Acute Kidney Injury Due to Sepsis (Disorder)NCT04073771
A Multiple Centre, Cohort Study of New CRRT Membranes oXiris for Patients With Septic Shock
An observational study of Acute Kidney Injury Due to Sepsis (Disorder), run by Southeast University, China at 2 sites in China.
Trial summary
The objectives of this study are to determine whether Continuous Renal Replacement Therapy (CRRT) with oXiris in patients with septic shock would improve clinical outcomes such as the sepsis-related organ failure assessment (SOFA) , hemodynamic, mortality compared CRRT with conventional membrane. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury Due to Sepsis (Disorder)
- What is being tested?
- Continuous renal replacement therapy with oXiris
- Type of treatment
- Medical device
- How many people
- 590 participants
- Where
- 2 sitesChina
- Study dates
- 21 Sep 2019to 31 Oct 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Septic shock patients due to abdominal or pneumonia( Gram-negative bacterial infection or suspected GNB infection) treated by CRRT
Who may be able to join
- >18 Years
- Treated by CRRT using oXiris or conventional membrane
- SOFA cardiovascular Score ≥ 3
- Septic shock due to abdominal or pneumonia( Gram-negative bacterial infection or suspected GNB infection)
- Written informed consent
Who cannot join
- Chronic Kidney Disease
- Renal replacement therapy (RRT) in the last 30 days
- Pregnancy
- Immunosuppressive treatment or steroids (prednisone > 0.5 mg/kg/day or equivalent).
- Autoimmune disorder.
- Transplant receptor.
- Inclusion in other ongoing studies within the last 30 days.
- Coexisting illness with a high probability of death
Trial locations and contacts
2 sites in 1 country.
China2 sites
Department of Nephrology, Sichuan University West ChinaHospital
Chengdu, Sichuan
Zhongda Hospital, Southeast University
Nanjing, Jiangsu, 210009
About this study
Official title: A Multiple Centre, Cohort Study of New Continuous Renal Replacement Therapy (CRRT) Membranes oXiris for Patients With Septic Shock
The objectives of this study are to determine whether Continuous Renal Replacement Therapy (CRRT) with oXiris in patients with septic shock would improve clinical outcomes such as the sepsis-related organ failure assessment (SOFA) , hemodynamic, mortality compared CRRT with conventional membrane.
Read the detailed description
Sepsis is the leading cause of death in ICU, resulting in multi-organ failure in critically ill patients. Patients with septic shock combined sepsis-associated Acute kidney injury (AKI)have even poorer outcome.
Endotoxin activity, inflammation and immune dysfunction, have been consider relevant to their pathogenesis of sepsis. High levels of Inflammation are associated with worse clinical outcomes. However, all studies of anti-inflammation treatment in sepsis patient are failed and anti-inflammation treatment of sepsis still remains controversial.
oXiris is a new filter with adsorptive membrane, which removes endotoxin and inflammatory mediator from plasma. But current evidence of oXiris is limited, and only some small sample studies have proved that it can improve the haemodynamics and the sepsis-related organ failure assessment(SOFA) score.
Our hypothesis was that oXiris would be associated with better clinical outcomes, such as decreased SOFA score, improved survival rate, better hemodynamic, and improved of organ function.
- Being tested
- Continuous renal replacement therapy with oXiris
- Keywords
- Septic shock, AKI, CRRT
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous renal replacement therapy with oXirisDevice
Continuous renal replacement therapy with oXiris in patient with septic shock
| Study group | Role | What they receive |
|---|---|---|
| Cohort study | Patients with septic shock undergoing continuous renal replacement therapy Receives: Device: Continuous renal replacement therapy with oXiris |
What is being measured
The primary outcome is the main question the study is designed to answer.
28-day mortality
28-day mortality
Measured: 28 days
The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours
The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours(Scores Range 0-4, higher values represent a worse outcome)
Measured: 72 hours after Continuous Renal Replacement Therapy initiation
Secondary outcomes (8)
Changes of Sepsis-related Organ Failure Assessment(SOFA) Score
Changes from baseline to 72 hours in Sepsis-related Organ Failure Assessment(SOFA) Score
Measured: 72 hours after Continuous Renal Replacement Therapy initiation
VIS-Norepinephrine dose or equivalent
Norepinephrine dose or equivalent at 72 hours after Continuous Renal Replacement Therapy initiation
Measured: 72 hours after Continuous Renal Replacement Therapy initiation
Change of Norepinephrine dose Over Time
Difference of Norepinephrine dose at 72 hours compared with Continuous Renal Replacement Therapy initiation
Measured: 72 hours after Continuous Renal Replacement Therapy initiation
Vasopressor-free days
Vasopressor-free days to day 28
Measured: Day 28
Lactate concentration at 72 hours
Lactate concentration level at 72 hours after Continuous Renal Replacement Therapy initiation initiation
Measured: 72 hours after Continuous Renal Replacement Therapy initiation
ICU mortality
All cause mortality in ICU
Measured: through study completion, an average of 1 month
mechanical ventilation free days
Total length of mechanical ventilation free days up to to day 28
Measured: Day 28
Total length of Continuous Renal Replacement Therapy
Total length of Continuous Renal Replacement Therapy to day 28
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2019
- Study start21 Sep 2019
- Primary completion30 Jun 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Acute Kidney Injury Due to Sepsis (Disorder)Studies 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
- 590 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southeast University, China
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Songqiao Liu, Southeast University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073771
- Sponsor's protocol ID
- 2018ZDSYLL152-P01
- Other IDs
- 18CECACAP1004
- Status last verified
- Nov 2022
- First submitted
- 27 Aug 2019
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: there is a plan to make individual participant data (IPD) available to other researchers
Publications
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.
PubMed 30135570Shum HP, Chan KC, Tam CW, Yan WW, Chan TM. Impact of renal replacement therapy on survival in patients with KDIGO stage 3 acute kidney injury: A propensity score matched analysis. Nephrology (Carlton). 2018 Dec;23(12):1081-1089. doi: 10.1111/nep.13164.
PubMed 28898482Peerapornratana 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.
PubMed 31443997SepNet Critical Care Trials Group. Incidence of severe sepsis and septic shock in German intensive care units: the prospective, multicentre INSEP study. Intensive Care Med. 2016 Dec;42(12):1980-1989. doi: 10.1007/s00134-016-4504-3. Epub 2016 Sep 29.
PubMed 27686355Fani F, Regolisti G, Delsante M, Cantaluppi V, Castellano G, Gesualdo L, Villa G, Fiaccadori E. Recent advances in the pathogenetic mechanisms of sepsis-associated acute kidney injury. J Nephrol. 2018 Jun;31(3):351-359. doi: 10.1007/s40620-017-0452-4. Epub 2017 Dec 23.
PubMed 29273917Dellinger RP, Bagshaw SM, Antonelli M, Foster DM, Klein DJ, Marshall JC, Palevsky PM, Weisberg LS, Schorr CA, Trzeciak S, Walker PM; EUPHRATES Trial Investigators. Effect of Targeted Polymyxin B Hemoperfusion on 28-Day Mortality in Patients With Septic Shock and Elevated Endotoxin Level: The EUPHRATES Randomized Clinical Trial. JAMA. 2018 Oct 9;320(14):1455-1463. doi: 10.1001/jama.2018.14618.
PubMed 30304428Perez-Fernandez X, Sabater-Riera J, Sileanu FE, Vazquez-Reveron J, Ballus-Noguera J, Cardenas-Campos P, Betbese-Roig A, Kellum JA. Clinical variables associated with poor outcome from sepsis-associated acute kidney injury and the relationship with timing of initiation of renal replacement therapy. J Crit Care. 2017 Aug;40:154-160. doi: 10.1016/j.jcrc.2017.03.022. Epub 2017 Mar 30.
PubMed 28407544Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
PubMed 8844239Bouchard 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.
PubMed 26195505
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Centre, Cohort Study of New Continuous Renal Replacement Therapy (CRRT) Membranes oXiris for Patients With Septic Shock
- ClinicalTrials.gov ID
- NCT04073771
- Acronym / sponsor ID
- 2018ZDSYLL152-P01
- Keywords
- Septic shock, AKI, CRRT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 590 participants (actual)
- Lead sponsor
- Southeast University, ChinaUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 21 Sep 2019 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 29 Aug 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.
The objectives of this study are to determine whether Continuous Renal Replacement Therapy (CRRT) with oXiris in patients with septic shock would improve clinical outcomes such as the sepsis-related organ failure assessment (SOFA) , hemodynamic, mortality compared CRRT with conventional membrane.
Detailed description
Sepsis is the leading cause of death in ICU, resulting in multi-organ failure in critically ill patients. Patients with septic shock combined sepsis-associated Acute kidney injury (AKI)have even poorer outcome.
Endotoxin activity, inflammation and immune dysfunction, have been consider relevant to their pathogenesis of sepsis. High levels of Inflammation are associated with worse clinical outcomes. However, all studies of anti-inflammation treatment in sepsis patient are failed and anti-inflammation treatment of sepsis still remains controversial.
oXiris is a new filter with adsorptive membrane, which removes endotoxin and inflammatory mediator from plasma. But current evidence of oXiris is limited, and only some small sample studies have proved that it can improve the haemodynamics and the sepsis-related organ failure assessment(SOFA) score.
Our hypothesis was that oXiris would be associated with better clinical outcomes, such as decreased SOFA score, improved survival rate, better hemodynamic, and improved of organ function.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort study | – | Device: Continuous renal replacement therapy with oXirisPatients with septic shock undergoing continuous renal replacement therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Septic shock patients due to abdominal or pneumonia( Gram-negative bacterial infection or suspected GNB infection) treated by CRRT
Key inclusion criteria (5 listed)
- >18 Years
- Treated by CRRT using oXiris or conventional membrane
- SOFA cardiovascular Score ≥ 3
- Septic shock due to abdominal or pneumonia( Gram-negative bacterial infection or suspected GNB infection)
- Written informed consent
Key exclusion criteria (8 listed)
- Chronic Kidney Disease
- Renal replacement therapy (RRT) in the last 30 days
- Pregnancy
- Immunosuppressive treatment or steroids (prednisone > 0.5 mg/kg/day or equivalent).
- Autoimmune disorder.
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 |
|---|---|---|
| Continuous renal replacement therapy with oXirisContinuous renal replacement therapy with oXiris in patient with septic shock | Device | Cohort study |
Primary outcome
28-day mortality
Time frame: 28 days
28-day mortality
The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours
Time frame: 72 hours after Continuous Renal Replacement Therapy initiation
The Sepsis-related Organ Failure Assessment(SOFA) cardiovascular Scores at 72 hours(Scores Range 0-4, higher values represent a worse outcome)
8 secondary outcomes
Changes of Sepsis-related Organ Failure Assessment(SOFA) Score
Time frame: 72 hours after Continuous Renal Replacement Therapy initiation
VIS-Norepinephrine dose or equivalent
Time frame: 72 hours after Continuous Renal Replacement Therapy initiation
Change of Norepinephrine dose Over Time
Time frame: 72 hours after Continuous Renal Replacement Therapy initiation
Vasopressor-free days
Time frame: Day 28
Lactate concentration at 72 hours
Time frame: 72 hours after Continuous Renal Replacement Therapy initiation
ICU mortality
Time frame: through study completion, an average of 1 month
mechanical ventilation free days
Time frame: Day 28
Total length of Continuous Renal Replacement Therapy
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2022.
- Background: PubMed 30135570Hoste 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.
- Background: PubMed 28898482Shum HP, Chan KC, Tam CW, Yan WW, Chan TM. Impact of renal replacement therapy on survival in patients with KDIGO stage 3 acute kidney injury: A propensity score matched analysis. Nephrology (Carlton). 2018 Dec;23(12):1081-1089. doi: 10.1111/nep.13164.
- Background: PubMed 31443997Peerapornratana 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.
- Background: PubMed 27686355SepNet Critical Care Trials Group. Incidence of severe sepsis and septic shock in German intensive care units: the prospective, multicentre INSEP study. Intensive Care Med. 2016 Dec;42(12):1980-1989. doi: 10.1007/s00134-016-4504-3. Epub 2016 Sep 29.
- Background: PubMed 29273917Fani F, Regolisti G, Delsante M, Cantaluppi V, Castellano G, Gesualdo L, Villa G, Fiaccadori E. Recent advances in the pathogenetic mechanisms of sepsis-associated acute kidney injury. J Nephrol. 2018 Jun;31(3):351-359. doi: 10.1007/s40620-017-0452-4. Epub 2017 Dec 23.
- Background: PubMed 30304428Dellinger RP, Bagshaw SM, Antonelli M, Foster DM, Klein DJ, Marshall JC, Palevsky PM, Weisberg LS, Schorr CA, Trzeciak S, Walker PM; EUPHRATES Trial Investigators. Effect of Targeted Polymyxin B Hemoperfusion on 28-Day Mortality in Patients With Septic Shock and Elevated Endotoxin Level: The EUPHRATES Randomized Clinical Trial. JAMA. 2018 Oct 9;320(14):1455-1463. doi: 10.1001/jama.2018.14618.
- Background: PubMed 28407544Perez-Fernandez X, Sabater-Riera J, Sileanu FE, Vazquez-Reveron J, Ballus-Noguera J, Cardenas-Campos P, Betbese-Roig A, Kellum JA. Clinical variables associated with poor outcome from sepsis-associated acute kidney injury and the relationship with timing of initiation of renal replacement therapy. J Crit Care. 2017 Aug;40:154-160. doi: 10.1016/j.jcrc.2017.03.022. Epub 2017 Mar 30.
- Background: PubMed 8844239Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.
- Results publication: PubMed 26195505Bouchard 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.
- Individual participant dataSharing planned: Yes. there is a plan to make individual participant data (IPD) available to other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury Due to Sepsis (Disorder), run by Southeast University, China at 2 sites in China.
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 5 inclusion and 8 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: finished, as of the sponsor's last update on 2 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
28-day mortality (time frame: 28 days). The study lists 2 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 NCT04073771, which also lists 9 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 Dec 2022.