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comparing circuit life between modified membrane and standard membrane in liver failure patients

Comparing Circuit Life between Modified AN69ST Membrane vs. Standard Membrane Dialyser In Liver Failure Patients with Severe Acute Kidney Injury Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000788178
Acronym
The MODIFY Trial
Enrollment
10
Registered
2019-05-28
Start date
2019-09-10
Completion date
2020-06-30
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In patients who have both liver and kidney failure, average circuit life of continuous renal replacement therapy (CRRT) is approximately half compared to other group of patients receiving CRRT due to circuit clotting. However, liver failure patients can’t receive anticoagulants to prevent circuit clotting because of high risk for developed toxicity and bleeding. Modified membrane (oXiris®) is coated with anti-clotting material and has ability to remove cytokine in blood. This study is a pilot, single-center, prospective, randomized, crossover, open-label, clinical controlled trial which aim to assess the efficacy of modified membrane (oXiris®) compared to standard membrane and we hypothesized that modified membrane (oXiris®) has ability to prolong CRRT circuit life compared to standard membrane dialyser and decrease the blood level of cytokines.

Interventions

Liver failure patients with severe acute kidney injury (AKI) admitted in ICU at the Austin Hospital and treated with continuous renal replacement therapy(CRRT) will be randomly allocated in a 1:1 ratio to receive either modified AN69ST membrane (oXiris®) or standard CRRT membrane. After the first filter has clotted, the second filter will be introduced and will be the one not used for the first treatment. After these two filters have been used, the study will be ceased in that patient. However,

Liver failure patients with severe acute kidney injury (AKI) admitted in ICU at the Austin Hospital and treated with continuous renal replacement therapy(CRRT) will be randomly allocated in a 1:1 ratio to receive either modified AN69ST membrane (oXiris®) or standard CRRT membrane. After the first filter has clotted, the second filter will be introduced and will be the one not used for the first treatment. After these two filters have been used, the study will be ceased in that patient. However, if the patient continues to require CRRT, they will continue to receive such treatment with a standard CRRT membrane as is usual care. There is no wash-out period between two filters. An approximate duration for the time study per patient is 2 days All other aspects of RRT will follow ICU protocols prescribed by intensivist. The protocols include: blood flow of 200 ml/min for CVVHDF, Prismaflex machine, effluent flow rate of 2000 ml/hr, removal of fluid as needed according to clinical needs. we will audit of nurse notes and CRRT prescription order to assess fidelity.

Sponsors

Austin Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients have liver failure and severe AKI requiring CRRT AND 2. Patients have contraindications for regional citrate anticoagulant 3. Patients have contraindications for systemic heparin 4. Patient who, in the judgment of the treating clinician, are expected to continue CRRT greater than or equal to 48 h

Exclusion criteria

1. Patient age is < 18 years 2. Pregnancy 3. DNR (do not resuscitate) DNI (do not intubate) orders 4. Death is deemed imminent or inevitable during this admission, and either the attending physician, patient or substitute decision-maker is not committed to active treatment 5. Patient needs to receive systemic anticoagulation for other indications

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026