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 a ID pharmacist. Another face is an investor.

Enteral versus parenteral early nutrition in ventilated adults with shock: a randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2)

Lancetに発表された、ショックを伴う人口呼吸器管理の成人における早期の静脈栄養 vs 経腸栄養:ランダム化、制御、多施設、オープンラベル(NUTRIREA-2).

 

http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)32146-3/fulltext

 

 

Summary

Background

Whether the route of early feeding affects outcomes of patients with severe critical illnesses is controversial. We hypothesised that outcomes were better with early first-line enteral nutrition than with early first-line parenteral nutrition.

Methods

In this randomised, controlled, multicentre, open-label, parallel-group study (NUTRIREA-2 trial) done at 44 French intensive-care units (ICUs), adults (18 years or older) receiving invasive mechanical ventilation and vasopressor support for shock were randomly assigned (1:1) to either parenteral nutrition or enteral nutrition, both targeting normocaloric goals (20–25 kcal/kg per day), within 24 h after intubation. Randomisation was stratified by centre using permutation blocks of variable sizes. Given that route of nutrition cannot be masked, blinding of the physicians and nurses was not feasible. Patients receiving parenteral nutrition could be switched to enteral nutrition after at least 72 h in the event of shock resolution (no vasopressor support for 24 consecutive hours and arterial lactate <2 mmol/L). The primary endpoint was mortality on day 28 after randomisation in the intention-to-treat-population. This study is registered with ClinicalTrials.gov, number NCT01802099.

Findings

After the second interim analysis, the independent Data Safety and Monitoring Board deemed that completing patient enrolment was unlikely to significantly change the results of the trial and recommended stopping patient recruitment. Between March 22, 2013, and June 30, 2015, 2410 patients were enrolled and randomly assigned; 1202 to the enteral group and 1208 to the parenteral group. By day 28, 443 (37%) of 1202 patients in the enteral group and 422 (35%) of 1208 patients in the parenteral group had died (absolute difference estimate 2·0%; [95% CI −1·9 to 5·8]; p=0·33). Cumulative incidence of patients with ICU-acquired infections did not differ between the enteral group (173 [14%]) and the parenteral group (194 [16%]; hazard ratio [HR] 0·89 [95% CI 0·72–1·09]; p=0·25). Compared with the parenteral group, the enteral group had higher cumulative incidences of patients with vomiting (406 [34%] vs 246 [20%]; HR 1·89 [1·62–2·20]; p<0·0001), diarrhoea (432 [36%] vs 393 [33%]; 1·20 [1·05–1·37]; p=0·009), bowel ischaemia (19 [2%] vs five [<1%]; 3·84 [1·43–10·3]; p=0·007), and acute colonic pseudo-obstruction (11 [1%] vs three [<1%]; 3·7 [1·03–13·2; p=0·04).

Interpretation

In critically ill adults with shock, early isocaloric enteral nutrition did not reduce mortality or the risk of secondary infections but was associated with a greater risk of digestive complications compared with early isocaloric parenteral nutrition.

Funding

La Roche-sur-Yon Departmental Hospital and French Ministry of Health.

 

まずは、PECO

 

P : adults (18 years or older) receiving invasive mechanical ventilation and vasopressor support for shock

E : parenteral nutrition, targeting normocaloric goals (20–25 kcal/kg per day), within 24 h after intubation

C : enteral nutrition, targeting normocaloric goals (20–25 kcal/kg per day), within 24 h after intubation

O : The primary endpoint was mortality on day 28 

T : randomised, controlled, multicentre, open-label,  44 French intensive-care units (ICUs)

     ITT

 

結果

 

primary

 

By day 28, 443 (37%) of 1202 patients in the enteral group and 422 (35%) of 1208 patients in the parenteral group had died (absolute difference estimate 2·0%; [95% CI −1·9 to 5·8]; p=0·33).

 

Compared with the parenteral group, the enteral group had higher cumulative incidences of patients with vomiting (406 [34%] vs 246 [20%]; HR 1·89 [1·62–2·20]; p<0·0001),

diarrhoea (432 [36%] vs 393 [33%]; 1·20 [1·05–1·37]; p=0·009),

bowel ischaemia (19 [2%] vs five [<1%]; 3·84 [1·43–10·3]; p=0·007), 

acute colonic pseudo-obstruction (11 [1%] vs three [<1%]; 3·7 [1·03–13·2; p=0·04).

 

感想

 

面白い検討。

プライマリーはなんとか引き分けですが、副作用の側面から経腸はいまいちな結果。

でもでも、経腸は初期からハイカロリーでスタートしているし、そりゃ消化器症状出ますよね。嘔吐が両群に多いのも、なんだかフランスと日本の違いですかね。

 

 

ICU/CCUの薬の考え方、使い方 ver.2

ICU/CCUの薬の考え方、使い方 ver.2