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

Domizi, Roberta; Adrario, Erica; Damiani, Elisa; Scorcella, Claudia; Carsetti, Andrea; Giaccaglia, Paolo; Casarotta, Erika; Gabbanelli, Vincenzo; Pantanetti, Simona; Lamura, Elena; Ciucani, Silvia; Donati, Abele

doi:10.1186/s13613-019-0609-5

Annals of Intensive Care

Table 2 Changes in sublingual microcirculation and NIRS-derived parameters

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

	Baseline	24 h	72 h	p (time)^a	p (interaction)^b
PVDs (mm/mm²)				0.869	< 0.001
Pentaglobin (n = 10)	21.7 ± 4.7	23.4 ± 6.0	25.5 ± 5.1*
Placebo (n = 9)	25.0 ± 5.8	23.8 ± 4.4	20.7 ± 4.1**
MFIs (AU)					–
Pentaglobin (n = 10)	2.68 [2.38–2.78]	2.93 [2.82–3.00]**	2.82 [2.65–2.95]	0.002
Placebo (n = 9)	2.83 [2.60–2.97]	2.93 [2.62–2.93]	2.67 [2.48–2.73]*	0.016
TVDs (mm/mm²)					–
Pentaglobin (n = 10)	25.5 [17.9–27.1]	24.9 [18.7–27.6]	27.0 [19.3–29.6]	0.436
Placebo (n = 9)	26.6 [21.1–30.3]	25.2 [20.5–28.1]	22.5 [17.8–26.6]	0.154
De Backer score (n/mm)				0.887	0.144
Pentaglobin (n = 10)	13.1 ± 2.2	13.3 ± 3.4	14.2 ± 2.7
Placebo (n = 9)	13.9 ± 2.8	13.2 ± 2.4	12.8 ± 2.7
PPVs (%)					–
Pentaglobin (n = 10)	96 [87–98]	99 [98–100]	98 [97–100]	0.050
Placebo (n = 9)	98 [96–99]	98 [97–99]	96 [94–98]^#	0.154
FHI (AU)					–
Pentaglobin (n = 10)	0.31 [0.16–0.45]	0.03 [0–0.13]	0.07 [0–0.18]	0.032
Placebo (n = 9)	0.18 [0.03–0.30]	0.07 [0.07–0.18]	0.11 [0.03–0.26]	0.495
StO₂ (%)					–
Pentaglobin (n = 10)	80 [79–84]	84 [79–89]	84 [77–88]	0.316
Placebo (n = 9)	85 [72–86]	81 [78–84]	84 [75–87]	0.658
StO₂ downslope (%/min)					–
Pentaglobin (n = 10)	− 8.4 [− 10.8, − 6.1]	− 10.9 [− 11.9, − 8.2]	− 11.5 [− 16.3, − 9.1]	0.367
Placebo (n = 9)	− 8.0 [− 14.2, − 5.7]	− 6.6 [− 13.9, − 6.1]	− 10.2 [− 12.3, − 6.7]	0.813
StO₂ upslope (%/min)				0.005	0.681
Pentaglobin (n = 10)	157 ± 37	224 ± 82**	207 ± 77
Placebo (n = 9)	120 ± 57	162 ± 68	146 ± 73
Area of hyperemia (%*min)				0.002	0.544
Pentaglobin (n = 10)	16.7 ± 10.5	12.7 ± 8.3	10.3 ± 5.9*
Placebo (n = 9)	15.3 ± 10.3	13.9 ± 7.4	7.1 ± 6.8*
THI (AU)					–
Pentaglobin (n = 10)	12 [9–15]	11 [8–12]	10 [8–14]	0.601
Placebo (n = 9)	11 [7–13]	10 [7–13]	8 [7–12]	0.654

Data are expressed as mean ± standard deviation or median [1st–3rd quartile], as appropriate
NIRS near-infrared spectroscopy, PVD perfused vessel density, MFI microvascular flow index, TVD total vessel density, PPV percentage of perfused vessels, FHI flow heterogeneity index, StO₂ tissue oxygen saturation, THI tissue haemoglobin index, AU arbitrary units
^aTwo-way analysis of variance for repeated measures (testing the effect of time) or Friedman test, as appropriate
^bTwo-way analysis of variance for repeated measures (testing for the interaction between time and treatment), when applicable
* p < 0.05, **p < 0.01 versus baseline, Two-way analysis of variance for repeated measures with Sidack’s post hoc test or Friedman test with Dunn’s post hoc test for multiple comparisons, as appropriate
^#p < 0.05 versus Pentaglobin group, Mann–Whitney U test

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