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Published in: Critical Care 1/2017

Open Access 01-12-2017 | Research

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

Authors: Yusuke Iizuka, Masamitsu Sanui, Yusuke Sasabuchi, Alan Kawarai Lefor, Mineji Hayakawa, Shinjiro Saito, Shigehiko Uchino, Kazuma Yamakawa, Daisuke Kudo, Kohei Takimoto, Toshihiko Mayumi, Takeo Azuhata, Fumihito Ito, Shodai Yoshihiro, Katsura Hayakawa, Tsuyoshi Nakashima, Takayuki Ogura, Eiichiro Noda, Yoshihiko Nakamura, Ryosuke Sekine, Yoshiaki Yoshikawa, Motohiro Sekino, Keiko Ueno, Yuko Okuda, Masayuki Watanabe, Akihito Tampo, Nobuyuki Saito, Yuya Kitai, Hiroki Takahashi, Iwao Kobayashi, Yutaka Kondo, Wataru Matsunaga, Sho Nachi, Toru Miike, Hiroshi Takahashi, Shuhei Takauji, Kensuke Umakoshi, Takafumi Todaka, Hiroshi Kodaira, Kohkichi Andoh, Takehiko Kasai, Yoshiaki Iwashita, Hideaki Arai, Masato Murata, Masahiro Yamane, Kazuhiro Shiga, Naoto Hori

Published in: Critical Care | Issue 1/2017

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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.
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Metadata
Title
Low-dose immunoglobulin G is not associated with mortality in patients with sepsis and septic shock
Authors
Yusuke Iizuka
Masamitsu Sanui
Yusuke Sasabuchi
Alan Kawarai Lefor
Mineji Hayakawa
Shinjiro Saito
Shigehiko Uchino
Kazuma Yamakawa
Daisuke Kudo
Kohei Takimoto
Toshihiko Mayumi
Takeo Azuhata
Fumihito Ito
Shodai Yoshihiro
Katsura Hayakawa
Tsuyoshi Nakashima
Takayuki Ogura
Eiichiro Noda
Yoshihiko Nakamura
Ryosuke Sekine
Yoshiaki Yoshikawa
Motohiro Sekino
Keiko Ueno
Yuko Okuda
Masayuki Watanabe
Akihito Tampo
Nobuyuki Saito
Yuya Kitai
Hiroki Takahashi
Iwao Kobayashi
Yutaka Kondo
Wataru Matsunaga
Sho Nachi
Toru Miike
Hiroshi Takahashi
Shuhei Takauji
Kensuke Umakoshi
Takafumi Todaka
Hiroshi Kodaira
Kohkichi Andoh
Takehiko Kasai
Yoshiaki Iwashita
Hideaki Arai
Masato Murata
Masahiro Yamane
Kazuhiro Shiga
Naoto Hori
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Critical Care / Issue 1/2017
Electronic ISSN: 1364-8535
DOI
https://doi.org/10.1186/s13054-017-1764-4

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