Meta-analysis and trial sequential analysis of randomized controlled trials comparing aggressive versus non-aggressive intravenous fluid therapy in acute pancreatitis: an insight into the existence of type 2 error

IF 3.7 3区医学 Q2 GASTROENTEROLOGY & HEPATOLOGY

Journal of Gastroenterology and Hepatology Pub Date : 2024-06-13 DOI:10.1111/jgh.16648

Daisy Evans, Shahin Hajibandeh, Shahab Hajibandeh, Tejinderjit S Athwal, Thomas Satyadas

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引用次数: 0

Abstract

Background and Aim

We aimed to evaluate comparative outcomes of aggressive versus non-aggressive intravenous fluid (IVF) therapy in patients with acute pancreatitis.

Methods

A systematic search of electronic data sources and bibliographic reference lists were conducted. All randomized controlled trials (RCTs) reporting outcomes of aggressive versus non-aggressive IVF therapy in acute pancreatitis were included and their risk of bias were assessed. Effect sizes were determined for overall mortality, systemic inflammatory response syndrome (SIRS), sepsis, respiratory failure, pancreatic necrosis, severe pancreatitis, clinical improvement, AKI, and length of stay using random-effects modeling. Trial sequential analysis was conducted to determine risk of types 1 or 2 errors.

Results

We included 10 RCTs reporting 993 patients with acute pancreatitis who received aggressive (n = 475) or non-aggressive (n = 518) IVF therapy. Aggressive IVF therapy was associated with significantly higher rate of sepsis (OR: 2.68, P = 0.0005) and longer length of stay (MD: 0.94, P < 0.00001) compared with the non-aggressive approach. There was no statistically significant difference in mortality (RD: 0.02, P = 0.31), SIRS (OR: 0.93, P = 0.89), respiratory failure (OR: 2.81, P = 0.07), pancreatic necrosis (OR: 1.98, P = 0.06), severe pancreatitis (OR: 1.31, P = 0.38), clinical improvement (OR: 1.12, P = 0.83) or AKI (OR: 1.06, P = 0.91) between the two groups. Sub-group analysis demonstrated higher morbidity and mortality associated with the aggressive approach in more severe disease. Trial sequential analysis detected risk of type 2 error.

Conclusions

Aggressive IVF therapy may be associated with higher morbidity in patients with acute pancreatitis compared with the non-aggressive approach, particularly in patients with more severe disease. It may also prolong length of hospital stay. The available evidence is subject to type 2 error indicating the need for adequately powered RCTs.

查看原文本刊更多论文

比较急性胰腺炎积极静脉输液疗法与非积极静脉输液疗法的随机对照试验的 Meta 分析和试验序列分析：洞察 2 型误差的存在。

背景和目的：我们旨在评估急性胰腺炎患者积极静脉输液（IVF）疗法与非积极静脉输液疗法的疗效比较：我们对电子数据源和参考文献目录进行了系统检索。方法：对电子数据源和参考文献列表进行了系统搜索，纳入了所有报告急性胰腺炎患者积极静脉输液疗法与非积极静脉输液疗法疗效的随机对照试验（RCT），并对其偏倚风险进行了评估。采用随机效应模型确定了总死亡率、全身炎症反应综合征（SIRS）、脓毒症、呼吸衰竭、胰腺坏死、重症胰腺炎、临床改善、AKI 和住院时间的效应大小。进行了试验序列分析，以确定出现 1 类或 2 类错误的风险：我们纳入了10项RCT研究，这些研究报告了993名急性胰腺炎患者，他们接受了侵袭性（n = 475）或非侵袭性（n = 518）IVF疗法。积极的 IVF 治疗与较高的脓毒症发生率（OR：2.68，P = 0.0005）和较长的住院时间（MD：0.94，P 结论：积极的 IVF 治疗可能与较高的脓毒症发生率（OR：2.68，P = 0.0005）和较长的住院时间有关：与非激进疗法相比，激进的 IVF 疗法可能会导致急性胰腺炎患者的发病率升高，尤其是病情较重的患者。它还可能延长住院时间。现有证据存在2型误差，这表明需要进行有充分证据支持的RCT研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Gastroenterology and Hepatology 医学-胃肠肝病学

CiteScore

7.90

自引率

2.40%

发文量

326

审稿时长

2.3 months

期刊介绍： Journal of Gastroenterology and Hepatology is produced 12 times per year and publishes peer-reviewed original papers, reviews and editorials concerned with clinical practice and research in the fields of hepatology, gastroenterology and endoscopy. Papers cover the medical, radiological, pathological, biochemical, physiological and historical aspects of the subject areas. All submitted papers are reviewed by at least two referees expert in the field of the submitted paper.