The effect of early intravenous amino acid supplementation in critically ill patients without acute kidney injury: Protocol for a multicentre, randomised, parallel-controlled trial (the ESSENTIAL trial).

OBJECTIVE

There is uncertainty about whether early infusion of intravenous amino acids confers clinical benefits in critically ill patients. In this study, we aimed to test the hypothesis that intravenous amino acids could improve 90-day mortality in critically ill patients with normal kidney function.

DESIGN

This is a multicentre, open-label, randomised, parallel-controlled trial.

SETTING

20 ICUs across China.

PARTICIPANTS

1928 eligible critically ill patients with normal kidney function.

INTERVENTIONS

In addition to standard care, patients assigned to the intervention group will receive a continuous infusion of amino acids at a rate to achieve a total daily protein intake of approximately 2.0 g/kg/day.

MAIN OUTCOME MEASURES

The primary endpoint is all-cause mortality at day 90 after randomisation. Secondary endpoints and process measures will also be reported. The primary conclusions will be based on a modified intention-to-treat analysis for efficacy.

ETHICS AND DISSEMINATION

This study was approved by the ethics committee of the Jinling Hospital, Nanjing University (2020-NZKY-014-02 for the original version and 2020-NZKY-014-06 for the revised version) and all the participating sites. Results will be disseminated through journal publications and conference presentations.

REGISTRATION

This study protocol was registered with the Chinese Clinical Trial Registry, and the identifier is ChiCTR2100053359 (https://www.chictr.org.cn/hvshowprojectEN.html?id=257327&v=1.7).