High versus gradually increasing energy nutrition in the early phase of acute pancreatitis (GOULASH): a multicentre double-blind randomised clinical trial.

Nutritional support has been proven to improve outcome, but little is known regarding optimal timing and composition.

营养支持已被证明可以改善结果，但关于最佳时机和组成知之甚少。

This clinical trial aimed to compare high (30 kcal/kg/day, high energy (HE)) versus gradually increasing energy (0 increased to 30 kcal/kg/day over 4 days, low energy (LE)) strategies for enteral nutritional support in AP.

该临床试验旨在比较高能量（30 kcal/kg/天，高能量（HE））与逐渐增加能量（0增加至30 kcal/kg/天，持续4天，低能量（LE））策略在急性胰腺炎（AP）患者肠内营养支持中的效果。

Methods

This was a multicentric, double-blind, randomised clinical trial, enrolling patients with AP regardless of predicted severity (January 2017 to April 2023).

这是一项多中心、双盲、随机临床试验，招募了预测严重程度不同的急性胰腺炎（AP）患者（2017年1月至2023年4月）。

The primary outcome was a combination of mortality and severe acute pancreatitis (Revised Atlanta Criteria); secondary outcomes included severity, rate of infection, organ failure and pain relapse.

主要结果是死亡率和严重急性胰腺炎（修订版亚特兰大标准）的结合；次要结果包括严重程度、感染率、器官衰竭和疼痛复发。

Interim analysis was planned after 50% enrolment.

计划在招募50%的受试者后进行中期分析。

The Benjamini-Hochberg false discovery rate (FDR) method was used to correct p value for multiple testing.

使用了Benjamini-Hochberg假发现率（FDR）方法来校正多重检验的p值。

Results

The trial was stopped early after enrolling 636 patients.

在招募了636名患者后，试验提前终止。

Interim analysis showed that the primary outcome showed no difference between groups in the modified intention-to-treat(mITT) population (HE: 28/312, 9.0% vs LE: 18/307, 5.7%, p(uncorrected/corrected)=0.19/0.42).

中期分析显示，在修改后的意向治疗(mITT)人群中，主要结果在两组间无差异(HE组: 28/312, 9.0% vs LE组: 18/307, 5.7%, p(未校正/校正)=0.19/0.42)。

Secondary outcomes showed no difference in the mITT analysis.

次要结果在mITT分析中显示无差异。

Without correction for multiplicity testing, results favoured a low gradual energy strategy in terms of organ failure (HE: 52/312, 16.7% vs LE: 28/307, 9.1%, p(uncorrected)=0.007) and pain relapse (80/312, 27.1% vs 54/307, 19.0% p(uncorrected)=0.03) but showed no differences between groups after correction for multiple testing (p=0.13 and p=0.23, respectively).

在未进行多重性检验校正的情况下，低渐进能量策略在器官衰竭（HE: 52/312, 16.7% vs LE: 28/307, 9.1%, p(未校正)=0.007）和疼痛复发（80/312, 27.1% vs 54/307, 19.0% p(未校正)=0.03）方面显示出优势，但在进行多重检验校正后，两组之间没有差异（p=0.13和p=0.23，分别）。

It was determined that the superiority of the intervention would not be shown even with an increased sample size, and thus the trial was terminated based on a post hoc decision on ethics and futility.

经过确定，即使增加样本量，干预措施的优势也无法显示，因此基于事后对伦理和无效性的决定，试验被终止。

Conclusions

Based on this early terminated trial, a high-energy strategy for early nutrition in pancreatitis does not decrease mortality/severity, but potentially increases organ failure and pain relapse rate.

基于这项提前终止的试验，早期高能量营养策略在胰腺炎中并未降低死亡率/病情严重程度，但可能会增加器官衰竭和疼痛复发率。

trial_registration_number

ISRCTN63827758.

ISRCTN63827758。