High-Dose Antithrombin III in Severe Sepsis

Warren, Brian; Eid, Alain; Singer, Pierre; Pillay, Subramanion S.; Carl, P; Novák, Ivan; Chalupa, Pavel; Atherstone, A; Pénzes, István; Kübler, Andrezej; Knaub, Sigurd; Keinecke, Heinz-Otto; Heinrichs, H.; Schindel, F.; Juers, Mathias; Bone, Roger C.; Opal, Steven M.

doi:10.1001/jama.286.15.1869

Cited by 1,248 publications

(313 citation statements)

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“…Guidelines for use in various countries do not recommend the use of antithrombin based on the results of a large‐scale clinical trial (the KyberSept trial) 390. In contrast, antithrombin replacement therapy is often used in patients with sepsis‐associated DIC in Japan.…”

Section: Cq16: Diagnosis and Treatment Of Disseminated Intravascular mentioning

confidence: 99%

“…However, there is currently no unified view regarding the efficacy of these drugs. One reason for this is that in the United States and European countries, the clinical utility of various anticoagulants has been studied primarily in large‐scale randomized controlled trials (RCTs) involving patients with severe sepsis 390, 391. These studies did not focus on sepsis‐associated DIC, and the anticoagulant therapies administered to the participants of these studies clearly differed from those used in Japan.…”

Section: Introductionmentioning

confidence: 99%

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The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG2016)

Nishida

Ogura

Egi

et al. 2018

Acute Medicine & Surgery

157

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Background and PurposeThe Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG 2016), a Japanese‐specific set of clinical practice guidelines for sepsis and septic shock created jointly by the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine, was first released in February 2017 in Japanese. An English‐language version of these guidelines was created based on the contents of the original Japanese‐language version.MethodsMembers of the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine were selected and organized into 19 committee members and 52 working group members. The guidelines were prepared in accordance with the Medical Information Network Distribution Service (Minds) creation procedures. The Academic Guidelines Promotion Team was organized to oversee and provide academic support to the respective activities allocated to each Guideline Creation Team. To improve quality assurance and workflow transparency, a mutual peer review system was established, and discussions within each team were open to the public. Public comments were collected once after the initial formulation of a clinical question (CQ), and twice during the review of the final draft. Recommendations were determined to have been adopted after obtaining support from a two‐thirds (>66.6%) majority vote of each of the 19 committee members.ResultsA total of 87 CQs were selected among 19 clinical areas, including pediatric topics and several other important areas not covered in the first edition of the Japanese guidelines (J‐SSCG 2012). The approval rate obtained through committee voting, in addition to ratings of the strengths of the recommendation and its supporting evidence were also added to each recommendation statement. We conducted meta‐analyses for 29 CQs. Thirty seven CQs contained recommendations in the form of an expert consensus due to insufficient evidence. No recommendations were provided for 5 CQs.ConclusionsBased on the evidence gathered, we were able to formulate Japanese‐specific clinical practice guidelines that are tailored to the Japanese context in a highly transparent manner. These guidelines can easily be used not only by specialists, but also by non‐specialists, general clinicians, nurses, pharmacists, clinical engineers, and other healthcare professionals.

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Section: Cq16: Diagnosis and Treatment Of Disseminated Intravascular mentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

The Japanese Clinical Practice Guidelines for Management of Sepsis and Septic Shock 2016 (J‐SSCG2016)

Nishida

Ogura

Egi

et al. 2018

Acute Medicine & Surgery

157

View full text Add to dashboard Cite

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“…However, in sepsis‐induced DIC, a decrease in AT activity is frequently observed27, 28, 29, 30 and is associated with high mortality rates 31, 32. Several RCTs to investigate the effects of high‐dose AT administration in patients with sepsis have been carried out 4, 33, 34, 35, 36. Although some RCTs indicated benefits of high‐dose AT administration in patients with sepsis,33, 34, 35 a large RCT (the KyberSept trial) failed to show any survival benefits 4.…”

Section: Antithrombinmentioning

confidence: 99%

“…Several RCTs to investigate the effects of high‐dose AT administration in patients with sepsis have been carried out 4, 33, 34, 35, 36. Although some RCTs indicated benefits of high‐dose AT administration in patients with sepsis,33, 34, 35 a large RCT (the KyberSept trial) failed to show any survival benefits 4. However, a subgroup analysis of the KyberSept trial indicated that AT administration significantly improved survival rates in patients with sepsis‐induced DIC 9…”

Section: Antithrombinmentioning

confidence: 99%

“…Over the past few decades, although some anticoagulant agents, such as antithrombin (AT), tissue factor pathway inhibitor, and activated protein C, have been investigated for use in patients by international large randomized controlled trials (RCTs), no remarkable effect on the mortality rate has been reported 4, 5, 6, 7. However, the post‐hoc subgroup analyses of those RCTs indicated that the anticoagulant therapies resulted in improved mortality rates in patients with sepsis‐induced DIC 8, 9.…”

Section: Introductionmentioning

confidence: 99%

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A summary of the Japan septic disseminated intravascular coagulation study

Hayakawa

Ono

2018

Acute Medicine & Surgery

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Over the past few decades, the large, international, randomized controlled trials of anticoagulant therapies for patients with sepsis have not yielded any improvement in mortality rates. However, in Japan, anticoagulant therapies are administered for sepsis patients with disseminated intravascular coagulation (DIC), but not for sepsis patients without DIC. Furthermore, epidemiological data regarding sepsis in Japan are scarce. Therefore, a nationwide multicenter retrospective observational study, the Japan Septic Disseminated Intravascular Coagulation (JSEPTIC DIC) study, was undertaken. The JSEPTIC DIC study enrolled 42 intensive care units and included 3,195 patients with sepsis. The results of the JSEPTIC DIC study indicated the following: (i) anticoagulant therapy may be effective in sepsis‐induced DIC patients at high risk for death, (ii) recombinant human soluble thrombomodulin administration and antithrombin supplementation are associated with survival benefits in patients with sepsis‐induced DIC.

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