Intensive glucose control in critically ill adults: a protocol for a systematic review and individual patient data meta-analysis.

Derick Adigbli, Li Yang, Naomi Hammond, Djillali Annane, Yaseen Arabi, Federico Bilotta, Julien Bohé, Frank Martin Brunkhorst, Alexandre Biasi Cavalcanti, Deborah Cook, Christoph Engel, Deborah Green-LaRoche, Wei He, William Henderson, Cornelia Hoedemaekers, Gaetano Iapichino, Pierre Kalfon, Gisela de La Rosa, Iain MacKenzie, Christian Mélot, Imogen Mitchell, Tuomas Oksanen, Federico Polli, Jean-Charles Preiser, Francisco Garcia Soriano, Ling-Cong Wang, Jiaxiang Yuan, Anthony Delaney, Gian Luca Di Tanna, Simon Finfer
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Abstract

Objective: The optimal target for blood glucose concentration in critically ill patients is unclear. We will perform a systematic review and meta-analysis with aggregated and individual patient data from randomized controlled trials, comparing intensive glucose control with liberal glucose control in critically ill adults.

Data sources: MEDLINE®, Embase, the Cochrane Central Register of Clinical Trials, and clinical trials registries (World Health Organization, clinical trials.gov). The authors of eligible trials will be invited to provide individual patient data. Published trial-level data from eligible trials that are not at high risk of bias will be included in an aggregated data meta-analysis if individual patient data are not available.

Methods: Inclusion criteria: randomized controlled trials that recruited adult patients, targeting a blood glucose of ≤ 120mg/dL (≤ 6.6mmol/L) compared to a higher blood glucose concentration target using intravenous insulin in both groups. Excluded studies: those with an upper limit blood glucose target in the intervention group of > 120mg/dL (> 6.6mmol/L), or where intensive glucose control was only performed in the intraoperative period, and those where loss to follow-up exceeded 10% by hospital discharge.

Primary endpoint: In-hospital mortality during index hospital admission. Secondary endpoints: mortality and survival at other timepoints, duration of invasive mechanical ventilation, vasoactive agents, and renal replacement therapy. A random effect Bayesian meta-analysis and hierarchical Bayesian models for individual patient data will be used.

Discussion: This systematic review with aggregate and individual patient data will address the clinical question, 'what is the best blood glucose target for critically ill patients overall?'Protocol version 0.4 - 06/26/2023PROSPERO registration:CRD42021278869.

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成人重症患者的强化血糖控制:系统综述和个体患者数据荟萃分析方案。
目的:重症患者血糖浓度的最佳目标尚不明确。我们将利用随机对照试验中的综合数据和单个患者数据进行系统回顾和荟萃分析,比较成人重症患者的强化血糖控制和宽松血糖控制:数据来源:MEDLINE®、Embase、Cochrane Clinical Trials Central Register 和临床试验登记处(世界卫生组织、clinical trials.gov)。将邀请符合条件的试验的作者提供单个患者数据。如果无法获得患者个体数据,则将在汇总数据荟萃分析中纳入符合条件且不存在高偏倚风险的已发表试验级数据:纳入标准:招募成年患者的随机对照试验,目标血糖≤120mg/dL(≤6.6mmol/L)与两组患者使用静脉注射胰岛素的较高血糖浓度目标进行比较。排除的研究:干预组血糖目标上限> 120mg/dL(> 6.6mmol/L)的研究,或仅在术中进行强化血糖控制的研究,以及出院时随访损失超过10%的研究。次要终点:其他时间点的死亡率和存活率、有创机械通气持续时间、血管活性药物和肾脏替代疗法。将采用随机效应贝叶斯荟萃分析和分层贝叶斯模型对单个患者数据进行分析:该系统性综述包括总体数据和单个患者数据,将解决 "重症患者的最佳血糖目标是什么?
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