さまよう薬剤師のブログ

学位を持っても、センスのない、感染制御専門薬剤師のブログ.  I have Ph.D. but less sense ID pharmacist.

Continuous infusion of beta-lactam antibiotics in severe sepsis: a multicenter double-blind, randomized controlled trial.

Continuous infusion of beta-lactam antibiotics in severe sepsis: a multicenter double-blind, randomized controlled trial.

www.ncbi.nlm.nih.gov

 

2013年 CID に報告された、オーストラリアと香港の5施設ICUによる重症sepsisに対しするベータラクタム系のcontinuous infusion vs intermittent bolusのRCT。

 

 

 

PECO

 

P : patients with severe sepsis

E : continuous infusion

      n=30

C : intermittent bolus

      n=30

O : 

Plasma antibiotic concentrations exceeded the MIC in 82% of patients (18 of 22) in the continuous arm versus 29% (6 of 21) in the intermittent arm (P = .001).

Clinical cure was higher in the continuous group (70% vs 43%; P = .037),

but ICU-free days (19.5 vs 17 days; P = .14) did not significantly differ between groups.

Survival to hospital discharge was 90% in the continuous group versus 80% in the intermittent group (P = .47).

T :  prospective, double-blind, randomized controlled trial

 

Fig and Tab

Fig 1. CONSORT flow diagram.

f:id:akinohanayuki:20170610045612p:plain

 

Fig 2. Free plasma antibiotic concentration between treatment groups on the first sample.

f:id:akinohanayuki:20170610045626p:plain

Fig 3. Free plasma antibiotic concentration to minimum inhibitory concentration ratio for 3 samples.

f:id:akinohanayuki:20170610045739p:plain

 

Fig 4. Survival curve for patients in both treatment groups (data has been censored for patients discharged from hospital).

 

f:id:akinohanayuki:20170610045748p:plain

 

f:id:akinohanayuki:20170610045801p:plain

 

f:id:akinohanayuki:20170610045815p:plain

f:id:akinohanayuki:20170610045828p:plain

f:id:akinohanayuki:20170610045840p:plain

limitations

 

This study has a number of limitations.

 

Despite treatment groups being largely well balanced, differences existed for some baseline characteristics, such as 6 years younger mean age, 13% more males, 13% higher comorbidity and a 13% higher proportion of pre-ICU infections in the intervention group. A modest sample size in each group may have similarly resulted in potential confounding by unmeasured variables.

 

In terms of plasma antibiotic concentrations, only trough concentrations were measured. Therefore concentrations at 40-70% T>MIC could only be inferred to be greater than the MIC. A limited number of extreme concentration values in the intermittent group suggested the presence of some sample timing error.

 

感想

貴重なRCT。臨床反応は良好な傾向ですが、予後は微妙そうな結果。

絶対にCIという選択にはならないでしょう。

 

TAM関連のみでハードアウトカム改善は難しい印象。

 

個人的にCIは興味あるので、watchしてます。

 

関連記事

 

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akinohanayuki.hatenablog.com