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Intensive Care Outcome Prediction Using Admission Carbohydrate-deficient Transferrin (IMPACT)

2026年7月2日 更新者:Juergen Grafeneder、Medical University of Vienna

IMPACT - Intensive Care Outcome Prediction Using Admission Carbohydrate-deficient Transferrin A Prospective Single-center Cohort Study

The goal of this observational study is to learn whether hazardous alcohol consumption, measured objectively by carbohydrate-deficient transferrin (CDT) levels at intensive care unit (ICU) admission, is associated with worse outcomes in critically ill patients. The main question it aims to answer is:

Do elevated CDT levels at ICU admission predict increased short-term mortality and adverse clinical outcomes in adult non-traumatic ICU patients? Participants admitted to the intensive care unit via the emergency department will have CDT levels measured as part of the study. Researchers will then collect and analyze clinical data, including mortality, duration of mechanical ventilation, delirium, ICU length of stay, renal replacement therapy, and ICU readmission rates, during hospitalization and follow-up.

研究概览

研究类型

观察性的

注册 (估计的)

800

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。

学习联系方式

学习地点

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

Study participants will be selected from adult patients admitted to the Department of Emergency Medicine who are subsequently transferred to an in-house intensive care unit (ICU). The study population consists of critically ill non-traumatic ICU patients receiving routine emergency and intensive care treatment.

描述

Inclusion Criteria:

  • all patients ≥ 18 admitted to the Department of Emergency Medicine and subsequently transferred to an in-house intensive care unit (ICU)

Exclusion Criteria:

  • Patients transferred to other hospital departments prior to completion of intensive care
  • Patients admitted directly to the ICU without passing the ED
  • Patients admitted to intermediate care units
  • Patients with pre-existing or newly diagnosed hepatic cirrhosis
  • Patients with known or obvious pregnancy will be excluded.
  • Patients with no vascular access

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

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
The primary outcome of the study is 30-day all-cause mortality in ICU patients.
大体时间:From ICU admission to 30 days after ICU admission
30-day all-cause mortality is defined as death from any cause occurring within 30 days after ICU admission. Mortality status will be assessed using patient medical records and, if unavailable, through the Austrian "Zentrales Personenstandsregister" (Central Civil Status Register), which documents registered deaths. Outcomes will be compared between patients with elevated and non-elevated carbohydrate-deficient transferrin (CDT) levels measured at ICU admission.
From ICU admission to 30 days after ICU admission

次要结果测量

结果测量
措施说明
大体时间
In-hospital mortality
大体时间:From hospital admission to hospital discharge evaluated 6 Months after study inclusion
Death from any cause occurring during the index hospital stay.
From hospital admission to hospital discharge evaluated 6 Months after study inclusion
ICU length of stay
大体时间:From ICU admission to ICU discharge evaluated 6 Months after study inclusion
Duration of stay in the intensive care unit, measured in days from ICU admission to ICU discharge.
From ICU admission to ICU discharge evaluated 6 Months after study inclusion
Duration of mechanical ventilation
大体时间:From initiation of mechanical ventilation to successful discontinuation during ICU stay evaluated 6 Months after study inclusion
Total duration of mechanical ventilation during the ICU stay, measured in hours or days.
From initiation of mechanical ventilation to successful discontinuation during ICU stay evaluated 6 Months after study inclusion
Illness severity score
大体时间:Evaluated from the documentation 6 Months after study inclusion
Severity of illness assessed using TISS(-A), with a higher score signaling higher severity
Evaluated from the documentation 6 Months after study inclusion
Illness severity score
大体时间:Evaluated from the documentation 6 Months after study inclusion
Severity of illness assessed using APACHE II , with a higher score signaling higher severity
Evaluated from the documentation 6 Months after study inclusion
Illness severity score
大体时间:Evaluated from the documentation 6 Months after study inclusion
Severity of illness assessed using SAPS II, with a higher score signaling higher severity
Evaluated from the documentation 6 Months after study inclusion
Illness severity score
大体时间:Evaluated from the documentation 6 Months after study inclusion
Severity of illness assessed using SOFA scores, with a higher score signaling higher severity
Evaluated from the documentation 6 Months after study inclusion

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)

2026年7月2日

初级完成 (估计的)

2028年6月1日

研究完成 (估计的)

2028年7月1日

研究注册日期

首次提交

2026年5月27日

首先提交符合 QC 标准的

2026年6月2日

首次发布 (实际的)

2026年6月8日

研究记录更新

最后更新发布 (实际的)

2026年7月6日

上次提交的符合 QC 标准的更新

2026年7月2日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

IPD 计划说明

De-identified individual participant data (IPD) underlying the reported study results, including demographic characteristics, laboratory values, CDT measurements, clinical parameters, and outcome data, may be shared upon reasonable request after publication of the primary results. Data containing directly identifiable personal information will not be shared in order to protect participant privacy and comply with applicable data protection regulations. Requests for access will be evaluated by the study investigators and institutional authorities.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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