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Covid19
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Efficacy and Safety of a Highly Selective Semipermeable Membrane (AN-69 Oxiris) vs (Standard AN-69) in COVID-19

Sponsored by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

About this trial

Last updated 5 years ago

Study ID

NMM-3401-20-20-1

Status

Unknown status

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 75 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

1. Patients aged ≥ 18 years old.

2. 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.

3. Patients on mechanical ventilation.

4. The presence of an informed consent signed by the next of kin.

5. 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.

6. The use of vasopressor, any dose.

7. Complete medical history and complete laboratories.

No

Exclusion Criteria

1. Chronic kidney disease KDIGO stage 4, 5, or 5D.

2. Next of kin unwilling or patient unwilling to participate.

3. Patients with a life expectancy of fewer than 72 hours according to the attending physician criteria.

4. Patients older than 75 years.

5. Patients with SOFA > 11.

6. Patients with severe liver failure.

Locations

Location

Status

Recruiting