NCT04597034

Brief Summary

Abstract Title: Randomized,open-label, controlled trial to evaluate efficacy and safety of a highly selective semipermeable membrane (AN69-Oxiris) in comparison with a selective semipermeable membrane ( standard AN69) in COVID-19 associated acute kidney injury: oXAKI-COV study Rationale: Acute kidney injury (AKI) in critically ill mechanically ventilated patients with COVID-19 disease, is present in up to 30% of this group and more than 50% of them will need renal replacement therapy in the form of continuous renal replacement therapy (CRRT). Acute kidney injury in this context seems to be a marker of multiorgan dysfunction and it produces increased mortality in this population. There is a vast amount of mechanisms that lead to AKI in critically ill patients with COVID-19; however, the cytokine storm could be the strongest mechanism implicated in AKI development in individuals with continuous renal replacement therapy requirements. Therefore, blocking or reducing the cytokine storm is thought to be a therapeutic target. Highly selective semipermeable membranes (AN69-Oxiris) have been shown able to adsorb endotoxins and to eliminate inflammatory cytokines, thus representing a valuable therapeutic option in this infection. Objective: To demonstrate clinical efficacy of AN69-Oxiris membrane to reach a stable MAP, with less vasopressor dosing (at least 0.1 micrograms/kg/min) after 72h of treatment, compared to a conventional membrane (standard AN69) in critically ill patients with AKI, COVID-19 infection and requirement of continuous renal replacement therapy. Study design: Randomized,open-label, controlled trial in critically ill patients with suspected or confirmed COVID-19 disease, AKI, and criteria for continuous renal replacement therapy initiation admitted in any of the two participating institutions. Patients meeting inclusion criteria will be randomized to receive CRRT with AN69-Oxiris membrane or standard AN69 membrane during a 72h period.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at below P25 for not_applicable covid19

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 3, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2022

Completed
Last Updated

October 22, 2020

Status Verified

September 1, 2020

Enrollment Period

1.2 years

First QC Date

October 3, 2020

Last Update Submit

October 20, 2020

Conditions

Covid19AKI

Keywords

COVID-19AKICRRTAN69 OxirisAN69 Standar

Outcome Measures

Primary Outcomes (1)

  • Primary outcome:

    Change in norepinephrine requirement by at least 0.1 micrograms / kg / min to maintain similar MAP after initiation of CRRT with Oxiris membrane compared to standard AN69 membrane. MAP measurements will be performed hourly and norepinephrine requirement will be recorded at that time.

    90 days

Secondary Outcomes (3)

  • Secondary outcomes measures:

    72 hours

  • Secondary outcomes measures:

    30 days

  • Secondary outcomes measures:

    90 days

Study Arms (2)

AN69 Oxiris

EXPERIMENTAL

* To evaluate the safety in using the AN69-Oxiris membrane in contrast with the use of a conventional membrane in critically ill patients with COVID-19 associated AKI and CRRT requirements. * To examine the efficacy of the AN69-Oxiris membrane in reducing inflammatory interleukins compared with reduction using conventional membranes in this specific group of patients. * To exhibit the potential benefit of AN69-Oxiris in decreasing ICU length of stay versus the effect of using conventional membranes in COVID-19 associated AKI. * To investigate the effect of AN69-Oxiris in reducing 28-day mortality in contrast compared with the effect of a conventional membrane in this population.

Procedure: AN69-Oxiris

AN69 Standard

ACTIVE COMPARATOR

* To evaluate the safety in using the AN69-Oxiris membrane in contrast with the use of a conventional membrane in critically ill patients with COVID-19 associated AKI and CRRT requirements. * To examine the efficacy of the AN69-Oxiris membrane in reducing inflammatory interleukins compared with reduction using conventional membranes in this specific group of patients. * To exhibit the potential benefit of AN69-Oxiris in decreasing ICU length of stay versus the effect of using conventional membranes in COVID-19 associated AKI. * To investigate the effect of AN69-Oxiris in reducing 28-day mortality in contrast compared with the effect of a conventional membrane in this population.

Procedure: AN69-Standard

Interventions

AN69-OxirisPROCEDURE

To demonstrate clinical efficacy of AN69-Oxiris membrane to reach a stable MAP, with less vasopressor dosing (at least 0.1 micrograms/kg/min) after 72h of treatment, compared to a conventional membrane (standard AN69) in critically ill patients with AKI, COVID-19 infection and requirement of continuous renal replacement therapy.

AN69 Oxiris
AN69-StandardPROCEDURE

Standard treatment.

AN69 Standard

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged ≥ 18 years old.
  • A diagnosis of a confirmed, defined by a positive rt-PCR for SARS CoV-2, or suspected COVID-19 disease, with suggestive findings on a chest CT scan.
  • Patients on mechanical ventilation.
  • The presence of an informed consent signed by the next of kin.
  • Patients with KDIGO AKI stage 2: defined by a rise in creatinine 2-2.9 times baseline and/or a urinary output less than 0.5 ml/kg/hr for 12 hours, with failure after a furosemide stress test.
  • The use of vasopressor, any dose.
  • Complete medical history and complete laboratories.

You may not qualify if:

  • Chronic kidney disease KDIGO stage 4, 5, or 5D.
  • Next of kin unwilling or patient unwilling to participate.
  • Patients with a life expectancy of fewer than 72 hours according to the attending physician criteria.
  • Patients older than 75 years.
  • Patients with SOFA \> 11.
  • Patients with severe liver failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

RECRUITING

Related Publications (4)

  • Ronco C, Reis T. Kidney involvement in COVID-19 and rationale for extracorporeal therapies. Nat Rev Nephrol. 2020 Jun;16(6):308-310. doi: 10.1038/s41581-020-0284-7.

    PMID: 32273593RESULT

  • Ronco C, Reis T, De Rosa S. Coronavirus Epidemic and Extracorporeal Therapies in Intensive Care: si vis pacem para bellum. Blood Purif. 2020;49(3):255-258. doi: 10.1159/000507039. Epub 2020 Mar 13. No abstract available.

    PMID: 32172242RESULT

  • RENAL Replacement Therapy Study Investigators; Bellomo R, Cass A, Cole L, Finfer S, Gallagher M, Lo S, McArthur C, McGuinness S, Myburgh J, Norton R, Scheinkestel C, Su S. Intensity of continuous renal-replacement therapy in critically ill patients. N Engl J Med. 2009 Oct 22;361(17):1627-38. doi: 10.1056/NEJMoa0902413.

    PMID: 19846848RESULT

  • Morgera S, Haase M, Kuss T, Vargas-Hein O, Zuckermann-Becker H, Melzer C, Krieg H, Wegner B, Bellomo R, Neumayer HH. Pilot study on the effects of high cutoff hemofiltration on the need for norepinephrine in septic patients with acute renal failure. Crit Care Med. 2006 Aug;34(8):2099-104. doi: 10.1097/01.CCM.0000229147.50592.F9.

    PMID: 16763508RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Olynka Vega Vega, MD

CONTACT

5554870900olynkavega@hotmail.com

Ricardo Correa Rotter, MD

CONTACT

5554870900

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Group allocation for the AN-69 Oxiris membrane or the standard AN-69 membrane will be done by randomization before starting each CRRT treatment. This process will be performed through Epidat 4.2 software by one of the researchers from the Instituto Nacional de Ciencias Médicas y Nutrición, Salvador Zubirán.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized,open-label, controlled trial in critically ill patients with suspected or confirmed COVID-19 disease, AKI, and criteria for continuous renal replacement therapy initiation admitted in any of the two participating institutions. Patients meeting inclusion criteria will be randomized to receive CRRT with AN69-Oxiris membrane or standard AN69 membrane during a 72h period.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2020

First Posted

October 22, 2020

Study Start

October 2, 2020

Primary Completion

December 30, 2021

Study Completion

March 30, 2022

Last Updated

October 22, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

ME(1)