[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659017":3},{"organization":4,"outcomesModule":7,"designInfo":29,"detailedDescription":32,"studyPopulation":33,"armGroups":34,"interventions":28,"overallOfficials":28,"centralContacts":41,"locations":47,"responsibleParty":62,"collaborators":28,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":28,"studyType":78,"phases":28,"briefSummary":79,"conditions":80,"keywords":84,"overallStatus":90,"whyStopped":28,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"The Second Affiliated Hospital of Hainan Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":28},[9,13],{"measure":10,"description":11,"timeFrame":12},"Ventilator-Free Days at Day 28 (VFD-28)","VFD-28 is defined as the number of days from Time Zero (T0) to day 28 that a patient is alive and successfully liberated from invasive mechanical ventilation (defined as being free from the ventilator for at least 48 consecutive hours). Patients who die within the 28-day observation period are assigned zero VFDs, regardless of their ventilation status prior to death.","Up to 28 days from Time Zero (T0)",{"measure":14,"description":15,"timeFrame":12},"Cumulative Incidence of Successful Liberation from Ventilation","Analyzed using a competing-risk model (treating death as a competing event) to evaluate the probability of successful weaning from invasive mechanical ventilation.",[17,21,24],{"measure":18,"description":19,"timeFrame":20},"Cumulative Fluid Balance","The daily net fluid balance evaluated to reflect the de-resuscitation trajectory. It is calculated by subtracting total fluid output (including net ultrafiltration from CRRT, if applicable) from total fluid intake.","From Day 0 to Day 7",{"measure":22,"description":23,"timeFrame":20},"Change in Oxygenation Index (PaO2\u002FFiO2 Ratio)","The daily worst PaO2\u002FFiO2 ratio measured to evaluate the trajectory of lung function and pulmonary edema resolution.",{"measure":25,"description":26,"timeFrame":27},"28-Day All-Cause Mortality","The proportion of patients who die from any cause within the 28-day observation period.","At Day 28",null,{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":30,"timePerspective":31,"maskingInfo":28},"COHORT","PROSPECTIVE","Background and Rationale Hypoalbuminemia is common in patients with sepsis-associated ARDS and alters colloid osmotic pressure, exacerbating pulmonary edema and prolonging mechanical ventilation. While human albumin administration during the de-resuscitation phase may support intravascular volume and facilitate fluid removal (via diuretics or CRRT), real-world evidence evaluating a structured, targeted albumin strategy specifically in this vulnerable subpopulation remains limited.\n\nStudy Design and Cohorts This is a single-center, prospective observational study with a historical control cohort. The study employs a before-and-after design to evaluate real-world clinical outcomes.\n\nHistorical Control Cohort: Eligible patients identified retrospectively who received usual clinical care (primarily crystalloid-based fluid management) prior to the routine implementation of the targeted albumin strategy. Any occasional albumin use in this cohort will be documented and adjusted for in statistical analyses.\n\nProspective Observational Cohort: Eligible patients receiving current standard of care, which includes human albumin administration (aiming for serum albumin ≥ 30 g\u002FL) and fluid de-resuscitation. Treatment decisions, including albumin dose, frequency, and fluid targets, remain entirely under the discretion of the treating clinical team.\n\nTime Origin (Time Zero, T0) Definition To strictly prevent immortal time bias, the study time origin (T0) is defined as the exact timestamp when a patient simultaneously fulfills all required eligibility conditions: (1) Sepsis-3 criteria met, (2) ARDS criteria met, (3) invasive mechanical ventilation active, and (4) confirmed serum albumin ≤ 30 g\u002FL. All baseline covariates, propensity score matching variables, and outcome observation windows strictly anchor to T0. If mechanical ventilation begins before T0, the actual ventilation start time is retained for the ventilation history but outcome computation (e.g., VFD-28) strictly starts at T0.\n\nExposure Definition (Observational Context) The primary exposure is management with a targeted human albumin strategy combined with fluid de-resuscitation. As an observational study, the protocol does not mandate therapy. Instead, it observes and records treatments delivered in routine clinical care. Data on albumin concentration, cumulative dose, fluid intake\u002Foutput, diuretic use, and CRRT net ultrafiltration are prospectively collected.\n\nOutcome Assessment and Statistical Analysis The primary outcome is Ventilator-Free Days at day 28 (VFD-28), calculated from T0. Patients who die within 28 days are assigned zero VFDs.\n\nTo mitigate confounding by indication and calendar time bias, a 1:1 Propensity Score Matching (PSM) will be utilized. Covariates (e.g., age, APACHE II, baseline SOFA, PaO2\u002FFiO2, lactate, and cumulative fluid balance) are strictly restricted to pre-T0 values to avoid overadjustment by post-treatment mediators.\n\nThe primary outcome (VFD-28) will be analyzed evaluating the absolute difference between matched groups. As a key secondary analysis, a Fine-Gray competing-risk model will be used to evaluate the cumulative incidence of successful liberation from ventilation, treating death as a competing event. Repeated measures (e.g., albumin levels, oxygenation) will be evaluated using generalized estimating equations (GEE) or linear mixed-effects models (LMM).","The study population comprises critically ill adult patients admitted to the intensive care units (ICUs) at the Second Affiliated Hospital of Hainan Medical University. Eligible participants are those diagnosed with sepsis-associated acute respiratory distress syndrome (ARDS) who require invasive mechanical ventilation and have confirmed hypoalbuminemia (serum albumin ≤ 30 g\u002FL). The prospective cohort is identified consecutively from active ICU admissions, while the historical control cohort is identified retrospectively from electronic medical records of patients admitted prior to the routine implementation of the targeted albumin protocol.",[35,38],{"label":36,"type":28,"description":37,"interventionNames":28},"Prospective Observational Cohort","Patients enrolled prospectively receiving current usual clinical care, which includes a targeted human albumin treatment strategy (aiming to maintain serum albumin ≥ 30 g\u002FL) combined with protocolized fluid de-resuscitation. Treatment decisions remain entirely under the discretion of the treating clinical team.",{"label":39,"type":28,"description":40,"interventionNames":28},"Historical Control Cohort","Patients identified retrospectively from electronic medical records who received usual clinical care (primarily crystalloid-based fluid management without a targeted albumin protocol) prior to the routine implementation of the targeted albumin strategy.",[42],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},"Fengyun Wang, MD\u002FPhD","CONTACT","8619389918115","dr-w@qq.com",[48],{"facility":5,"status":28,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"Haikou","Hainan","570003","China","CN",{"type":55,"coordinates":56},"Point",[57,58],110.34651,20.03421,{"lat":58,"lon":57},[61],{"name":43,"role":44,"phone":45,"phoneExt":28,"email":46},{"type":63,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100659017","effect-of-albumin-therapy-in-mechanically-ventilated-patients-with-sepsis-associated-ards-100659017",false,"NCT07857928","Effect of Albumin Therapy in Mechanically Ventilated Patients With Sepsis-Associated ARDS","A Prospective Observational Study With Historical Controls Evaluating Human Albumin Therapy in Mechanically Ventilated Patients With Sepsis-Associated Acute Respiratory Distress Syndrome","ALB-SARDS","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Clinical diagnosis conforming to the Sepsis-3 consensus criteria.\n* Diagnosis of acute respiratory distress syndrome (ARDS) fulfilling the European Society of Intensive Care Medicine (ESICM) criteria (mild, moderate, or severe).\n* Receiving invasive mechanical ventilation, with an intubation duration ≤ 48 hours at study enrollment.\n* First admission to the intensive care unit (ICU) ≤ 24 hours prior to enrollment.\n* Baseline serum albumin concentration ≤ 30 g\u002FL measured at hospital or ICU admission.\n* Anticipated ICU stay of \\> 48 hours.\n\nExclusion Criteria:\n\n* Female patients who are pregnant or lactating.\n* Severe burn injury or currently receiving extracorporeal membrane oxygenation (ECMO) support.\n* Perioperative period of liver transplantation or decompensated liver cirrhosis (Child-Pugh class C).\n* End-stage malignancy or an estimated clinical life expectancy \\\u003C 3 months.\n* Signed Do-Not-Resuscitate (DNR) order, agreement to withhold\u002Fwithdraw active life-sustaining therapy, or moribund state expected to result in death within 24 hours.\n* Known history of severe hypersensitivity or anaphylactic shock to human serum albumin preparations.","ALL","18 Years","85 Years",{"count":76,"type":77},260,"ESTIMATED","OBSERVATIONAL","Sepsis-associated acute respiratory distress syndrome (ARDS) is a serious condition where severe infection causes fluid accumulation in the lungs, often requiring invasive mechanical ventilation. Patients with low blood albumin levels are particularly vulnerable to this fluid leakage, leading to prolonged dependence on a ventilator.\n\nThis observational study evaluates the association between a targeted human albumin treatment strategy combined with clinically guided fluid removal, and clinical outcomes in adults with sepsis-associated ARDS and low blood albumin levels (≤ 30 g\u002FL).\n\nConducted at a single hospital, this study compares two groups. The prospective group consists of patients receiving current usual clinical care, where albumin administration and fluid management are determined by the treating clinical team. Their outcomes will be compared to a historical control group of similar patients who received standard care before this targeted albumin management strategy was routinely implemented.\n\nThe primary objective is to evaluate whether this targeted albumin strategy is associated with an increase in Ventilator-Free Days at day 28 (VFD-28). VFD-28 reflects both patient survival and successful liberation from the ventilator. The study will also observe secondary outcomes including oxygenation improvement, fluid balance, organ function, mortality, and safety events (e.g., fluid overload or allergic reactions). As an observational study, researchers do not assign treatments; all interventions are based on real-world clinical judgment.",[81,82,83],"Acute Respiratory Distress Syndrome","Sepsis","Hypoalbuminemia",[85,86,87,88,89],"Human Serum Albumin","Mechanical Ventilation","Fluid Management","De-resuscitation","Ventilator-Free Days","NOT_YET_RECRUITING","2026-09-29",{"date":93,"type":94},"2026-10-05","ACTUAL",{"date":96,"type":77},"2026-10-10",{"date":98,"type":77},"2027-12-31",{"name":5,"class":6},1]