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The effects of Immunoglobulin M (IgM) enriched immunoglobulin preparations in patients with severe sepsis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN28863830
Enrollment
39
Registered
2002-04-29
Start date
2000-01-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Severe sepsis Infections and Infestations Sepsis

Interventions

Patients in the study group (n = 21) received intravenous immunoglobulin preparation (Pentaglobin®) in addition to standard therapy. Pentaglobin® was started on the day of diagnosis of severe sepsis.

Sponsors

Istanbul University (Turkey)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Thirty-nine patients with severe sepsis, defined as: 1. Temperature of greater than 38°C or less than 36°C 2. Heart rate of greater than 90 beats/min 3. Respiratory rate greater than 20/min or arterial carbon dioxide pressure (PaCO2) less than 32 mmHg 4. White blood cell count greater than 12000/mm^3 or less than 4000/mm^3 5. Documented infection and dysfunction of an organ or hypotension

Exclusion criteria

Exclusion criteria: Does not comply with above inclusion criteria

Design outcomes

Primary

MeasureTime frame
Procalcitonin (PCT) measurements; blood samples were taken daily for eight days following study admission.

Secondary

MeasureTime frame
1. Severity of critical illness, assessed by obtaining daily acute physiological and chronic health evaluation score (APACHE II) 2. Sequential organ failure assessment (SOFA) score used to assess the development of organ failure 3. Duration of mechanical ventilation 4. Length of stay in the intensive care unit 5. Septic shock incidence 6. 28-day mortality rate

Countries

Turkey

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 22, 2026