Impact of Immune Status on Secondary Infections in Patients With Acute Respiratory Failure
NCT Number: NCT06511622
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: ARDS
Sponsor: Charite University, Berlin, Germany
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 200
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-07-10
Completion Date: 2025-05-22
Locations: Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin, Berlin, 10117, Germany

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.

Primary Outcome Measures: Herpes simplex reactivation, semi-quantitatively with Herpes simplex (negative / slightly positive / positive and strongly positive) in blood or bronchial lavage, 01/2019- 02/2024|Cytomegalovirus reactivation, as absolute copy number per milliliter of blood or bronchioalveolar lavage, 01/2019- 02/2024|Epstein Barr virus reactivation, absolute copy number per milliliter of blood or bronchioalveolar lavage, 01/2019- 02/2024|B cells (CD19 positive), Absolute number per nanoliter and percentage of lymphocytes, 01/2019- 02/2024|Natural killer cells Cells (CD16 pos), Absolute number per nanoliter and percentage of lymphocytes., 01/2019- 02/2024|T helper cells (CD4), Aabsolute number per nanoliter and percentage of lymphocytes, 01/2019- 02/2024|Cytotoxic T cells (CD8), Absolute number per nanoliter and percentage of lymphocytes, 01/2019- 02/2024|HLA-DR expression on monocytes, in molecules per cell, 01/2019- 02/2024
Secondary Outcome Measures: Beginn weaning, Days until the first successful spontaneous breathing trial., 01/2019- 02/2024|Extracorporeal membrane oxygenation duration, Extracorporeal membrane oxygenation is measured in days, 01/2019- 02/2024|Costs of treatment, Costs of treatment are measured by costs of particular microbiological diagnostics and therapy., 01/2019- 02/2024|Pathogen persistence after guideline-compliant therapy (yes/no), 01/2019- 02/2024|Ventilator-associated pneumonia (yes/no), 01/2019- 02/2024|Occurrence of fungal pneumonia (yes/no), 01/2019- 02/2024|Mortality, ITS mortality and hospital mortality are measured., 01/2019- 02/2024|Sequential Organ Failure Assessment (SOFA score), Routine patient treatment data - score is measured numerically (0 - 24) Routine patient treatment data., 01/2019- 02/2024|Simplified Acute Physiology Score (SAPS II), Routine patient treatment data - score is measured numerically (0 - 163), 01/2019- 02/2024|Pre-existing conditions, Classified recording of previous illnesses (e.g. haematological diseases, tumour diseases, chronic heart failure, etc.) from the medical file., 01/2019- 02/2024|Concomitant infections with therapy, Results of microbiological diagnostics (growth- and molecular-based diagnostics) by specifying the name of the pathogen., 01/2019- 02/2024|Volumes, Volumes administered, incl. transfusions and coagulation factors, 01/2019- 02/2024|Ventilation parameters, Recording of ventilation parameters such as airway, ventilation mode and start of ventilation weaning., 01/2019- 02/2024|Catecholamine doses, Name of catecholamines, inotropes and vasopressors, 01/2019- 02/2024|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- 02/2024|Recording of end organ damage such as liver and kidney failure, Organ damage measured by routine laboratory, 01/2019- 02/2024|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- 02/2024|Administration of immunosuppressants, Administration of immunosuppressants like corticosteroid, chemotherapy, monoclonal antibodies within the last 3 months., 01/2019- 02/2024