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

Active, not recruiting

• Conditions: Acute Kidney Injury; Sepsis
• Interventions: Device: Adsorption membrane filter Oxiris™

• Registration Number: NCT06253377
• Lead Sponsor: Nefro Consultoria de Doenças Renais Ltda

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.

Study Timeline

• Status Verified: 2023-12
• Study Start: 2023-12-08
• Study First Submitted: 2023-12-10
• Study First Submitted QC: 2024-02-09
• Last Update Submitted: 2024-02-09
• Study First Posted: 2024-02-12
• Last Update Posted: 2024-02-12
• Primary Completion: 2024-10
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• COVID19 diagnosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study cohort	Adsorption membrane filter Oxiris™	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 Oxiris™

Primary Outcome Measures

Name	Time	Method
Mortality observed and estimated by predictive indexes	Through study completion, an average of 5 years	In-hospital mortality observed and estimated by the predictive index (SAPS III) during the hospitalization which developed AKI and need CRRT with Oxiris

Secondary Outcome Measures

Name	Time	Method
Renal function recovery at discharge	Through study completion, an average of 5 years	Renal function by creatinine levels (mg/dl) at discharge of the hospitalization which developed AKI and need CRRT with Oxiris
Management of hemodynamic drugs during CRRT	Through study completion, an average of 5 years	Daily dosage of hemodynamic active drugs (mg/day) during the hospitalization which developed AKI and need CRRT with Oxiris
CRRT circuit life-time	Through study completion, an average of 5 years	Days of CRRT circuit with Oxiris utilization, during the hospitalization which developed AKI and need CRRT with Oxiris
CRRT dependence	Through study completion, an average of 5 years	Time in days on CRRT need, during the hospitalization which developed AKI and need CRRT with Oxiris
Length of hospital stay	Through study completion, an average of 5 years	Length of hospital stay in days of hospitalization which developed AKI and need CRRT with Oxiris
Hemorrhagic complications during CRRT	Through study completion, an average of 5 years	Occurrence of hemorrhagic events during the hospitalization which developed AKI and need CRRT with Oxiris
Renal function recovery in medium term	At 30 days after hospital admission in which participants developed AKI	Renal function by creatinine levels (mg/dl) at 30 days after hospital admission of the hospitalization which developed AKI and need CRRT with Oxiris
Initial renal function recovery	Through study completion, an average of 5 years	Time in days to urinary debt \>1L/day, during the hospitalization which developed AKI and need CRRT with Oxiris
Dialysis dependence in long term	Through study completion, an average of 5 years	Dialysis dependence at discharge of the hospitalization which developed AKI and need CRRT with Oxiris

Trial Locations

Locations (1)

Nefro Consultoria de Doenças Renais; 🇧🇷 Rio De Janeiro, Brazil