Evidence map›Paper›PMID 31797105›Full record

ArticleAnnals of intensive care2019

IgM-enriched immunoglobulins (Pentaglobin) may improve the microcirculation in sepsis: a pilot randomized trial.

Roberta Domizi, Erica Adrario, Elisa Damiani, Claudia Scorcella, Andrea Carsetti, Paolo Giaccaglia, Erika Casarotta, Vincenzo Gabbanelli, Simona Pantanetti, Elena Lamura and 2 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Annals of intensive care, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02655133 (Effects on Sublingual Microcirculation of IgGAM Immunoglobulins), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
2.7field-weighted citation impact, top 9% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT02655133 phase2completednot on this map

Effects on Sublingual Microcirculation of IgGAM Immunoglobulins (Pentaglobin®) in Severe Septic/Septic Shock Patients: a Randomized Controller Trial.

TypeinterventionalSponsorUniversità Politecnica delle MarcheRan2016 to 2018Enrolled20ConditionsSevere Sepsis, Septic ShockArmsPentaglobin®, Physiologic solution
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.

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  19. Use of Intravenous Immunoglobulins in Sepsis Therapy-A Clinical View.International journal of molecular sciences · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 2 institutions in 1 country.

Roberta DomiziAnesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, via Tronto 10/a, 60126, Torrette di Ancona, Italy.
Erica AdrarioAnesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, via Tronto 10/a, 60126, Torrette di Ancona, Italy.
Elisa DamianiAnesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, via Tronto 10/a, 60126, Torrette di Ancona, Italy.
Claudia ScorcellaAnesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, via Tronto 10/a, 60126, Torrette di Ancona, Italy.
Andrea CarsettiAnesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, via Tronto 10/a, 60126, Torrette di Ancona, Italy.
Paolo GiaccagliaAnesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, via Tronto 10/a, 60126, Torrette di Ancona, Italy.
Erika CasarottaAnesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, via Tronto 10/a, 60126, Torrette di Ancona, Italy.
Vincenzo GabbanelliAnesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, via Tronto 10/a, 60126, Torrette di Ancona, Italy.
Simona PantanettiAnesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, via Tronto 10/a, 60126, Torrette di Ancona, Italy.
Elena LamuraHospital Pharmacy, Azienda Ospedaliera Universitaria "Ospedali Riuniti Umberto I-Lancisi-Salesi" of Ancona, via Conca 71, 60126, Torrette di Ancona, Italy.
Silvia CiucaniAnesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, via Tronto 10/a, 60126, Torrette di Ancona, Italy.
Abele DonatiAnesthesia and Intensive Care Unit, Department of Biomedical Sciences and Public Health, Università Politecnica delle Marche, via Tronto 10/a, 60126, Torrette di Ancona, Italy. a.donati@univpm.it.ORCID http://orcid.org/0000-0001-6792-8741
Marche Polytechnic University · ITOspedali Riuniti Umberto I · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPolyclonal or IgM-enriched immunoglobulins may be beneficial during sepsis as an adjuvant immunomodulatory therapy. We aimed to test whether the infusion of IgM-enriched immunoglobulins improves microvascular perfusion during sepsis.

methodsSingle-centre, randomized, double-blind, placebo-controlled phase II trial including adult patients with a diagnosis of sepsis or septic shock for less than 24 h. Patients received an intravenous infusion of 250 mg/kg (5 mL/kg) per day of IgM-enriched immunoglobulins (Pentaglobin, n = 10) for 72 h or placebo (NaCl 0.9%, n = 9). At baseline and after 24 and 72 h of infusion, the sublingual microcirculation was assessed with Incident Dark Field videomicroscopy. Thenar near-infrared spectroscopy (NIRS) was applied with a vascular occlusion test to assess tissue oxygenation and microvascular reactivity. Levels of interleukin (IL) 1-beta, IL-6, IL-8, IL-10 and tumour necrosis factor alpha were measured in the serum.

resultsThe perfused vessel density (PVD) for small vessels (diameter < 20 micron) increased in the Pentaglobin group (from 21.7 ± 4.7 to 25.5 ± 5.1 mm/mm

conclusionsA 72-h infusion of IgM-enriched immunoglobulins (Pentaglobin) in patients with sepsis or septic shock may be associated with an increase in sublingual microvascular perfusion. Further studies are needed to confirm our findings. Trial registration NCT02655133, www.ClinicalTrials.gov, date of registration 7th January 2016, https://www.clinicaltrials.gov/ct2/show/NCT02655133.

Indexed as

ImmunoglobulinsImmunomodulationMicrocirculationPentaglobinSepsis

Identifiers

PMID31797105
PMCPMC6890901
OpenAlexW2991983879

What OpenQuestion holds

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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.