The population older than 80 years will significantly increase in the near future. Older patients' cognitive and physical status is known to deteriorate after surgery, leading to a high 30-day mortality due to post-operative comorbidities. Aging and related diseases share immune-related pathomechanisms. During aging, a chronic, low-grade sterile inflammation, called inflamaging, gradually develops. This likely results from low-grade innate immune activation and a functional, epigenomic and transcriptomic reprogramming of immune cells. Based on the hypothesis that surgical trauma leads to misplaced or altered self-molecules, which exacerbate inflammation and the postoperative risk for morbidity and mortality in elderly patients. There is increasing evidence that the individual's pre-operative immunobiography determines the susceptibility to peri-operative inflammation and post-operative outcome. Current exploratory pilot study will thus perform phenotyping of patients above 80 years undergoing major surgery. Participants will be evaluated for acute and long-term outcomes, including all-cause mortality, physical and cognitive function. To assess the individual's immunobiography, participants will be characterised by inflammation biomarkers combined with immunophenotyping, functional assays, and (epi-) genomic analyses before and after surgery. The cognitive impairment will be evaluated by measuring markers of neurodegeneration and neuropsychiatric testing and relate findings to volumetric imaging using high-resolution MRI to identify brain changes associated with cognitive decline.
Study Type
OBSERVATIONAL
Enrollment
150
University Hospital Bonn
Bonn, Germany
RECRUITINGPeri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30
Number of patients with death from any cause
Time frame: 30 days
In-hospital outcome according to the ACS National Surgical Quality Improvement Program® (ACS NSQIP®)
Number of patients with e.g. pneumonia, cardiovascular complication, surgical site infection, urinary tract infection, venous thromboembolism, acute or progressive renal failure and re-surgery
Time frame: 30 days
Analysis of the new-onset of serious cardiac complications
Number of patients with serious cardiac complication Cardiac complication is defined according to the American Heart Association
Time frame: 30 days
Analysis of the new-onset of serious pulmonary complications
Number of patients with Pneumonia: Clinical or radiological diagnosis. or Pulmonary embolism: Radiological diagnosis. Signs of pneumonia or pulmonary embolism in the autopsy
Time frame: 30 days
Analysis of the new-onset of acute stroke
Number of patients with new-onset of acute stroke, defined as a new focal or generalised neurological deficit of \>24h duration in motor, sensory, or coordination functions with compatible brain imaging and confirmed by a neurologist. Transient ischemic attack is not considered as acute stroke. Signs of stroke in the autopsy.
Time frame: 30 days
Analysis of the new-onset of acute kidney injury
Number of patients with new-onset of acute kidney injury, defined according to the AKIN classification as AKI stage ≥2. This means increase of creatinine \>2-3x from baseline within the hospital stay. Or urine output less than 0.5 ml kg-1 per hour for more than 12 hours. Or signs of acute kidney injury in the autopsy.
Time frame: 30 days
Unplanned intensive care unit admission
Number of patients
Time frame: 30 days
Unplanned intubation after intervention
Number of patients
Time frame: 30 days
Analysis of the new-onset of sepsis
Number of patients diagnoses by SEPSIS-3 definition
Time frame: 30 days
Analysis of the new-onset surgical side infection
Number of patients
Time frame: 30 days
Ventilator dependency >48 h
duration of mechanical ventilation
Time frame: 48 hours
Analysis of the new-onset thrombosis
number of patients with (deep) vein thrombosis
Time frame: 30 days
all cause mortality
Number of patients with death from any cause
Time frame: 12 month
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