IVIG therapy for the patients with hypogammaglobulinemia in sepsis -a multicenter randomized controlled trial-

Immunoglobulin therapy for sepsis with hypogammaglobulinemia -a multicenter randomized controlled trial- - Immunoglobulin therapy for sepsis with hypogammaglobulinemia

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000052620

Enrollment

300

Registered

2023-11-01

Start date

2024-12-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sepsis

Interventions

Single dose of IVIG 500 mg/kg Administer placebo (the same amount of saline as IVIG) without administering IVIG

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Sepsis or septic shock patients admitted to the intensive care unit with hypogammaglobulinemia (IgG<670 mg/dL)

Exclusion criteria

Exclusion criteria: Under 18 years old Congenital hypoammaglobulinemia or agammaglobulinemia Experienced cardiac arrest before randomization Received IVIG in the 30 days before randomization End-stage liver failure After organ transplant Expressed their intention to restrict treatment in some way by themselves or their legal guardian Expressed their intention to refuse participation in this study Any other information that the research representative (responsible person) or co-partner deems inappropriate to participate in the research.

Design outcomes

Primary

Measure	Time frame
Rate of death or organ failure 14 days after allocation	—

Countries

Japan

Contacts

Public ContactMasayuki Akatsuka

Sapporo Medical University School of Medicine Department of Intensive Care Medicine

m.akatsuka@sapmed.ac.jp011-611-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026