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.
Aged 18 years or older.
Clinical diagnosis conforming to the Sepsis-3 consensus criteria.
Diagnosis of acute respiratory distress syndrome (ARDS) fulfilling the European Society of Intensive Care Medicine (ESICM) criteria (mild, moderate, or severe).
Receiving invasive mechanical ventilation, with an intubation duration ≤ 48 hours at study enrollment.
Female patients who are pregnant or lactating.
Severe burn injury or currently receiving extracorporeal membrane oxygenation (ECMO) support.
Perioperative period of liver transplantation or decompensated liver cirrhosis (Child-Pugh class C).
End-stage malignancy or an estimated clinical life expectancy < 3 months.
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/L). 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.
Cohort
Prospective
Not listed
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.
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.
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.
Change in Oxygenation Index (PaO2/FiO2 Ratio)
The daily worst PaO2/FiO2 ratio measured to evaluate the trajectory of lung function and pulmonary edema resolution.
28-Day All-Cause Mortality
The proportion of patients who die from any cause within the 28-day observation period.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
