Skip to main content
U.S. flag

An official website of the United States government

Official websites use .gov
A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS
A lock ( ) or https:// means you’ve safely connected to the .gov website. Share sensitive information only on official, secure websites.

Skip to content

The effects of IgM-enriched immunoglobulin preparations in patients with severe sepsis [ISRCTN28863830]

Metadata Updated: September 7, 2025

Introduction In this prospective, randomized controlled study, we aimed to evaluate the effect of IgM-enriched immunoglobulin treatment on progression of organ failure and septic shock in patients with severe sepsis.

      Materials and methods
      Forty-two patients with severe sepsis were enrolled in the study. Patients in the study group (n = 21) received an intravenous immunoglobulin preparation (Pentaglobin®) in addition to standard therapy. Pentaglobin® therapy was commenced on the day of diagnosis of severe sepsis: 5 ml/kg per day Pentaglobin® (38 g/l IgG, 6 g/l IgM, and 6 g/l IgA) was infused over 6 hours and repeated for 3 consecutive days. Patients in the control group (n = 18) received standard sepsis therapy, but no immunoglobulin administration. Blood samples for procalcitonin (PCT) measurements were taken daily for 8 days. Severity of critical illness and development of organ failure were assessed by obtaining daily acute physiological and chronic health evaluation (APACHE) II and sequential organ failure assessment (SOFA) scores.


      Results and discussion
      Procalcitonin levels showed a statistically significant decrease in the Pentaglobin® group (P < 0.001); however, an improvement in SOFA scores could not be demonstrated. Procalcitonin levels and SOFA scores did not change significantly in the control group. Septic shock incidence (38% versus 57%) and 28-day mortality rate (23.8% versus 33.3%) were found to be similar between the Pentaglobin® and control groups. The evaluation of serial APACHE II scores did not demonstrate a difference between Pentaglobin® and control groups either.


      Conclusion
      Present data could not demonstrate any beneficial effects of polyclonal immunoglobulin preparation Pentaglobin® on organ morbidity, septic shock incidence and mortality rate in patients with severe sepsis.

Access & Use Information

Public: This dataset is intended for public access and use. License: No license information was provided. If this work was prepared by an officer or employee of the United States government as part of that person's official duties it is considered a U.S. Government Work.

Downloads & Resources

Dates

Metadata Created Date July 24, 2025
Metadata Updated Date September 7, 2025

Metadata Source

Harvested from Healthdata.gov

Additional Metadata

Resource Type Dataset
Metadata Created Date July 24, 2025
Metadata Updated Date September 7, 2025
Publisher National Institutes of Health
Maintainer
NIH
Identifier https://healthdata.gov/api/views/q4d3-h5qt
Data First Published 2025-07-14
Data Last Modified 2025-09-06
Category NIH
Public Access Level public
Bureau Code 009:25
Metadata Context https://project-open-data.cio.gov/v1.1/schema/catalog.jsonld
Metadata Catalog ID https://healthdata.gov/data.json
Schema Version https://project-open-data.cio.gov/v1.1/schema
Catalog Describedby https://project-open-data.cio.gov/v1.1/schema/catalog.json
Harvest Object Id f6a86bcf-0329-40ea-b3c9-a3ec224805fc
Harvest Source Id 651e43b2-321c-4e4c-b86a-835cfc342cb0
Harvest Source Title Healthdata.gov
Homepage URL https://healthdata.gov/d/q4d3-h5qt
Program Code 009:032
Source Datajson Identifier True
Source Hash 09ef825bc88c4869377f8028f4c02638282edff724339d240598658cda4494e0
Source Schema Version 1.1

Didn't find what you're looking for? Suggest a dataset here.