A Multiple Centre, Cohort Study of New CRRT Membranes oXiris for Patients With Septic Shock

Acute Kidney Injury Due to Sepsis (Disorder) Clinical Trial

Official title:

A Multiple Centre, Cohort Study of New Continuous Renal Replacement Therapy (CRRT) Membranes oXiris for Patients With Septic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04073771
• Other study ID #: 2018ZDSYLL152-P01
• Secondary ID: 18CECACAP1004
• Status: Completed
• Start date: September 21, 2019
• Est. completion date: October 31, 2021

Study information

• Verified date: November 2022
• Source: Southeast University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 590
• Est. completion date: October 31, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• >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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Kidney Injury Due to Sepsis (Disorder)
• Sepsis
• Shock, Septic

Intervention

Device:
• Continuous renal replacement therapy with oXiris
Continuous renal replacement therapy with oXiris in patient with septic shock

Locations

Country	Name	City	State
China	Department of Nephrology, Sichuan University West ChinaHospital	Chengdu	Sichuan
China	Zhongda Hospital, Southeast University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Southeast University, China	Baxter Healthcare Corporation

Country where clinical trial is conducted

China, 

References & Publications (9)

Bouchard 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.04 — View Citation

Dellinger 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. — View Citation

Fani 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. — View Citation

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. — View Citation

Peerapornratana 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. — View Citation

Perez-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. — View Citation

SepNet 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. Erratum In: Intensive Care Med. 2017 Dec 1;: — View Citation

Shum 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. — View Citation

Vincent 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	28-day mortality	28-day mortality	28 days
Primary	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)	72 hours after Continuous Renal Replacement Therapy initiation
Secondary	Changes of Sepsis-related Organ Failure Assessment(SOFA) Score	Changes from baseline to 72 hours in Sepsis-related Organ Failure Assessment(SOFA) Score	72 hours after Continuous Renal Replacement Therapy initiation
Secondary	VIS-Norepinephrine dose or equivalent	Norepinephrine dose or equivalent at 72 hours after Continuous Renal Replacement Therapy initiation	72 hours after Continuous Renal Replacement Therapy initiation
Secondary	Change of Norepinephrine dose Over Time	Difference of Norepinephrine dose at 72 hours compared with Continuous Renal Replacement Therapy initiation	72 hours after Continuous Renal Replacement Therapy initiation
Secondary	Vasopressor-free days	Vasopressor-free days to day 28	Day 28
Secondary	Lactate concentration at 72 hours	Lactate concentration level at 72 hours after Continuous Renal Replacement Therapy initiation initiation	72 hours after Continuous Renal Replacement Therapy initiation
Secondary	ICU mortality	All cause mortality in ICU	through study completion, an average of 1 month
Secondary	mechanical ventilation free days	Total length of mechanical ventilation free days up to to day 28	Day 28
Secondary	Total length of Continuous Renal Replacement Therapy	Total length of Continuous Renal Replacement Therapy to day 28	Day 28