Clinical trial NCT06253377: Continuous Renal Replacement Therapy With Oxiris in Acute Kidney Injury and Sepsis
Official title: Exploring Clinical Management and Outcomes of Continuous Renal Replacement Therapy With Oxiris in Acute Kidney Injury and Sepsis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Kidney Injury
Sepsis
Keywords: Acute Kidney Injury
Blood Purification
Adsorptive membranes
Sepsis
Cytokines
Lead sponsor: Nefro Consultoria de Doenças Renais Ltda
Sponsor class: NETWORK
Collaborators: name: Baxter Healthcare Corporation
First posted: 2024-02-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sepsis and acute kidney injury treated receiving continuous renal replacement therapy with the adsorption membrane filter Oxiris

Brief summary: 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 Oxiris™.

Objectives:

Describe the experience and outcomes in patients with sepsis and AKI treated receiving CRRT with the adsorption membrane filter Oxiris™

Detailed description: 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 Oxiris™, 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.

Eligibility criteria: Inclusion Criteria:

* Adults (\>18 years)
* Diagnosis of AKI (KDIGO stage 3)
* Diagnosis of sepsis of any cause

Exclusion Criteria:

* COVID19 diagnosis

Primary outcomes:
measure: Mortality observed and estimated by predictive indexes
timeFrame: Through study completion, an average of 5 years
Secondary outcomes:
measure: Management of hemodynamic drugs during CRRT
timeFrame: Through study completion, an average of 5 years
measure: Hemorrhagic complications during CRRT
timeFrame: Through study completion, an average of 5 years
measure: CRRT circuit life-time
timeFrame: Through study completion, an average of 5 years
measure: CRRT dependence
timeFrame: Through study completion, an average of 5 years
measure: Initial renal function recovery
timeFrame: Through study completion, an average of 5 years
measure: Length of hospital stay
timeFrame: Through study completion, an average of 5 years
measure: Renal function recovery in medium term
timeFrame: At 30 days after hospital admission in which participants developed AKI
measure: Renal function recovery at discharge
timeFrame: Through study completion, an average of 5 years
measure: Dialysis dependence in long term
timeFrame: Through study completion, an average of 5 years
Other outcomes:
Locations:
city: Rio De Janeiro
country: Brazil
facility: Nefro Consultoria de Doenças Renais
Study officials:
affiliation: Nefro Consultoria de Doenças Renais
name: Elisabeth R Maccariello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.