Long-term Cognitive and Cerebral Changes in Sepsis Survivors and Their Predictors (BonSEP)
Severe Sepsis With Septic Shock, Severe Sepsis Without Septic Shock
About this trial
This is an interventional other trial for Severe Sepsis With Septic Shock focused on measuring sepsis, septic shock, ICU, long-term outcome, neurocognitive, inflammatory, MRI, EEG, brain imaging, serum biomarkers, CSF
Eligibility Criteria
INCLUSION CRITERIA:
sepsis/septic shock subjects will only be included in the study if they meet all of the following criteria:
- Written informed consent of the subject. or legal representative patient at the Anesthesiological-Operative Intensive Care Unit of the University Hospital Bonn, the Department of Anesthesiology, Intensive Care and Pain Therapy of the Malteser Hospital, or the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine of the Gemeinschaftskrankenhaus Bonn St. Petrus Hospital. At the Anesthesiological-Operative Intensive Care Unit of the University Hospital Bonn, only, or 1) documentation of presumed will via a relative or legal representative . together with 2) Documentation of verification by a doctor independent of the study that the patient's study participation is unobjectionable. Written informed consent of patient will be obtained at the earliest time possible.
- Aged 25-80 years
- Male or female
- Admitted to the intensive care units of the Anesthesiological-Operative Intensive Care Unit of the University Hospital Bonn, from the Department of Anesthesiology, Intensive Care and Pain Therapy of the Malteser Hospital or from the Department of Anesthesiology, Intensive Care Medicine and Pain Medicine of the Gemeinschaftskrankenhaus Bonn St. Petrus Hospital.
- Duration of ICU stay must be a minimum of 24 hours. In case of transfer to intermediate care or the observation ward before the 24 hour ICU period is complete, study parameters must be allowed to be assessed.
- Fulfill the criteria of sepsis and/or septic shock patients according to theThird International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3, Singer et al, 2016).
Postoperative ICU Patients will only be included in the study if they meet all of the following criteria:
- Written informed consent of the subject.
- Aged 25-80 years
- Male or female
- Admitted to the intensive care units of the Anesthesiological-Operative Intensive Care Unit of the University Hospital Bonn, which includes a surgical ICU, an anesthesiological ICU, and a cardio-surgical ICU
- Duration of ICU stay must be a minimum of 24 hours. In case of transfer to intermediate care or the observation ward before the 24 hour ICU period is complete, study parameters must be allowed to be assessed.
- Mini-Mental Status Examination (MMSE) Score of 25 or above
Healthy Controls will only be included in the study if they meet all of the following criteria:
- Written informed consent of the subject
- Aged 25-80 years
- Male or female
EXCLUSION CRITERIA:
Subjects presenting with any of the following exclusion criteria may not be included in the study:
- Simultaneous participation in any clinical treatment study involving administration of an investigational medicinal product within 30 days prior to study beginning
- Physical or psychiatric condition which at the investigator's discretion may put the subject at risk, may confound the study results, or may interfere with the subject's participation in this study
- Prior to the start of this study existence of preexisting severe diseases and/or conduction of surgery necessarily imply life expectancy less than 12 months
- Known or suspected persistent abuse of medication, drugs or alcohol now or in the past
- Known cerebral lesions, cerebral infarction or malignomas
- Dementia or history of other central nervous system diseases
- Cranial-cerebral injury
- Known HIV-Infection
- Known liver cirrhosis with a documented Child-Pugh Score of C prior to this study
- Liver transplants
- Prior to start of this study nursing care level of 2 or 3
- Prior to start of this study residing in a nursing home
Additional Exclusion Criteria For Non-Septic Postoperative ICU Patients:
- Fulfill the criteria of sepsis and/or septic shock patients according to theThird International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3, Singer et al, 2016).
- In the case that a postoperative ICU patient fulfills the criteria for sepsis during ICU stay, he/she will be moved to the sepsis group.
Additional Exclusion Criteria For Healthy:
- Executing third-party cognitive and functional assessments of another patient-subject also included in this investigation
- History of ICU stay in the last 12 months
Sites / Locations
- Department of Anesthesiology, University Hospital BonnRecruiting
- DZNE Center for Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
Sepsis/septic Shock
Postoperative ICU Patients
Healthy Controls
Men and women seen at the intensive care units of the Anesthesiology Department of the University Hospital Bonn aged 25-80; fulfill the criteria of sepsis and/or septic shock patients according to theThird International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3, Singer et al, 2016). Interventions: Neurocognitive Assessment, Clinical Scales, Questionnaires, Blood Sample, voluntary Lumbar Puncture, Resting State EEG, MRI
Men and women seen at the intensive care units of the Anesthesiology Department of the University Hospital Bonn aged 25-80: Admitted to the intensive care units of the Anesthesiological-Operative Intensive Care Unit of the University Hospital Bonn, which includes a surgical ICU, an anesthesiological ICU, and a cardio-surgical ICU Duration of ICU stay must be a minimum of 24 hours. Mini-Mental State Examination (MMSE) Score of 25 or above Interventions: Neurocognitive Assessment, Clinical Scales, Questionnaires, Blood Sample, voluntary Lumbar Puncture, Resting State EEG, MRI
Healthy Controls will only be included in the study if they meet all of the following criteria: Written informed consent of the subject, Aged 25-80 years, Male or female. Interventions: Neurocognitive Assessment, Clinical Scales, Questionnaires, Blood Sample, voluntary Lumbar Puncture, Resting State EEG, MRI