SepsisMOSAKINCT03914586
The Membrane Adsorbing OXiris Filter in Septic Patients With AKI
An observational study of Sepsis and Acute Renal Failure, run by FRANCO TURANI at 1 site in Italy.
Trial summary
Patients with Sepsis / Septic Shock and AKI are submitted to Continuous Renal Replacement Therapy with the oXiris filter . The pro- inflammatory mediators , the endotoxin , interleukin 10 , the main cardiorespiratory indices and renal parameters are evaluated at the entry of the study and at the end of the treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis, Acute Renal Failure
- What is being tested?
- oXiris filter
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 10 Jan 2019to 30 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sepsis /septic shock and AKI
Who may be able to join
- Diagnosis of sepsis or septic shock (Sepsis III)
- Mechanical Ventilation or non Invasive ventilation with PaO2 /FIO2 < 200.
- Renal failure ( AKI ≥ 1)
- Endotoxin ( EAA ) : EAA ≥ 0.6 -0.9 > or IL6 > 150 pg/mL
Who cannot join
- Pregnancy;
- Age < 18 years 75>
- Chronic Renal failure or previous CRRT
- Immunological disease or immunosuppressive drugs or EAA < 0.6 with IL 6 in the normal range.
- CGS < 8 due to hemorrhagic or ischemic event.
- ECMO v-v or a-v or ECCO2 removal.
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- No resolution of the surgical source of infection
- Terminal condition
- Any contraindication to heparin and other anticoagulant.
- Other pathological conditions in which the oXiris filter is not indicated and other therapeutic options are required. (eg . Hepatic failure , Cardiac failure )
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Franco Turani
Rome, RM, 00152
FRANCO TURANI, MD, 00393484725073, turani.franco44@gmail.com
About this study
Official title: The OXIRIS Filter in Septic Shock : the Adsorption of Endotoxin and Cytokines Improves the Haemodynamic , the Renal Function , and the Metabolic Response
Patients with Sepsis / Septic Shock and AKI are submitted to Continuous Renal Replacement Therapy with the oXiris filter . The pro- inflammatory mediators , the endotoxin , interleukin 10 , the main cardiorespiratory indices and renal parameters are evaluated at the entry of the study and at the end of the treatment.
Read the detailed description
Patients with a diagnosis of sepsis or septic shock Gram + , Gram - and acute renal failure All patients are submitted to Continuous Renal Replacement Therapy with the treated heparin-coated membrane (oXiris;Baxter );
- Citrate Anticoagulation or Heparin with thromboelasthograpy monitoring .
- Hemodynamic monitoring with dynamic parameters ( Cardiac Index ,Stroke Volume Variation , Pulse Pressure Variation ) and Echocardiography
- Indirect Calorimetry ( before Continuous Renal Replacement Therapy and after 1 hour stopping Continuous Renal Replacement Therapy )
- Laboratory: white blood cell, creatinine, procalcitonin, Interleukin -6, Interleukin -10, Endotoxin , Lactate, diuresis, tromboelastography (post filter and arterial sample ) and dosage of Plasminogen Activator Inhibitor -1 at the same sites.
- Conditions
- Sepsis, Acute Renal Failure
- Being tested
- oXiris filter
- Keywords
- Sepsis, Acute Renal Failure, Extra Corporeal Therapy
- Medical subject headings
- Sepsis, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oXiris filterDevice
Continuous Renal Replacement Therapy with oXiris filter
| Study group | Role | What they receive |
|---|---|---|
| Septic patients with AKI | Patients with sepsis /septic shock ( Sepsis III ) and AKI submitted to Continuous Renal Replacement Therapy with the adsorbing membrane oXiris. Receives: Device: oXiris filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamic Data
Changes of vasoactive drugs concentration (micr/Kg/min)
Measured: At the 24 - 48 hours after starting of the treatment
Renal Data
Changes of Urinary Out Put ( mL/ 24 hours)
Measured: At the 24 - 48 hours after starting of the treatment
Respiratory Data
Changes of P/F ratio
Measured: At the 24 - 48 hours after starting of the treatment
Calorimetric data
Changes of VO2 (mL / min)
Measured: At the 24 - 48 hours after starting of the treatment
Secondary outcomes (4)
Inflammatory data
Changes of Endotoxin ( EAA measurement )
Measured: At the 24 - 48 hours after starting of the treatment
Coagulation data
Changes of the PAI-1 ( ng /mL)
Measured: At the 24 - 48 hours after starting of the treatment
Cytokines Data
IL 6 (pg/mL)
Measured: At the 24 - 48 hours after starting of the treatment
Cytokines data
IL 10 (pg/mL)
Measured: At the 24 - 48 hours after starting of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start10 Jan 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FRANCO TURANI
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor-investigator, FRANCO TURANI, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914586
- Sponsor's protocol ID
- 418/CE Lazio 1
- Acronym
- MOSAKI
- Status last verified
- Apr 2019
- First submitted
- 11 Apr 2019
- Last updated
- 2 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 29728790Turani F, Barchetta R, Falco M, Busatti S, Weltert L. Continuous Renal Replacement Therapy with the Adsorbing Filter oXiris in Septic Patients: A Case Series. Blood Purif. 2019;47 Suppl 3:1-5. doi: 10.1159/000499589. Epub 2019 Apr 12.
PubMed 30982024
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The OXIRIS Filter in Septic Shock : the Adsorption of Endotoxin and Cytokines Improves the Haemodynamic , the Renal Function , and the Metabolic Response
- ClinicalTrials.gov ID
- NCT03914586
- Acronym / sponsor ID
- MOSAKI / 418/CE Lazio 1
- Conditions
- Sepsis, Acute Renal Failure
- Keywords
- Sepsis, Acute Renal Failure, Extra Corporeal Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- FRANCO TURANIUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with Sepsis / Septic Shock and AKI are submitted to Continuous Renal Replacement Therapy with the oXiris filter . The pro- inflammatory mediators , the endotoxin , interleukin 10 , the main cardiorespiratory indices and renal parameters are evaluated at the entry of the study and at the end of the treatment.
Detailed description
Patients with a diagnosis of sepsis or septic shock Gram + , Gram - and acute renal failure All patients are submitted to Continuous Renal Replacement Therapy with the treated heparin-coated membrane (oXiris;Baxter );
- Citrate Anticoagulation or Heparin with thromboelasthograpy monitoring .
- Hemodynamic monitoring with dynamic parameters ( Cardiac Index ,Stroke Volume Variation , Pulse Pressure Variation ) and Echocardiography
- Indirect Calorimetry ( before Continuous Renal Replacement Therapy and after 1 hour stopping Continuous Renal Replacement Therapy )
- Laboratory: white blood cell, creatinine, procalcitonin, Interleukin -6, Interleukin -10, Endotoxin , Lactate, diuresis, tromboelastography (post filter and arterial sample ) and dosage of Plasminogen Activator Inhibitor -1 at the same sites.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Septic patients with AKI | – | Device: oXiris filterPatients with sepsis /septic shock ( Sepsis III ) and AKI submitted to Continuous Renal Replacement Therapy with the adsorbing membrane oXiris. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sepsis /septic shock and AKI
Key inclusion criteria (4 listed)
- Diagnosis of sepsis or septic shock (Sepsis III)
- Mechanical Ventilation or non Invasive ventilation with PaO2 /FIO2 < 200.
- Renal failure ( AKI ≥ 1)
- Endotoxin ( EAA ) : EAA ≥ 0.6 -0.9 > or IL6 > 150 pg/mL
Key exclusion criteria (10 listed)
- Pregnancy;
- Age < 18 years 75>
- Chronic Renal failure or previous CRRT
- Immunological disease or immunosuppressive drugs or EAA < 0.6 with IL 6 in the normal range.
- CGS < 8 due to hemorrhagic or ischemic event.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oXiris filterContinuous Renal Replacement Therapy with oXiris filter | Device | Septic patients with AKI |
Primary outcome
Hemodynamic Data
Time frame: At the 24 - 48 hours after starting of the treatment
Changes of vasoactive drugs concentration (micr/Kg/min)
Renal Data
Time frame: At the 24 - 48 hours after starting of the treatment
Changes of Urinary Out Put ( mL/ 24 hours)
Respiratory Data
Time frame: At the 24 - 48 hours after starting of the treatment
Changes of P/F ratio
Calorimetric data
Time frame: At the 24 - 48 hours after starting of the treatment
Changes of VO2 (mL / min)
4 secondary outcomes
Inflammatory data
Time frame: At the 24 - 48 hours after starting of the treatment
Coagulation data
Time frame: At the 24 - 48 hours after starting of the treatment
Cytokines Data
Time frame: At the 24 - 48 hours after starting of the treatment
Cytokines data
Time frame: At the 24 - 48 hours after starting of the treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Background: PubMed 29728790Malard 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.
- Background: PubMed 30982024Turani F, Barchetta R, Falco M, Busatti S, Weltert L. Continuous Renal Replacement Therapy with the Adsorbing Filter oXiris in Septic Patients: A Case Series. Blood Purif. 2019;47 Suppl 3:1-5. doi: 10.1159/000499589. Epub 2019 Apr 12.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Acute Renal Failure, run by FRANCO TURANI at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic Data (time frame: At the 24 - 48 hours after starting of the treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03914586, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2019.