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

Recruiting

• Conditions: ARDS

• Registration Number: NCT06511622
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2024-06-10
• Study Start: 2024-07-10
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-22
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16
• Primary Completion: 2025-05-22
• Study Completion: 2025-05-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Natural killer cells Cells (CD16 pos)	01/2019- 02/2024	Absolute number per nanoliter and percentage of lymphocytes.
HLA-DR expression on monocytes	01/2019- 02/2024	in molecules per cell
Cytotoxic T cells (CD8)	01/2019- 02/2024	Absolute number per nanoliter and percentage of lymphocytes
Herpes simplex reactivation	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)	01/2019- 02/2024	Absolute number per nanoliter and percentage of lymphocytes
Cytomegalovirus reactivation	01/2019- 02/2024	as absolute copy number per milliliter of blood or bronchioalveolar lavage
Epstein Barr virus reactivation	01/2019- 02/2024	absolute copy number per milliliter of blood or bronchioalveolar lavage
T helper cells (CD4)	01/2019- 02/2024	Aabsolute number per nanoliter and percentage of lymphocytes

Secondary Outcome Measures

Name	Time	Method
Pathogen persistence after guideline-compliant therapy (yes/no)	01/2019- 02/2024
Catecholamine doses	01/2019- 02/2024	Name of catecholamines, inotropes and vasopressors
Number of catecholamine days	01/2019- 02/2024	Number of days with dose of norepinephrine \> 0.1 µg/kg/min for more than 30 min or equivalent dose of other catecholamines.
Recording of end organ damage such as liver and kidney failure	01/2019- 02/2024	Organ damage measured by routine laboratory
Beginn weaning	01/2019- 02/2024	Days until the first successful spontaneous breathing trial.
Costs of treatment	01/2019- 02/2024	Costs of treatment are measured by costs of particular microbiological diagnostics and therapy.
Ventilator-associated pneumonia (yes/no)	01/2019- 02/2024
Concomitant infections with therapy	01/2019- 02/2024	Results of microbiological diagnostics (growth- and molecular-based diagnostics) by specifying the name of the pathogen.
Volumes	01/2019- 02/2024	Volumes administered, incl. transfusions and coagulation factors
Diagnoses during the intensive care stay	01/2019- 02/2024	Diagnoses as the cause of ARDS, but also newly acquired diagnoses such as critical illness myopathy / polyneuropathy, renal failure.
Administration of immunosuppressants	01/2019- 02/2024	Administration of immunosuppressants like corticosteroid, chemotherapy, monoclonal antibodies within the last 3 months.
Extracorporeal membrane oxygenation duration	01/2019- 02/2024	Extracorporeal membrane oxygenation is measured in days
Occurrence of fungal pneumonia (yes/no)	01/2019- 02/2024
Simplified Acute Physiology Score (SAPS II)	01/2019- 02/2024	Routine patient treatment data - score is measured numerically (0 - 163)
Ventilation parameters	01/2019- 02/2024	Recording of ventilation parameters such as airway, ventilation mode and start of ventilation weaning.
Mortality	01/2019- 02/2024	ITS mortality and hospital mortality are measured.
Sequential Organ Failure Assessment (SOFA score)	01/2019- 02/2024	Routine patient treatment data - score is measured numerically (0 - 24) Routine patient treatment data.
Pre-existing conditions	01/2019- 02/2024	Classified recording of previous illnesses (e.g. haematological diseases, tumour diseases, chronic heart failure, etc.) from the medical file.

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin; 🇩🇪 Berlin, Germany