/day, during the hospitalization which developed AKI and need CRRT with Oxiris | Through study completion, an average of 5 years |
| Length of hospital stay | Length of hospital stay in days of hospitalization which developed AKI and need CRRT with Oxiris | Through study completion, an average of 5 years |
| Renal function recovery in medium term | Renal function by creatinine levels (mg/dl) at 30 days after hospital admission of the hospitalization which developed AKI and need CRRT with Oxiris | At 30 days after hospital admission in which participants developed AKI |
| Renal function recovery at discharge | Renal function by creatinine levels (mg/dl) at discharge of the hospitalization which developed AKI and need CRRT with Oxiris | Through study completion, an average of 5 years |
| Dialysis dependence in long term | Dialysis dependence at discharge of the hospitalization which developed AKI and need CRRT with Oxiris | Through study completion, an average of 5 years |
| 31443997 | Result | Peerapornratana S, Manrique-Caballero CL, Gomez H, Kellum JA. Acute kidney injury from sepsis: current concepts, epidemiology, pathophysiology, prevention and treatment. Kidney Int. 2019 Nov;96(5):1083-1099. doi: 10.1016/j.kint.2019.05.026. Epub 2019 Jun 7. |
| 17310365 | Result | Maccariello E, Soares M, Valente C, Nogueira L, Valenca RV, Machado JE, Rocha E. RIFLE classification in patients with acute kidney injury in need of renal replacement therapy. Intensive Care Med. 2007 Apr;33(4):597-605. doi: 10.1007/s00134-007-0535-0. Epub 2007 Feb 20. |
| 19812539 | Result | Maccariello E, Valente C, Nogueira L, Bonomo H, Ismael M, Machado JE, Baldotto F, Godinho M, Valenca R, Rocha E, Soares M. SAPS 3 scores at the start of renal replacement therapy predict mortality in critically ill patients with acute kidney injury. Kidney Int. 2010 Jan;77(1):51-6. doi: 10.1038/ki.2009.385. |
| 26195505 | Result | Bouchard J, Acharya A, Cerda J, Maccariello ER, Madarasu RC, Tolwani AJ, Liang X, Fu P, Liu ZH, Mehta RL. A Prospective International Multicenter Study of AKI in the Intensive Care Unit. Clin J Am Soc Nephrol. 2015 Aug 7;10(8):1324-31. doi: 10.2215/CJN.04360514. Epub 2015 Jul 20. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |