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Life sciences · Observational Study
ClinicalTrials.gov · October 5, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07857928). This is a study registration, not published results. Lead sponsor: The Second Affiliated Hospital of Hainan Medical University. Recruitment status: NOT_YET_RECRUITING. Study type: OBSERVATIONAL. Enrollment: 260 participants (ESTIMATED). Conditions: Acute Respiratory Distress Syndrome, Sepsis, Hypoalbuminemia. Primary outcome measures: Ventilator-Free Days at Day 28 (VFD-28) , Up to 28 days from Time Zero (T0); Cumulative Incidence of Successful Liberation from Ventilation , Up to 28 days from Time Zero (T0). Brief summary: 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. This 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/L). Conducted 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. The 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.