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The clinical efficacy of intravenous IgM-enriched immunoglobulin (pentaglobin) in sepsis or septic shock: a meta-analysis with trial sequential analysis

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Cui, Jie, Wei, Xuxia, Lv, Haijin, Li, Yuntao, Li, Ping, Chen, Zhen, Liu, Genglong·2019·Annals of Intensive Care
DOI 10.1186/s13613-019-0501-3PMC PMC6365591
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Abstract

BACKGROUND: Sepsis is characterized by a complex immune response. This meta-analysis evaluated the clinical effectiveness of intravenous IgM-enriched immunoglobulin (IVIgGM) in patients with sepsis and septic shock. METHODS: Four databases, PubMed, the Cochrane Library, the ISI Web of Knowledge, and Embase, were systematically searched from inception to June 2018 to update the 2013 edition of the Cochrane review by two investigators, who independently selected studies, extracted relevant data, and evaluated study quality. Data were subjected to a meta-analysis and trial sequential analysis (TSA) for the primary and secondary outcomes. Level of evidence was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) scale. RESULTS: = 0%). TSA showed that IVIgGM had a significant effect on mortality. Additionally, the meta-analysis suggested that use of IVIgGM shortened length of mechanical ventilation (mean difference - 3.16 days; 95% CI - 5.71 to - 0.61 days) and did not shorten length of stay in the intensive care unit (mean difference - 0.38 days; 95% CI - 3.55 to 2.80 days). The GRADE scale showed that the certainty of the body of evidence was low for both benefits and IVIgGM. CONCLUSION: Administration of IVIgGM to adult septic patients may be associated with reduced mortality. Treatment effects tended to be smaller or less consistent when including only those studies deemed adequate for each indicator. The available evidence is not clearly sufficient to support the widespread use of IVIgGM in the treatment of sepsis. Trial registration PROSPERO registration number: CRD42018084120. Registered on 11 February 2018.

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  • We identified one relevant RCT and two observational studies on intravascular device removal.

    “We identified one relevant RCT (274) and two observational studies (275, 276).”

    From Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. (2021) · cites this paper as [276]

    The Discussion (page unavailable) describes a meta-analysis of IgM-enriched immunoglobulin for sepsis, including 15 RCTs and four cohort studies. Searches for intravascular device or catheter removal found no passage identifying an RCT or two observational studies on that topic. The cited paper’s copy therefore does not substantiate the attributed identification. (LLM, conf=0.76)

    Experimental — accuracy not yet measured

  • There was no evidence of a difference in mortality with intravascular device removal, but the studies had significant limitations including risk of confounding by indication and imprecision.

    “There was no evidence of a difference in mortality, however, the studies were hampered by significant limitations, including risk of confounding by indication (the observational studies) and imprecision (the RCT), which is why the results should be interpreted cautiously.”

    From Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock 2021. (2021) · cites this paper as [276]

    The Discussion (page not provided) reports mortality findings for intravenous IgM-enriched immunoglobulin in sepsis, not for intravascular device removal. Searches for device or catheter removal and for confounding by indication found no passage addressing the attributed claim. (LLM, conf=0.78)

    Experimental — accuracy not yet measured

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Cited by

Sorted by citations

Authors
Cui, J., Wei, X., Lv, H., Li, Y., Li, P., Chen, Z., & Liu, G.
Affiliations
  • Guangzhou Medical University Cancer Hospital (CN)
  • Third Affiliated Hospital of Sun Yat-sen University (CN)
  • Guangdong Provincial Hospital of Chinese Medicine (CN)
  • Southern Medical University (CN)
Corresponding author
  • Chen, Zhen
  • Liu, Genglong
ORCID
Venue
Annals of Intensive Care
Publisher
Elsevier BV
Published
2019
Volume
9
Issue
1
Pages
27
ISSN
2110-5820 (ISSN-L)
DOI
10.1186/s13613-019-0501-3
PMC
PMC6365591
OpenAlex
W2917384272
Cited by
105
References
1
Citations by year
2026: 10 · 2025: 12 · 2024: 11 · 2023: 24 · 2022: 10 · 2021: 21 · 2020: 12 · 2019: 5
FWCI
1.75
Type
journal article
Language
en
Open access
Licence
Locations
  • Annals of Intensive Care (publishedVersion, cc-by)
  • Europe PMC (PubMed Central) (publishedVersion, other-oa)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
  • DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
Topics
  • Health Sciences › Medicine › Epidemiology › Sepsis Diagnosis and Treatment
  • Health Sciences › Medicine › Pharmacology › Antibiotics Pharmacokinetics and Efficacy
  • Life Sciences › Immunology and Microbiology › Microbiology › Bacterial Infections and Vaccines
Keywords
Pentaglobin, intravenous immunoglobulin, IgM-enriched immunoglobulin, sepsis, septic shock, mortality, mechanical ventilation duration, ICU length of stay, trial sequential analysis

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