IgM-enriched immunoglobulins (Pentaglobin) may improve the microcirculation in sepsis: a pilot randomized trial
| Autor: | Elisa Damiani, Paolo Giaccaglia, Erica Adrario, Erika Casarotta, Claudia Scorcella, Roberta Domizi, Simona Pantanetti, Elena Lamura, Vincenzo Gabbanelli, Abele Donati, Silvia Ciucani, Andrea Carsetti |
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| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Immunoglobulins Critical Care and Intensive Care Medicine Placebo Vascular occlusion Gastroenterology Microcirculation law.invention Immunomodulation Sepsis 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Internal medicine medicine 030212 general & internal medicine Septic shock business.industry Research lcsh:Medical emergencies. Critical care. Intensive care. First aid Pentaglobin Interleukin 030208 emergency & critical care medicine lcsh:RC86-88.9 medicine.disease Analysis of variance medicine.symptom business |
| Zdroj: | Annals of Intensive Care Annals of Intensive Care, Vol 9, Iss 1, Pp 1-13 (2019) |
| ISSN: | 2110-5820 |
| DOI: | 10.1186/s13613-019-0609-5 |
| Popis: | Background Polyclonal 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. Methods Single-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. Results The perfused vessel density (PVD) for small vessels (diameter 2) and decreased in the placebo group (from 25 ± 5.8 to 20.7 ± 4.1 mm/mm2, p for interaction p = 0.140. The microvascular flow index for small vessels increased at 24 h in the Pentaglobin group (from 2.68 [2.38–2.78] to 2.93 [2.82–3], p p Conclusions A 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. |
| Databáze: | OpenAIRE |
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