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临床试验/NCT06511622
NCT06511622已完成不适用

Impact of Immune Status on Secondary Infections in Patients With Acute Respiratory Failure

Charite University, Berlin, Germany2 个研究点 分布在 1 个国家目标入组 686 人开始时间: 2024年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
686
试验地点
2
主要终点
Natural killer cells Cells (CD16 pos)

研究概览

简要总结

This is a retrospective observational study over the period 1/2019 - 02/2024 with the aim of identifying patients with a predisposition to secondary infections.

详细描述

As a reference center, Charité Universitaetsmedizin Berlin has been treating patients with the most severe form of acute respiratory failure, known as acute respiratory distress syndrome (ARDS), for more than 30 years. Despite lung-protective forms of ventilation and the use of extracorporeal procedures for oxygenation and decarboxylation (ECMO), mortality is around forty percent. In addition to the primary cause of ARDS, further infectious complications often develop during the course of the disease, which delay recovery.

The aim of this study is to investigate infectious complications (ventilator-associated pneumonia, reactivation of Herpes viridae, pathogen resistance despite formally correct therapy, fungal infections) depending on the immune status.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female acute respiratory distress syndrome patients who had an immune status within 48 h of admission
  • Patients who received intensive care treatment for acute respiratory distress syndrome ward 8i at Charité in the period from 01/2019 to 02/2024 with a maximum follow-up period of 90 days

排除标准

  • 未提供

结局指标

主要结局

Natural killer cells Cells (CD16 pos)

时间窗: 01/2019- 02/2024

Absolute number per nanoliter and percentage of lymphocytes.

HLA-DR expression on monocytes

时间窗: 01/2019- 02/2024

in molecules per cell

Herpes simplex reactivation

时间窗: 01/2019- 02/2024

semi-quantitatively with Herpes simplex (negative / slightly positive / positive and strongly positive) in blood or bronchial lavage

B cells (CD19 positive)

时间窗: 01/2019- 02/2024

Absolute number per nanoliter and percentage of lymphocytes

Cytomegalovirus reactivation

时间窗: 01/2019- 02/2024

as absolute copy number per milliliter of blood or bronchioalveolar lavage

Cytotoxic T cells (CD8)

时间窗: 01/2019- 02/2024

Absolute number per nanoliter and percentage of lymphocytes

Epstein Barr virus reactivation

时间窗: 01/2019- 02/2024

absolute copy number per milliliter of blood or bronchioalveolar lavage

T helper cells (CD4)

时间窗: 01/2019- 02/2024

Aabsolute number per nanoliter and percentage of lymphocytes

Herpes simplex reactivation

时间窗: 01/2019- 12/2025

semi-quantitatively with Herpes simplex (negative / slightly positive / positive and strongly positive) in blood or bronchial lavage

Cytomegalovirus reactivation

时间窗: 01/2019- 12/2025

as absolute copy number per milliliter of blood or bronchioalveolar lavage

Epstein Barr virus reactivation

时间窗: 01/2019- 12/2025

absolute copy number per milliliter of blood or bronchioalveolar lavage

B cells (CD19 positive)

时间窗: 01/2019- 12/2025

Absolute number per nanoliter and percentage of lymphocytes

Natural killer cells Cells (CD16 pos)

时间窗: 01/2019- 12/2025

Absolute number per nanoliter and percentage of lymphocytes.

T helper cells (CD4)

时间窗: 01/2019- 12/2025

Aabsolute number per nanoliter and percentage of lymphocytes

Cytotoxic T cells (CD8)

时间窗: 01/2019- 12/2025

Absolute number per nanoliter and percentage of lymphocytes

HLA-DR expression on monocytes

时间窗: 01/2019- 12/2025

in molecules per cell

次要结局

  • Pathogen persistence after guideline-compliant therapy (yes/no)(01/2019- 02/2024)
  • Catecholamine doses(01/2019- 02/2024)
  • Number of catecholamine days(01/2019- 02/2024)
  • Recording of end organ damage such as liver and kidney failure(01/2019- 02/2024)
  • Costs of treatment(01/2019- 02/2024)
  • Ventilator-associated pneumonia (yes/no)(01/2019- 02/2024)
  • Concomitant infections with therapy(01/2019- 02/2024)
  • Volumes(01/2019- 02/2024)
  • Diagnoses during the intensive care stay(01/2019- 02/2024)
  • Administration of immunosuppressants(01/2019- 02/2024)
  • Extracorporeal membrane oxygenation duration(01/2019- 02/2024)
  • Occurrence of fungal pneumonia (yes/no)(01/2019- 02/2024)
  • Simplified Acute Physiology Score (SAPS II)(01/2019- 02/2024)
  • Beginn weaning(01/2019- 02/2024)
  • Ventilation parameters(01/2019- 02/2024)
  • Mortality(01/2019- 02/2024)
  • Sequential Organ Failure Assessment (SOFA score)(01/2019- 02/2024)
  • Pre-existing conditions(01/2019- 02/2024)
  • Beginn weaning(01/2019- 12/2025)
  • Extracorporeal membrane oxygenation duration(01/2019- 12/2025)
  • Costs of treatment(01/2019- 12/2025)
  • Pathogen persistence after guideline-compliant therapy (yes/no)(01/2019- 12/2025)
  • Ventilator-associated pneumonia (yes/no)(01/2019- 12/2025)
  • Occurrence of fungal pneumonia (yes/no)(01/2019- 12/2025)
  • Mortality(01/2019- 12/2025)
  • Sequential Organ Failure Assessment (SOFA score)(01/2019- 12/2025)
  • Simplified Acute Physiology Score (SAPS II)(01/2019- 12/2025)
  • Pre-existing conditions(01/2019- 12/2025)
  • Concomitant infections with therapy(01/2019- 12/2025)
  • Volumes(01/2019- 12/2025)
  • Ventilation parameters(01/2019- 12/2025)
  • Catecholamine doses(01/2019- 12/2025)
  • Number of catecholamine days(01/2019- 12/2025)
  • Recording of end organ damage such as liver and kidney failure(01/2019- 12/2025)
  • Diagnoses during the intensive care stay(01/2019- 12/2025)
  • Administration of immunosuppressants(01/2019- 12/2025)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Claudia Spies

Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK)

Charite University, Berlin, Germany

研究点 (2)

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