Continuous renal replacement therapy with oXiris
DeviceContinuous renal replacement therapy with oXiris in patient with septic shock
NCT Number: NCT04073771
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Zhongda Hospital, Southeast University, Nanjing, Jiangsu, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Continuous renal replacement therapy with oXiris in patient with septic shock
Time frame: 28 days
28-day mortality
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)
Time frame: 72 hours after Continuous Renal Replacement Therapy initiation
Changes from baseline to 72 hours in Sepsis-related Organ Failure Assessment(SOFA) Score
Time frame: 72 hours after Continuous Renal Replacement Therapy initiation
Norepinephrine dose or equivalent at 72 hours after Continuous Renal Replacement Therapy initiation
Time frame: 72 hours after Continuous Renal Replacement Therapy initiation
Difference of Norepinephrine dose at 72 hours compared with Continuous Renal Replacement Therapy initiation
Time frame: Day 28
Vasopressor-free days to day 28
Time frame: 72 hours after Continuous Renal Replacement Therapy initiation
Lactate concentration level at 72 hours after Continuous Renal Replacement Therapy initiation initiation
Time frame: through study completion, an average of 1 month
All cause mortality in ICU
Time frame: Day 28
Total length of mechanical ventilation free days up to to day 28
Time frame: Day 28
Total length of Continuous Renal Replacement Therapy to day 28
Southeast University, China
Other
A Multiple Centre, Cohort Study of New Continuous Renal Replacement Therapy (CRRT) Membranes oXiris for Patients With Septic Shock
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06363149
Blood Coagulation Disorders, Critical Illness
Lucknow, Uttar Pradesh, India
View Trial DetailsNCT07711405
Infections, Inflammation
Istanbul, Gaziosmanpasa, Turkey (Türkiye)
View Trial DetailsNCT07695337
Infections, Inflammation
Banhā, Qalyubia Governorate, Egypt
View Trial DetailsNCT05824767
Infections, Inflammation
Albuquerque, New Mexico, United States
View Trial Details