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| ID | Type | Description | Link |
|---|---|---|---|
| 18CECACAP1004 | Other Grant/Funding Number | Zhongda Hospital, Southeast University, |
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| Name | Class |
|---|---|
| Baxter Healthcare Corporation | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort study | Patients with septic shock undergoing continuous renal replacement therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous renal replacement therapy with oXiris | Device | Continuous renal replacement therapy with oXiris in patient with septic shock |
|
| Measure | Description | Time Frame |
|---|---|---|
| 28-day mortality | 28-day mortality | 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) | 72 hours after Continuous Renal Replacement Therapy initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| VIS-Norepinephrine dose or equivalent |
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Inclusion Criteria:
Exclusion Criteria:
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Septic shock patients due to abdominal or pneumonia( Gram-negative bacterial infection or suspected GNB infection) treated by CRRT
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongda Hospital, Southeast University | Nanjing | Jiangsu | 210009 | China | ||
| Department of Nephrology, Sichuan University West ChinaHospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30135570 | Background | 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. | |
| 28898482 | Background | 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. |
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there is a plan to make individual participant data (IPD) available to other researchers
Starting 6 months after publication
The corresponding author will review requests form and provide the IPD
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| ID | Term |
|---|---|
| D000079664 | Continuous Renal Replacement Therapy |
| ID | Term |
|---|---|
| D017582 | Renal Replacement Therapy |
| D013812 | Therapeutics |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
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Norepinephrine dose or equivalent at 72 hours after Continuous Renal Replacement Therapy initiation |
| 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 | 72 hours after Continuous Renal Replacement Therapy initiation |
| Vasopressor-free days | Vasopressor-free days to day 28 | Day 28 |
| 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 |
| ICU mortality | All cause mortality in ICU | through study completion, an average of 1 month |
| mechanical ventilation free days | Total length of mechanical ventilation free days up to to day 28 | Day 28 |
| Total length of Continuous Renal Replacement Therapy | Total length of Continuous Renal Replacement Therapy to day 28 | Day 28 |
| Chengdu |
| Sichuan |
| China |
| 31443997 | Background | 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. |
| 27686355 | Background | 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. |
| 29273917 | Background | 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. |
| 30304428 | Background | 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. |
| 28407544 | Background | 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. |
| 8844239 | Background | 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. |
| 26195505 | Result | 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.04360514. Epub 2015 Jul 20. |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |