Peri-operative Inflammaging in the Elderly After Surgery (POPIMAGE)

University of Bonn

Status: Enrolling

Conditions: Postoperative Complications; Aging; Immunology; Surgery

Study type: Observational

Funder types: Other

Identifiers

NCT05368896

KAI-1

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 80+ years old

Volunteers: No Healthy Volunteers

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

Trial design

150 participants in 1 patient group

Elderly patients with postoperative complications after major surger

Description:

Patients \>80 years that will undergo major visceral or orthopedic surgery