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

NCT06253377 | Unknown FDA Device

• 1 other identifier: Nefro01
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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™

Conditions

Acute Kidney Injury; Sepsis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Management of hemodynamic drugs during CRRT

  Through study completion, an average of 5 years

• Hemorrhagic complications during CRRT

  Through study completion, an average of 5 years

• CRRT circuit life-time

  Through study completion, an average of 5 years

• CRRT dependence

  Through study completion, an average of 5 years

• Initial renal function recovery

  Through study completion, an average of 5 years

Study Arms (1)

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™

Interventions

Adsorption membrane filter Oxiris™ DEVICE

Continuous Renal Replacement Therapy with the adsorption membrane filter Oxiris™

Study cohort

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• COVID19 diagnosis

Sponsors & Collaborators

• Nefro Consultoria de Doenças Renais Ltda: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (1)

Nefro Consultoria de Doenças Renais

Rio de Janeiro, 22281-100, Brazil

Location

Related Publications (6)

• 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.

  PMID: 30135570 RESULT

• 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.

  PMID: 29728790 RESULT

• 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.

  PMID: 31443997 RESULT

• 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.

  PMID: 17310365 RESULT

• 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.

  PMID: 19812539 RESULT

• 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.

  PMID: 26195505 RESULT

MeSH Terms

Conditions

Acute Kidney Injury; Sepsis

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elisabeth R Maccariello, MD, PhD

  Nefro Consultoria de Doenças Renais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: February 12, 2024
• Study Start: December 8, 2023
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: February 12, 2024

Record last verified: 2023-12

Locations

BR (1)