Adjuvant intravenous immunoglobulin in elderly sepsis: a randomized controlled study of mortality, organ function,...

Sepsis carries high mortality in older people, and immunomodulatory adjuncts to standard therapy are needed. To evaluate the efficacy and safety of intravenous immunoglobulin (IVIG) as an adjunct to conventional treatment in elderly patients with sepsis.

In this single-center, prospective, open-label study with blinded outcome assessment, 120 elderly patients (≥65 years) meeting Sepsis-3 criteria were randomized to receive IVIG (0.4 g/kg/day for 3 days) plus conventional therapy (n = 60) or conventional therapy alone (n = 60). Primary outcomes were 28-day all-cause mortality and change in Sequential Organ Failure Assessment (SOFA) score. Secondary outcomes included inflammatory markers (C-reactive protein [CRP] and procalcitonin [PCT]), ICU length of stay, duration of mechanical ventilation, and adverse events.

Baseline characteristics were balanced. IVIG was associated with reduced 28-day mortality (18.3% vs. 31.7%; relative risk, 0.58; 95% CI, 0.31-0.97; p = 0.043). SOFA scores declined more rapidly in the IVIG group (mean reduction at day 7: 3.7 ± 1.2 vs. 2.1 ± 1.0 points; p < 0.001). CRP and PCT levels decreased more substantially with IVIG (55.6 ± 10.4 vs. 38.3 ± 9.7 mg/L, p < 0.001; and 5.3 ± 1.6 vs. 3.1 ± 1.4 ng/mL, p < 0.001). ICU stay (9.8 ± 2.7 vs. 12.4 ± 3.1 days, p = 0.024) and duration of mechanical ventilation (4.2 ± 1.1 vs. 5.7 ± 1.4 days, p = 0.011) were shorter in the IVIG group. Adverse events were infrequent and comparable between groups.

Adjunctive IVIG therapy in elderly sepsis patients was associated with lower 28-day mortality, accelerated recovery of organ function, reduced systemic inflammation, and decreased ICU resource utilization, with a favorable safety profile. These findings provide a direct link between immunomodulation and improved clinical outcomes in geriatric intensive care, supporting further evaluation of IVIG in larger multicenter studies targeting this high-risk population.