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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Herpes simplex reactivation | semi-quantitatively with Herpes simplex (negative / slightly positive / positive and strongly positive) in blood or bronchial lavage | 01/2019- 12/2025 |
| Cytomegalovirus reactivation | as absolute copy number per milliliter of blood or bronchioalveolar lavage | 01/2019- 12/2025 |
| Epstein Barr virus reactivation | absolute copy number per milliliter of blood or bronchioalveolar lavage | 01/2019- 12/2025 |
| B cells (CD19 positive) | Absolute number per nanoliter and percentage of lymphocytes | 01/2019- 12/2025 |
| Natural killer cells Cells (CD16 pos) | Absolute number per nanoliter and percentage of lymphocytes. | 01/2019- 12/2025 |
| T helper cells (CD4) | Aabsolute number per nanoliter and percentage of lymphocytes | 01/2019- 12/2025 |
| Cytotoxic T cells (CD8) | Absolute number per nanoliter and percentage of lymphocytes | 01/2019- 12/2025 |
| HLA-DR expression on monocytes | in molecules per cell |
| Measure | Description | Time Frame |
|---|---|---|
| Beginn weaning | Days until the first successful spontaneous breathing trial. | 01/2019- 12/2025 |
| Extracorporeal membrane oxygenation duration | Extracorporeal membrane oxygenation is measured in days |
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Inclusion Criteria:
Exclusion Criteria:
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Male and female patients who received intensive care treatment for acute respiratory distress syndrome on ward 8i at Charité in the period from 01/2019 to 02/2024 with a maximum follow-up period of 90 days.
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, MD, Prof. | Charite University, Berlin, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin | Berlin | 10117 | Germany |
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| 01/2019- 12/2025 |
| 01/2019- 12/2025 |
| Costs of treatment | Costs of treatment are measured by costs of particular microbiological diagnostics and therapy. | 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 | ITS mortality and hospital mortality are measured. | 01/2019- 12/2025 |
| Sequential Organ Failure Assessment (SOFA score) | Routine patient treatment data - score is measured numerically (0 - 24) Routine patient treatment data. | 01/2019- 12/2025 |
| Simplified Acute Physiology Score (SAPS II) | Routine patient treatment data - score is measured numerically (0 - 163) | 01/2019- 12/2025 |
| Pre-existing conditions | Classified recording of previous illnesses (e.g. haematological diseases, tumour diseases, chronic heart failure, etc.) from the medical file. | 01/2019- 12/2025 |
| Concomitant infections with therapy | Results of microbiological diagnostics (growth- and molecular-based diagnostics) by specifying the name of the pathogen. | 01/2019- 12/2025 |
| Volumes | Volumes administered, incl. transfusions and coagulation factors | 01/2019- 12/2025 |
| Ventilation parameters | Recording of ventilation parameters such as airway, ventilation mode and start of ventilation weaning. | 01/2019- 12/2025 |
| Catecholamine doses | Name of catecholamines, inotropes and vasopressors | 01/2019- 12/2025 |
| Number of catecholamine days | Number of days with dose of norepinephrine > 0.1 µg/kg/min for more than 30 min or equivalent dose of other catecholamines. | 01/2019- 12/2025 |
| Recording of end organ damage such as liver and kidney failure | Organ damage measured by routine laboratory | 01/2019- 12/2025 |
| Diagnoses during the intensive care stay | Diagnoses as the cause of ARDS, but also newly acquired diagnoses such as critical illness myopathy / polyneuropathy, renal failure. | 01/2019- 12/2025 |
| Administration of immunosuppressants | Administration of immunosuppressants like corticosteroid, chemotherapy, monoclonal antibodies within the last 3 months. | 01/2019- 12/2025 |