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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elderly patients with postoperative complications after major surger | Patients >80 years that will undergo major visceral or orthopedic surgery |
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| Measure | Description | Time Frame |
|---|---|---|
| Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30 | Number of patients with death from any cause | 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Analysis of the new-onset of serious pulmonary complications |
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Inclusion Criteria:
Exclusion Criteria:
Prosthetic joint infection (MSIS 2011 criteria):
PJI is present when 1 major criteria exist or 4 out of 6 minor criteria exist
Major criteria:
Minor criteria:
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Patients ≥ 80 years undergoing major surgery
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christian Bode, MD | Contact | +4922828714110 | christian.bode@ukbonn.de |
| Name | Affiliation | Role |
|---|---|---|
| Mark Coburn, Prof | mark.coburn@ukbonn.de | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Bonn | Recruiting | Bonn | 53127 | Germany |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D000073496 | Frailty |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Number of patients with Pneumonia: Clinical or radiological diagnosis. or Pulmonary embolism: Radiological diagnosis. Signs of pneumonia or pulmonary embolism in the autopsy |
| 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. | 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. | 30 days |
| Unplanned intensive care unit admission | Number of patients | 30 days |
| Unplanned intubation after intervention | Number of patients | 30 days |
| Analysis of the new-onset of sepsis | Number of patients diagnoses by SEPSIS-3 definition | 30 days |
| Analysis of the new-onset surgical side infection | Number of patients | 30 days |
| Ventilator dependency >48 h | duration of mechanical ventilation | 48 hours |
| Analysis of the new-onset thrombosis | number of patients with (deep) vein thrombosis | 30 days |
| all cause mortality | Number of patients with death from any cause | 12 month |