A41
Conditions
Interventions
Group 1: The primary goal of the INTACT-ICU study is to classify critically ill patients based on their immune status and to make predictive assessments regarding potential secondary infections within
Sponsors
TUM Universtitätsklinikum
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The diagnosis of critical illness is made based on the presence of isolated or multiple organ failures, defined as follows: 1) Acute kidney injury according to KDIGO Stage 1 (increase in serum creatinine by =0.3 mg/dL, or an increase to 1.5–1.9 times baseline, or urine output 200 mm Hg and =300 mm Hg). 3) Liver failure, defined by a total bilirubin level >5 mg/dL (85 µmol/L) and an international normalized ratio (INR) >1.5. 4) Volume-refractory hypotension, defined by a need for vasopressors >0.6 µg/min/kg body weight despite adequate fluid resuscitation. 5) Acute cerebral dysfunction, such as an initial Glasgow Coma Scale (GCS) score 10 mm Hg, or the presence of an acute subarachnoid hemorrhage or subdural hematoma. 6) A SOFA (Sequential Organ Failure Assessment) score greater than 2.
Exclusion criteria
Exclusion criteria: age <18yrs preexisting immune deficiency immune suppressive therapy with recent 3 month transfer from other ICU active HIV or hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the identification of patient groups who develop an ICU-acquired infection during their stay due to a dysregulated immune system. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints, are the underlying mechanisms and signaling pathways, as well as hospital length of stay, mortality risk, readmission rate within the following year. | — |
Countries
Germany
Contacts
Public ContactMartin Schlegel
TU Universitätsklinikum
Outcome results
None listed