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Crit Care. 2017 Jul 13;21(1):181. doi: 10.1186/s13054-017-1764-4.

Low-dose immunoglobulin G is not associated with mortality in patients with sepsis and septic shock.

Author information

1
Department of Anesthesiology and Critical Care Medicine, Jichi Medical University Saitama Medical Center, 1-847 Amanuma, Omiya, Saitatama, Saitama, 330-8503, Japan.
2
Department of Critical Care, Shonan Kamakura General Hospital, Kamakura, Japan.
3
Department of Anesthesiology and Critical Care Medicine, Jichi Medical University Saitama Medical Center, 1-847 Amanuma, Omiya, Saitatama, Saitama, 330-8503, Japan. msanui@mac.com.
4
Department of Clinical Epidemiology and Health Economics, School of Public Health, University of Tokyo, Tokyo, Japan.
5
Department of Surgery, Jichi Medical University, Tochigi, Japan.
6
Emergency and Critical Care Center, Hokkaido University Hospital, Sapporo, Japan.
7
Intensive Care Unit, Department of Anesthesiology, Jikei University School of Medicine, Tokyo, Japan.
8
Division of Trauma and Surgical Critical Care, Osaka General Medical Center, Osaka, Japan.
9
Division of Emergency and Critical Care Medicine, Tohoku University Graduate School of Medicine, Sendai, Japan.
10
Department of Anesthesiology and Intensive Care Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
11
Department of Intensive Care Medicine, Kameda Medical Center, Kamogawa, Japan.
12
Department of Emergency Medicine, University of Occupational and Environmental Health, Kita-Kyushu, Japan.
13
Division of Emergency and Critical Care Medicine, Department of Acute Medicine, Nihon University School of Medicine, Tokyo, Japan.
14
Department of Emergency and Critical Care Medicine, Ohta General Hospital Foundation, Ohta Nishinouchi Hospital, Koriyama, Japan.
15
Pharmaceutical Department, JA Hiroshima General Hospital, Hiroshima, Japan.
16
Department of Emergency and Critical Care Medicine, Saitama Red Cross Hospital, Saitama, Japan.
17
Department of Emergency and Critical Care Medicine, Wakayama Medical University, Wakayama, Japan.
18
Department of Emergency Medicine and Critical Care Medicine, Advanced Medical Emergency Department and Critical Care Center, Japan Red Cross Maebashi Hospital, Maebashi, Japan.
19
Emergency and Critical Care Center, Kyushu University Hospital, Fukuoka, Japan.
20
Department of Emergency and Critical Care Medicine, Faculty of Medicine, Fukuoka University, Fukuoka, Japan.
21
Emergency Department, Ibaraki Prefectural Central Hospital, Kasama, Japan.
22
Division of Intensive Care, Nagasaki University Hospital, Nagasaki, Japan.
23
Department of Emergency and Critical Care Medicine, Tokyo Medical University, Hachioji Medical Center, Tokyo, Japan.
24
Department of Emergency and Critical Care Medicine, Kyoto Daiichi Red-Cross Hospital, Kyoto, Japan.
25
Intensive Care Unit, Saiseikai Yokohamasi Tobu Hospital, Yokohama, Japan.
26
Department of Emergency Medicine, Asahikawa Medical University, Asahikawa, Japan.
27
Shock and Trauma Center, Nippon Medical School Chiba Hokusoh Hospital, Inzai, Japan.
28
Emergency Medicine, Kameda Medical Center, Kamogawa, Japan.
29
Department of Traumatology and Acute Critical Medicine, Osaka University Graduate School of Medicine, Suita, Japan.
30
Emergency and Critical Care Medicine, Asahikawa Red Cross Hospital, Asahikawa, Japan.
31
Department of Emergency and Critical Care Medicine, Graduate School of Medicine, University of the Ryukyu, Nishihara, Japan.
32
Advanced Critical Care Center, Gifu University Hospital, Gifu, Japan.
33
Emergency and Critical Care Center, Saga University Hospital, Saga, Japan.
34
The Division of Cardiovascular Disease, Steel Memorial Muroran Hospital, Muroran, Japan.
35
Department of Emergency Medicine and Critical Care, Sapporo City General Hospital, Sapporo, Japan.
36
Division of Emergency Medicine, Ehime University Hospital, Toon, Japan.
37
Intensive Care Unit, Tomishiro Central Hospital, Tomishiro, Japan.
38
Department of Emergency Medicine, Akashi City Hospital, Akashi, Japan.
39
Department of Emergency and Critical Care, Sendai City Hospital, Sendai, Japan.
40
Emergency Department, Hakodate Municipal Hospital, Hakodate, Japan.
41
Emergency and Critical Care Center, Mie University Hospital, Tsu, Japan.
42
Department of Emergency Medicine, Gunma University, Maebashi, Japan.
43
Department of Anesthesia and Intensive Care, KKR Sapporo Medical Center, Sapporo, Japan.
44
Emergency and Critical Care Center, Seirei Mikatahara General Hospital, Hamamatsu, Japan.
45
Intensive Care Unit, Hyogo College of Medicine, Nishinomiya, Japan.

Abstract

BACKGROUND:

The administration of low-dose intravenous immunoglobulin G (IVIgG) (5 g/day for 3 days; approximate total 0.3 g/kg) is widely used as an adjunctive treatment for patients with sepsis in Japan, but its efficacy in the reduction of mortality has not been evaluated. We investigated whether the administration of low-dose IVIgG is associated with clinically important outcomes including intensive care unit (ICU) and in-hospital mortality.

METHODS:

This is a post-hoc subgroup analysis of data from a retrospective cohort study, the Japan Septic Disseminated Intravascular Coagulation (JSEPTIC DIC) study. The JSEPTIC DIC study was conducted in 42 ICUs in 40 institutions throughout Japan, and it investigated associations between sepsis-related coagulopathy, anticoagulation therapies, and clinical outcomes of 3195 adult patients with sepsis and septic shock admitted to ICUs from January 2011 through December 2013. To investigate associations between low-dose IVIgG administration and mortalities, propensity score-based matching analysis was used.

RESULTS:

IVIgG was administered to 960 patients (30.8%). Patients who received IVIgG were more severely ill than those who did not (Acute Physiology and Chronic Health Evaluation (APACHE) II score 24.2 ± 8.8 vs 22.6 ± 8.7, p < 0.001). They had higher ICU mortality (22.8% vs 17.4%, p < 0.001), but similar in-hospital mortality (34.4% vs 31.0%, p = 0.066). In propensity score-matched analysis, 653 pairs were created. Both ICU mortality and in-hospital mortality were similar between the two groups (21.0% vs 18.1%, p = 0.185, and 32.9% vs 28.6%, p = 0.093, respectively) using generalized estimating equations fitted with logistic regression models adjusted for other therapeutic interventions. The administration of IVIgG was not associated with ICU or in-hospital mortality (odds ratio (OR) 0.883; 95% confidence interval (CI) 0.655-1.192, p = 0.417, and OR 0.957, 95% CI, 0.724-1.265, p = 0.758, respectively).

CONCLUSIONS:

In this analysis of a large cohort of patients with sepsis and septic shock, the administration of low-dose IVIgG as an adjunctive therapy was not associated with a decrease in ICU or in-hospital mortality.

TRIAL REGISTRATION:

University Hospital Medical Information Network Individual Clinical Trials Registry, UMIN-CTR000012543 . Registered on 10 December 2013.

KEYWORDS:

Adjunctive therapy; IVIG; Infection; Polyclonal intravenous immunoglobulin G; Propensity score; Sepsis

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