Trial reportCritical care (London, England)2013
Early treatment with IgM-enriched intravenous immunoglobulin does not mitigate critical illness polyneuropathy and/or myopathy in patients with multiple organ failure and SIRS/sepsis: a prospective, randomized, placebo-controlled, double-blinded trial.
Trial report in Critical care (London, England), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01867645 (The Impact of Early Treatment With IgM-enriched IVIG on Critical Illness Polyneuropathy and/or Myopathy in Patients With Multiple Organ Failure and SIRS/Sepsis), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Impact of Early Treatment With IgM-enriched IVIG on Critical Illness Polyneuropathy and/or Myopathy in Patients With Multiple Organ Failure and SIRS/Sepsis: A Prospective, Randomized, Placebo-controlled, Double-blinded Trial
Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 43 citations in OpenAlex.
- Interventions for preventing critical illness polyneuropathy and critical illness myopathy.The Cochrane database of systematic reviews · 2014Pooled it
- ICU-Acquired Weakness: An Unsolved Clinical Problem: A Narrative Review.Journal of clinical medicine · 2026Review
- Modes of (Inter)Actions of Polyvalent Immunoglobulins: Nonclinical and Clinical Research in Severe Bacterial Infections.Biomedicines · 2026Review
- Early detection and assessment of intensive care unit-acquired weakness: a comprehensive review.Acute and critical care · 2023Article
- High-dose intravenous immunoglobulins as a therapeutic option in critical illness polyneuropathy accompanying SARS-CoV-2 infection: A case-based review of the literature (Review).Experimental and therapeutic medicine · 2021Review
- Pathophysiology and management of critical illness polyneuropathy and myopathy.Journal of applied physiology (Bethesda, Md. : 1985) · 2021Article
- Best-practice IgM- and IgA-enriched immunoglobulin use in patients with sepsis.Annals of intensive care · 2020Review
- The clinical efficacy of intravenous IgM-enriched immunoglobulin (pentaglobin) in sepsis or septic shock: a meta-analysis with trial sequential analysis.Annals of intensive care · 2019Article
- IgM Augments Complement Bactericidal Activity with Serum from a Patient with a Novel CD79a Mutation.Journal of clinical immunology · 2018Article
- [Critical illness myopathy and polyneuropathy].Medizinische Klinik, Intensivmedizin und Notfallmedizin · 2017Review
- Review of Critical Illness Myopathy and Neuropathy.The Neurohospitalist · 2017Article
- Early prediction of intensive care unit-acquired weakness using easily available parameters: a prospective observational study.PloS one · 2014Observational
- Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionCritical illness polyneuropathy and/or myopathy (CIPNM) is a severe complication of critical illness. Retrospective data suggest that early application of IgM-enriched intravenous immunoglobulin (IVIG) may prevent or mitigate CIPNM. Therefore, the primary objective was to assess the effect of early IgM-enriched IVIG versus placebo to mitigate CIPNM in a prospective setting.
methodsIn this prospective, randomized, double-blinded and placebo-controlled trial, 38 critically ill patients with multiple organ failure (MOF), systemic inflammatory response syndrome (SIRS)/sepsis, and early clinical signs of CIPNM were included. Patients were randomly assigned to be treated either with IgM-enriched IVIG or placebo over a period of three days. CIPNM was measured by the CIPNM severity sum score based on electrophysiological stimulation of the median, ulnar, and tibial nerves on days 0, 4, 7, 14 and on the histological evaluation of muscle biopsies on days 0 and 14 and ranged from 0 (no CIPNM) to 8 (very severe CIPNM).
resultsA total of 38 critically ill patients were included and randomized to receive either IgM-enriched IVIG (n = 19) or placebo (n = 19). Baseline characteristics were similar between the two groups. CIPNM could not be improved by IVIG treatment, represented by similar CIPNM severity sum scores on day 14 (IVIG vs. placebo: 4.8 ± 2.0 vs. 4.5 ± 1.8; P = 0.70). CIPNM severity sum score significantly increased from baseline to day 14 (3.5 ± 1.6 vs. 4.6 ± 1.9; P = 0.002). After an interim analysis the study was terminated early due to futility in reaching the primary endpoint.
conclusionsEarly treatment with IVIG did not mitigate CIPNM in critically ill patients with MOF and SIRS/sepsis.
trial registrationClinicaltrials.gov: NCT01867645.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.