Effect of Albumin Therapy in Mechanically Ventilated Patients With Sepsis-Associated ARDS

Condition(s) studied

Study summary

Sepsis-associated acute respiratory distress syndrome (ARDS) is a severe 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.

Eligibility

Primary outcome measure(s)

• Ventilator-Free Days at Day 28 (VFD-28) — Up to 28 days from Time Zero (T0)
  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 — Up to 28 days from Time Zero (T0)
  Analyzed using a competing-risk model (treating death as a competing event) to evaluate the probability of successful weaning from invasive mechanical ventilation.

Trial sites (1)

More The Second Affiliated Hospital of Hainan Medical University trials in China

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