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Individualised nutritional support in medical inpatients at nutritional risk: a randomised clinical trial.

Schuetz P, et al. Lancet. 2019







フレイルティ、Functional Outcomes、および低栄養の入院患者の回復に対する早期の栄養サポートの効果試験(EFFORT)は、実用的な、研究者主導型で非盲検の多施設共同試験です。

本研究は、栄養学的リスク([NRS 2002]スコア≧3ポイント)で、スイスの8つの病院から4日以上の入院予定期間で医療患者を募集しました。これらの参加者は、タンパク質およびカロリー目標に到達するためのプロトコルアシスト個別栄養(介入群)または標準的な病院食(対照群)に無作為に割り当てられた(1:1)。研究サイトおよび低栄養の重症度に応じて、対話型Web応答システムを使用して、可変ブロックサイズおよび層別化を用いてランダム化を行った。



30日までに、介入群の232人(23%)の患者は、対照群の1013人の患者の272人(27%)と比較して、有害な臨床転帰を経験した(調整オッズ比[OR] 0.79[95%CI ]0.64−0.97]、p=0.023)。 30日目までに、対照群の100 [10%]患者と比較して73 [7%]の患者が介入群で死亡した(調整OR 0.65 [0.47-0.91]、p=0.011)。
介入群と対照群の間で栄養補給による副作用を経験した患者の割合に差はなかった(162 [16%]対145 [14%]、調整後OR 1.16 [0.90-1.51] ]、p= 0.26)。


スイス国立科学財団およびKantonsspital Aarau(スイス)の研究評議会。






Guidelines recommend the use of nutritional support during hospital stays for medical patients (patients not critically ill and not undergoing surgical procedures) at risk of malnutrition. However, the supporting evidence for this recommendation is insufficient, and there is growing concern about the possible negative effects of nutritional therapy during acute illness on recovery and clinical outcomes. Our aim was thus to test the hypothesis that protocol-guided individualised nutritional support to reach protein and caloric goals reduces the risk of adverse clinical outcomes in medical inpatients at nutritional risk.


The Effect of early nutritional support on Frailty, Functional Outcomes, and Recovery of malnourished medical inpatients Trial (EFFORT) is a pragmatic, investigator-initiated, open-label, multicentre study. We recruited medical patients at nutritional risk (nutritional risk screening 2002 [NRS 2002] score ≥3 points) and with an expected length of hospital stay of more than 4 days from eight Swiss hospitals. These participants were randomly assigned (1:1) to receive either protocol-guided individualised nutritional support to reach protein and caloric goals (intervention group) or standard hospital food (control group). Randomisation was done with variable block sizes and stratification according to study site and severity of malnutrition using an interactive web-response system. In the intervention group, individualised nutritional support goals were defined by specialist dietitians and nutritional support was initiated no later than 48 h after admission. Patients in the control group received no dietary consultation.
The composite primary endpoint was any adverse clinical outcome defined as all-cause mortality, admission to intensive care, non-elective hospital readmission, major complications, and decline in functional status at 30 days, and it was measured in all randomised patients who completed the trial. This trial is registered with ClinicalTrials.gov, number NCT02517476.


5015 patients were screened, and 2088 were recruited and monitored between April 1, 2014, and Feb 28, 2018. 1050 patients were assigned to the intervention group and 1038 to the control group. 60 patients withdrew consent during the course of the trial (35 in the intervention group and 25 in the control group). During the hospital stay, caloric goals were reached in 800 (79%) and protein goals in 770 (76%) of 1015 patients in the intervention group.
By 30 days, 232 (23%) patients in the intervention group experienced an adverse clinical outcome, compared with 272 (27%) of 1013 patients in the control group (adjusted odds ratio [OR] 0·79 [95% CI 0·64-0·97], p=0·023). By day 30, 73 [7%] patients had died in the intervention group compared with 100 [10%] patients in the control group (adjusted OR 0·65 [0·47-0·91], p=0·011).
There was no difference in the proportion of patients who experienced side-effects from nutritional support between the intervention and the control group (162 [16%] vs 145 [14%], adjusted OR 1·16 [0·90-1·51], p=0·26).


In medical inpatients at nutritional risk, the use of individualised nutritional support during the hospital stay improved important clinical outcomes, including survival, compared with standard hospital food. These findings strongly support the concept of systematically screening medical inpatients on hospital admission regarding nutritional risk, independent of their medical condition, followed by a nutritional assessment and introduction of individualised nutritional support in patients at risk.


The Swiss National Science Foundation and the Research Council of the Kantonsspital Aarau, Switzerland.