Clinical trial NCT06511622: Impact of Immune Status on Secondary Infections in Patients With Acute Respiratory Failure
Official title: Impact of Immune Status on Secondary Infections in Patients With Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ARDS
Keywords: ARDS
ECMO
Herpes viridae
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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:

* None

Primary outcomes:
measure: Herpes simplex reactivation
timeFrame: 01/2019- 02/2024
measure: Cytomegalovirus reactivation
timeFrame: 01/2019- 02/2024
measure: Epstein Barr virus reactivation
timeFrame: 01/2019- 02/2024
measure: B cells (CD19 positive)
timeFrame: 01/2019- 02/2024
measure: Natural killer cells Cells (CD16 pos)
timeFrame: 01/2019- 02/2024
measure: T helper cells (CD4)
timeFrame: 01/2019- 02/2024
measure: Cytotoxic T cells (CD8)
timeFrame: 01/2019- 02/2024
measure: HLA-DR expression on monocytes
timeFrame: 01/2019- 02/2024
Secondary outcomes:
measure: Beginn weaning
timeFrame: 01/2019- 02/2024
measure: Extracorporeal membrane oxygenation duration
timeFrame: 01/2019- 02/2024
measure: Costs of treatment
timeFrame: 01/2019- 02/2024
measure: Pathogen persistence after guideline-compliant therapy (yes/no)
timeFrame: 01/2019- 02/2024
measure: Ventilator-associated pneumonia (yes/no)
timeFrame: 01/2019- 02/2024
measure: Occurrence of fungal pneumonia (yes/no)
timeFrame: 01/2019- 02/2024
measure: Mortality
timeFrame: 01/2019- 02/2024
measure: Sequential Organ Failure Assessment (SOFA score)
timeFrame: 01/2019- 02/2024
measure: Simplified Acute Physiology Score (SAPS II)
timeFrame: 01/2019- 02/2024
measure: Pre-existing conditions
timeFrame: 01/2019- 02/2024
measure: Concomitant infections with therapy
timeFrame: 01/2019- 02/2024
measure: Volumes
timeFrame: 01/2019- 02/2024
measure: Ventilation parameters
timeFrame: 01/2019- 02/2024
measure: Catecholamine doses
timeFrame: 01/2019- 02/2024
measure: Number of catecholamine days
timeFrame: 01/2019- 02/2024
measure: Recording of end organ damage such as liver and kidney failure
timeFrame: 01/2019- 02/2024
measure: Diagnoses during the intensive care stay
timeFrame: 01/2019- 02/2024
measure: Administration of immunosuppressants
timeFrame: 01/2019- 02/2024
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - University Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: