Peri-operative Inflammaging in the Elderly After Surgery

Surgery Clinical Trial

— POPIMAGE  

Official title:

Peri-OPerative InflamMAGing in Elderly Patients Undergoing Major Surgery: Prediction and Pathomechanisms of Post-operative Morbidities

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05368896
• Other study ID #: KAI-1
• Status: Recruiting
• Start date: December 1, 2022
• Est. completion date: March 30, 2025

Study information

• Verified date: February 2023
• Source: University of Bonn
• Contact: Christian Bode, MD
• Phone: +4922828714110
• Email: christian.bode[@]ukbonn.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: March 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 80 Years and older

Eligibility

Inclusion Criteria:

• age = 80 years
• elective major surgery defined as knee / hip replacement, spondylodesis (> 2 levels), gastrectomy, resection of esophagus, liver, pancreas, colon, rectum or lung

Exclusion Criteria:

• no informed consent
• not able to perform neurocognitive testing
• preexisting infection systemic: CRP>100 mg/l, Leukos >12.0 G/l or clinical signs Prosthetic joint infection (MSIS 2011 criteria): PJI is present when 1 major criteria exist or 4 out of 6 minor criteria exist

Major criteria:

• 2 positive periprosthetic cultures with phenotypically identical organisms
• A sinus tract communicating with the joint

Minor criteria:

• Elevated CRP and ESR
• Elevated synovial fluid WBC count or ++ change on leukocyte esterase test strip
• Elevated synovial fluid PMN%
• Presence of purulence in the affected joint
• Positive histologic analysis of periprosthetic tissue
• A single positive culture
• Immunosuppression (HIV, glucocorticoids, immunosupressants)
• Autoimmune diseases
• ongoing or recent (<3 months) chemo/radiotherapy

Related Conditions & MeSH terms

• Aging
• Immunology
• Postoperative Complications
• Surgery

Locations

Country	Name	City	State
Germany	University Hospital Bonn	Bonn

Sponsors (1)

Lead Sponsor	Collaborator
University of Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30	Number of patients with death from any cause	30 days
Primary	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
Secondary	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
Secondary	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	30 days
Secondary	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
Secondary	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
Secondary	Unplanned intensive care unit admission	Number of patients	30 days
Secondary	Unplanned intubation after intervention	Number of patients	30 days
Secondary	Analysis of the new-onset of sepsis	Number of patients diagnoses by SEPSIS-3 definition	30 days
Secondary	Analysis of the new-onset surgical side infection	Number of patients	30 days
Secondary	Ventilator dependency >48 h	duration of mechanical ventilation	48 hours
Secondary	Analysis of the new-onset thrombosis	number of patients with (deep) vein thrombosis	30 days
Secondary	all cause mortality	Number of patients with death from any cause	12 month