[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hemoperfusion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hemoperfusion":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100647875","biological-effects-of-hemoadsorption-in-septic-shock-100647875",false,"NCT07715110","Biological Effects of Hemoadsorption in Septic Shock","Biological and Immunomodulatory Effect of Hemoadsorption With Macroporous Resin Cartridges in Septic Shock and Refractory Septic Shock Two Parallel Open-label Randomized Pilot Trials.","Bio-HA380","Inclusion Criteria:\n\n* All of the following:\n\n  * Age ≥ 18 years.\n  * Diagnosis of septic shock per Sepsis-3, with an identified or highly probable infectious focus.\n  * Meeting the operational definition of one of the two severity strata (SS or RSS) detailed in 6.1.\n  * Onset of septic shock within the last 24 hours (applied identically to both strata).\n  * Large-bore vascular access.\n  * Informed consent signed by the legal representative.\n\nExclusion Criteria:\n\n* Decision to limit life-sustaining therapy made or anticipated within the next 48 hours.\n* Absolute contraindication to anticoagulation with heparin and citrate.\n* Predominant non-septic shock (hemorrhagic, primary cardiogenic, obstructive).\n* Ongoing pregnancy.\n* Platelet count \\\u003C 20,000\u002FµL.\n* Significant pharmacological immunosuppression: chronic corticosteroids at doses \\> 20 mg\u002Fday prednisone equivalent, biologics within the last 6 months, cytotoxic chemotherapy within the last 4 weeks.\n* Solid organ or hematopoietic stem cell transplantation.\n* Concurrent participation in another clinical trial.","ALL","18 Years",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24],"NA","Septic shock is the most severe form of sepsis and continues to carry an in-hospital mortality of between 30% and 50% despite advances in compliance with the Surviving Sepsis Campaign care bundles.\n\nThe pathophysiology of septic shock is dominated by an uncontrolled immuno-inflammatory response with massive release of mediators, pro- and anti-inflammatory cytokines5, DAMPs (damage-associated molecular patterns) and PAMPs (pathogen-associated molecular patterns), producing vasoplegia, endothelial dysfunction, glycocalyx damage and, in many patients, a subsequent immunoparalysis phase that increases the risk of nosocomial infections and late mortality.\n\nEndothelial damage and glycocalyx degradation are central elements in the pathophysiology of septic shock. The endothelial glycocalyx, a layer of proteoglycans and glycosaminoglycans approximately 0.5 µm thick on the luminal surface of the endothelium, regulates vascular permeability, leukocyte adhesion and the inflammatory response. During sepsis, the release of metalloproteinases, heparanase and other inflammatory mediators causes the shedding of syndecan-1, heparan sulfate and other glycocalyx molecules into the circulation. This process is associated with increased capillary permeability, interstitial edema, third-space fluid leakage, and progression to multiorgan failure. Elevated plasma syndecan-1 levels correlate with greater severity of septic shock, development of acute respiratory distress syndrome (ARDS), extrapulmonary organ dysfunction, and mortality. In parallel, the release of angiopoietin-2 by activated endothelial cells antagonizes Tie2 signaling, destabilizes the endothelial barrier and amplifies vascular dysfunction.\n\nSelective modulation of the immune response through extracorporeal adsorption of medium-sized mediators (5-60 kDa) is an adjunctive strategy whose biological rationale is well established and whose hemodynamic effect has been described by multiple authors. The HA380 HA cartridge (Jafron Biomedical), specifically, uses a synthetic neutral macroporous polymer resin with high affinity for cytokines in the 10-60 kDa range, especially IL-6, TNF-α, IL-8 and IL-10. The device is connected to an extracorporeal therapy circuit (in this protocol, always integrated into a continuous renal replacement therapy \\[CRRT\\] circuit) and operates for 4-6 hours per cartridge. Removal of proinflammatory cytokines (IL-6, TNF-α, IL-8) with HA380 also aims to reduce their effect on endothelial damage, and recent studies with other cytokine adsorbents have demonstrated the ability to remove circulating angiopoietin-2. Although the specific literature on the effect of HA380 on recovery of glycocalyx integrity is limited, reducing the burden of cytokines and endotoxic mediators could attenuate the glycocalyx degradation cascade and contribute to the hemodynamic stabilization observed in clinical studies. This mechanism provides an additional biological rationale for assessing biomarkers of endothelial dysfunction (angiopoietin-2, syndecan-1, soluble thrombomodulin) as secondary variables in the present study.\n\nWithin the spectrum of septic shock, this protocol distinguishes two clinically and biologically relevant severity strata: 1) established septic shock as per Sepsis-3 criteria who, despite requiring vasopressor support and showing hyperlactatemia, do not meet the thresholds of refractoriness. 2) refractory septic shock, a particularly severe subgroup in which standard resuscitation measures-guided fluid therapy, vasopressors, source control, early antibiotic therapy, and hydrocortisone-are insufficient to reverse tissue hypoperfusion and progressive organ dysfunction.\n\nPrimary objective To establish whether HA380 hemoadsorption yields a more desirable overall outcome than concurrent standard of care, within each severity stratum, using a pre-specified hierarchical ordinal DOOR endpoint.",[27,28,29,30,31],"Septic Shock, Vasopressor Resistance","Multiple Organ Dysfunction","Sepsis","Hemoperfusion","Hemoadsorption",[33,31,29,34,35,36],"Randomized","Septic shock","Refractory septic shock","Multiple Organ dysfunction","NOT_YET_RECRUITING","2026-07-15",{"date":40,"type":41},"2026-07-20","ACTUAL",{"date":43,"type":21},"2027-01-07",{"date":45,"type":21},"2029-06-30",{"name":47,"class":48},"Miguel Sanchez Garcia","OTHER",{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":73},"100442670","hemoperfusion-in-critical-patients-with-septic-multiorgan-dysfunction-syndrome-100442670","NCT05044403","Hemoperfusion in Critical Patients With Septic Multiorgan Dysfunction Syndrome.","Clinical Impact of Hemoperfusion With a Neutral Macroporous Resin Cartridge as Adjunctive Treatment in Septic Patients With Multiorgan Dysfunction Syndrome (MODS) Admitted to Intensive Care Units.","Inclusion Criteria:\n\n* Patients with a sepsis diagnosis, according to the diagnostic criteria of the International Sepsis-3 Consensus Conference, and without response to the treatment of septic shock who meet the following conditions:\n* Sepsis of abdominal origin with controlled infectious focus.\n* Noradrenaline dose\\> 0.5 µg \u002F kg \u002F min to maintain adequate organ perfusion after optimization of fluid therapy.\n* Dysfunction of two or more organs with SOFA ≥ 9 (5).\n* Blood lactate ≥ 2 mmol \u002F L.\n* Procalcitonin (PCT)\\> 10 ng \u002F mL.\n* CRP\\> 100 mg \u002F L.\n* IL-6\\> 2000 pg \u002F ml.\n\nExclusion Criteria:\n\n* Age under 18 years or over 80 years.\n* Pregnancy or breastfeeding.\n* Terminally ill patients or with a life expectancy of less than 48 hours.\n* Thrombocytopenia \\\u003C60,000 \u002F mm3.\n* Pancytopenia.\n* Severe coagulopathy with high risk of bleeding.\n* Inclusion in another research protocol.\n* In case of re-entry during the study period, only the first admission will be included.\n* Use of another haemoperfusion device.","80 Years",{"count":58,"type":21},48,[24],"Low-level interventional clinical trial to evaluate the effectiveness and safety of extracorporeal support with hemoperfusion in critical patients with septic multiorgan dysfunction syndrome.",[30,62,29],"Multiorgan Failure","RECRUITING","2025-06-04",{"date":66,"type":41},"2025-06-10",{"date":68,"type":41},"2023-03-01",{"date":70,"type":21},"2025-12-20",{"name":72,"class":48},"Hospital Clinic of Barcelona",1]