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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06253377
• Other study ID #: Nefro01
• Status: Active, not recruiting
• Start date: December 8, 2023
• Est. completion date: April 2025

Study information

• Verified date: December 2023
• Source: Nefro Consultoria de Doenças Renais Ltda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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™

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: April 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Adults (>18 years)

• Diagnosis of AKI (KDIGO stage 3)

• Diagnosis of sepsis of any cause

Exclusion Criteria:

• COVID19 diagnosis

Related Conditions & MeSH terms

• Acute Kidney Injury
• Sepsis
• Toxemia
• Wounds and Injuries

Intervention

Device:
• Adsorption membrane filter Oxiris™
Continuous Renal Replacement Therapy with the adsorption membrane filter Oxiris™

Locations

Country	Name	City	State
Brazil	Nefro Consultoria de Doenças Renais	Rio De Janeiro

Sponsors (2)

Lead Sponsor	Collaborator
Nefro Consultoria de Doenças Renais Ltda	Baxter Healthcare Corporation

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

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.04 — View 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. — View 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. Ep — View 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. Kidne — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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