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Clinical Trials/NCT06511622
NCT06511622
Recruiting
Not Applicable

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

Charite University, Berlin, Germany1 site in 1 country200 target enrollmentJuly 10, 2024
ConditionsARDS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ARDS
Sponsor
Charite University, Berlin, Germany
Enrollment
200
Locations
1
Primary Endpoint
Natural killer cells Cells (CD16 pos)
Status
Recruiting
Last Updated
3 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 10, 2024
End Date
March 31, 2026
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Claudia Spies

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

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Natural killer cells Cells (CD16 pos)

Time Frame: 01/2019- 02/2024

Absolute number per nanoliter and percentage of lymphocytes.

HLA-DR expression on monocytes

Time Frame: 01/2019- 02/2024

in molecules per cell

Herpes simplex reactivation

Time Frame: 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)

Time Frame: 01/2019- 02/2024

Absolute number per nanoliter and percentage of lymphocytes

Cytomegalovirus reactivation

Time Frame: 01/2019- 02/2024

as absolute copy number per milliliter of blood or bronchioalveolar lavage

Cytotoxic T cells (CD8)

Time Frame: 01/2019- 02/2024

Absolute number per nanoliter and percentage of lymphocytes

Epstein Barr virus reactivation

Time Frame: 01/2019- 02/2024

absolute copy number per milliliter of blood or bronchioalveolar lavage

T helper cells (CD4)

Time Frame: 01/2019- 02/2024

Aabsolute number per nanoliter and percentage of lymphocytes

Secondary Outcomes

  • 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)

Study Sites (1)

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