The effect of higher protein dosing in critically ill patients with high nutritional risk (EFFORT Protein): an international, multicentre, pragmatic, registry-based randomised trial
An erratum to this article was published (Lancet, 25 Mar 2023 ↗)
Primary result · Cumulative incidence of alive hospital dischargeResult — go to the resultHazard ratio 0.91 95% CI 0.77–1.07Authors' conclusion
Delivery of higher doses of protein to mechanically ventilated critically ill patients did not improve the time-to-discharge-alive from hospital and might have worsened outcomes for patients with acute kidney injury and high organ failure scores.
Study context
- Population
- Nutritionally high-risk adults (≥18 years) undergoing mechanical ventilation in 85 intensive care units (ICUs) across 16 countries1,301 analysed
- Participants
- 1,329 adults
- Comparison
- High-dose protein vs usual dose protein
- High-dose proteinn = 645
- Usual dose proteinn = 656reference
- Primary endpoint
- Time-to-discharge-alive from hospital
- Follow-up
- Up to 60 days after ICU admission
Methodological detailsinternational, investigator-initiated, pragmatic, registry-based, single-blinded, multicentre, Jan 17, 2018 to Dec 3, 2021
- International
- Investigator-initiated
- Pragmatic
- Registry-based
- Single-blinded
- Multicentre
- Jan 17, 2018 to Dec 3, 2021
Primary result
Cumulative incidence of alive hospital discharge · 60 days after randomisation
Hazard ratio
0.91
95% CI 0.77–1.07
P = 0.27
By group
High-dose protein vs Usual dose protein
HR 0.91 (95% CI 0.77–1.07); P = 0.27
As reported in the abstract
Secondary outcomes
| Outcome | High-dose protein | Usual dose protein | RR (95% CI) | |
|---|---|---|---|---|
| 60-day mortality · up to 60 days | 34.6% | 32.1% | 1.08 (0.92–1.26) | |
| 0.512Relative risk (log scale) |
- 60-day mortality: 222 of 642 vs 208 of 648
Subgroups: AKI and higher organ failure scores at baseline (subgroup)
- Apparent subgroup effect: higher protein particularly harmful in patients with AKI and higher organ failure scores at baseline
Original publication
The effect of higher protein dosing in critically ill patients with high nutritional risk (EFFORT Protein): an international, multicentre, pragmatic, registry-based randomised trial. Lancet. Published 25 January 2023. doi:10.
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