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Continuous Renal Replacement Therapy With Oxiris in Acute Kidney Injury and Sepsis

Exploring Clinical Management and Outcomes of Continuous Renal Replacement Therapy With Oxiris in Acute Kidney Injury and Sepsis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06253377
Enrollment
50
Registered
2024-02-12
Start date
2023-12-08
Completion date
2025-04-30
Last updated
2024-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Kidney Injury, Sepsis

Keywords

Acute Kidney Injury, Blood Purification, Adsorptive membranes, Sepsis, Cytokines

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.

Interventions

DEVICEAdsorption membrane filter Oxiris™

Continuous Renal Replacement Therapy with the adsorption membrane filter Oxiris™

Sponsors

Baxter Healthcare Corporation
CollaboratorINDUSTRY
Nefro Consultoria de Doenças Renais Ltda
Lead SponsorNETWORK

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* COVID19 diagnosis

Design outcomes

Primary

MeasureTime frameDescription
Mortality observed and estimated by predictive indexesThrough study completion, an average of 5 yearsIn-hospital mortality observed and estimated by the predictive index (SAPS III) during the hospitalization which developed AKI and need CRRT with Oxiris

Secondary

MeasureTime frameDescription
Management of hemodynamic drugs during CRRTThrough study completion, an average of 5 yearsDaily dosage of hemodynamic active drugs (mg/day) during the hospitalization which developed AKI and need CRRT with Oxiris
Hemorrhagic complications during CRRTThrough study completion, an average of 5 yearsOccurrence of hemorrhagic events during the hospitalization which developed AKI and need CRRT with Oxiris
CRRT circuit life-timeThrough study completion, an average of 5 yearsDays of CRRT circuit with Oxiris utilization, during the hospitalization which developed AKI and need CRRT with Oxiris
CRRT dependenceThrough study completion, an average of 5 yearsTime in days on CRRT need, during the hospitalization which developed AKI and need CRRT with Oxiris
Initial renal function recoveryThrough study completion, an average of 5 yearsTime in days to urinary debt \>1L/day, during the hospitalization which developed AKI and need CRRT with Oxiris
Length of hospital stayThrough study completion, an average of 5 yearsLength of hospital stay in days of hospitalization which developed AKI and need CRRT with Oxiris
Renal function recovery in medium termAt 30 days after hospital admission in which participants developed AKIRenal function by creatinine levels (mg/dl) at 30 days after hospital admission of the hospitalization which developed AKI and need CRRT with Oxiris
Renal function recovery at dischargeThrough study completion, an average of 5 yearsRenal function by creatinine levels (mg/dl) at discharge of the hospitalization which developed AKI and need CRRT with Oxiris
Dialysis dependence in long termThrough study completion, an average of 5 yearsDialysis dependence at discharge of the hospitalization which developed AKI and need CRRT with Oxiris

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026