Occult Vasoplegia in Normotensive Sepsis: Early Prediction With Diastolic Index and Lactate (DIAL-SEPSIS)
2026年6月15日 更新者：Jose J Zaragoza, MD MSc、Hospital H+ Queretaro
Initial Diastolic Shock Index and Lactate as Predictors of Occult Vasoplegia in Normotensive Sepsis.
The goal of this observational study is to learn if the Diastolic Shock Index (DSI) and initial lactate can predict occult vasoplegia in adults with normotensive sepsis. Normotensive sepsis occurs in patients who have an apparently normal mean arterial pressure but may have impaired vascular tone.
The main questions it aims to answer are:
- Can an elevated DSI at admission predict the initiation of vasopressors (norepinephrine) within the first 6 hours of intensive care unit stay?
- How does the combination of initial DSI and lactate perform compared to each marker alone in predicting hemodynamic deterioration? Researchers will compare patients with an elevated DSI to those with a normal DSI to see if this index identifies those who will progress to circulatory shock.Since this is a retrospective cohort study using existing medical records, participants will not be asked to perform any tasks. Researchers will analyze anonymized data, such as heart rate, blood pressure, and lactate levels already recorded in the institutional database.
研究概览
研究类型
观察性的
注册 (实际的)
526
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Querétaro
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Querétaro City、Querétaro、墨西哥、7600
- Hospital H+
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
取样方法
非概率样本
研究人群
The study population consists of adult patients admitted to the Intensive Care Unit (ICU) of Hospital H+ Querétaro.
The cohort includes individuals with a diagnosis of sepsis (Sepsis-3) who maintain a mean arterial pressure (MAP) >=65 mmHg without the need for vasopressors during their initial hour of admission.
These patients are identified from an existing institutional database covering the period between January 1, 2024, and May 31, 2025.
The population represents a specific group of critically ill patients who, despite appearing hemodynamically stable (normotensive), are at risk of rapid progression to overt circulatory collapse and vasoplegia.
描述
Inclusion Criteria:
- Patients over 18 years of age.
- Diagnosis of sepsis upon admission according to Sepsis-3 criteria (suspected or confirmed infection plus an increase in SOFA score >2).
- Mean Arterial Pressure (MAP) during the first hour >=65 mmHg.
- No vasopressor infusion at the time of initial assessment (Time 0)
Exclusion Criteria:
- Patients who died within the first 24 hours of admission.
- Patients transferred out of the unit within the first 24 hours
- Patients who were already receiving vasopressor support in the pre-hospital setting or the emergency department before ICU admission.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Elevated Diastolic Shock Index (DSI)
Adult patients (>=18 years) admitted to the ICU with a diagnosis of sepsis (Sepsis-3 criteria) who are normotensive upon arrival (MAP >= 65 mmHg) and not yet receiving vasopressor support, but who present with a Diastolic Shock Index above the optimal cutoff point determined during analysis.
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Normal Diastolic Shock Index (DSI)
Adult patients (>=18 years) admitted to the ICU with a diagnosis of sepsis (Sepsis-3 criteria) who are normotensive upon arrival (MAP >= 65 mmHg) and not receiving vasopressor support, with a Diastolic Shock Index and lactate levels within normal ranges.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Initiation of norepinephrine (vasopressor).
大体时间：Within the first 6 hours of ICU admission.
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Predictive accuracy, measured by the Area Under the ROC Curve (AUC-ROC), of the initial Diastolic Shock Index (DSI), initial Lactate, and their combination to predict the requirement for norepinephrine.
A cutoff point will be defined using the Youden index.
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Within the first 6 hours of ICU admission.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年1月1日
初级完成 (实际的)
2026年4月1日
研究完成 (实际的)
2026年4月1日
研究注册日期
首次提交
2026年6月15日
首先提交符合 QC 标准的
2026年6月15日
首次发布 (实际的)
2026年6月18日
研究记录更新
最后更新发布 (实际的)
2026年6月18日
上次提交的符合 QC 标准的更新
2026年6月15日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.