Faculty of Medicine, Osaka Medical College, Takatsuki, Osaka, Japan.
Department of Traumatology and Acute Critical Medicine, Osaka University School of Medicine Graduate School of Medicine, Suita, Osaka, Japan.
BMJ Open. 2021 Mar 19;11(3):e048512. doi: 10.1136/bmjopen-2020-048512.
The optimal target of mean arterial pressure (MAP) for better outcomes in patients with vasodilatory shock remains a matter of debate. Although catecholamines are generally used to maintain target blood pressure in hypotensive patients with vasodilatory shock, the adverse effects of catecholamines must also be considered. We will perform a systematic review and meta-analysis of randomised controlled trials (RCTs) to assess the certainty of evidence determining the optimal target of MAP control for patients with vasodilatory shock in critically ill settings.
This study protocol was registered in the University Hospital Medical Information Network Clinical Trials Registry. We will include only RCTs that evaluated the two different comparators for target MAP to be maintained for clinical outcomes of all-cause mortality: organ dysfunction and adverse events in critically ill adult patients with vasodilatory shock. We will search the electronic bibliographic databases of MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials in November 2020. Two reviewers will independently screen titles and abstracts, perform full article reviews and extract study data. We will report study characteristics and assess methodological quality using the Cochrane Risk-of-Bias 2 tool. If pooling is appropriate, we will calculate relative risks with 95% CIs for all outcome measures. Clinical and methodological subgroup and sensitivity analyses will be performed to explore heterogeneity. Overall certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.
This study will not involve primary data collection, and formal ethics approval will therefore not be required. We aim to publish this systematic review in a peer-reviewed journal.
UMIN000042624.
在血管扩张性休克患者中，为了获得更好的结果，平均动脉压（MAP）的最佳目标仍然存在争议。虽然儿茶酚胺通常用于维持血管扩张性休克低血压患者的目标血压，但也必须考虑儿茶酚胺的不良反应。我们将对随机对照试验（RCT）进行系统评价和荟萃分析，以评估确定血管扩张性休克危重症患者 MAP 控制最佳目标的证据确定性。
本研究方案已在大学医院医疗信息网络临床试验注册中心注册。我们将仅纳入评估两种不同目标 MAP 比较的 RCT，以评估所有原因死亡率、器官功能障碍和不良事件等临床结局：血管扩张性休克危重症成年患者的临床结局。我们将于 2020 年 11 月检索 MEDLINE、EMBASE 和 Cochrane 对照试验中心注册数据库的电子文献数据库。两名审查员将独立筛选标题和摘要，进行全文审查并提取研究数据。我们将报告研究特征，并使用 Cochrane 偏倚风险 2 工具评估方法学质量。如果适合汇总，我们将计算所有结局指标的相对风险及其 95%置信区间。将进行临床和方法亚组及敏感性分析，以探索异质性。使用推荐评估、制定和评估方法来评估证据的总体确定性。
本研究不涉及原始数据收集，因此不需要正式的伦理批准。我们的目标是在同行评议的期刊上发表这篇系统评价。
UMIN000042624。
