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

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™

Study Overview

• Status: Active, not recruiting
• Conditions: Sepsis; Acute Kidney Injury
• Intervention / Treatment: Device: 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 Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• Brazil
  • Rio De Janeiro, Brazil, 22281-100
    • Nefro Consultoria de Doenças Renais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• COVID19 diagnosis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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 Oxiris™	Device: Adsorption membrane filter Oxiris™; Continuous Renal Replacement Therapy with the adsorption membrane filter Oxiris™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Nefro Consultoria de Doenças Renais Ltda
• Collaborators: Baxter Healthcare Corporation
• Investigators: Principal Investigator: Elisabeth R Maccariello, MD, PhD, Nefro Consultoria de Doenças Renais

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: December 10, 2023
• First Submitted That Met QC Criteria: February 9, 2024
• First Posted (Actual): February 12, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 9, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Sepsis; Cytokines; Acute Kidney Injury; Blood Purification; Adsorptive membranes
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Kidney Diseases; Urologic Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Renal Insufficiency; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sepsis; Toxemia; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: Nefro01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes