Peri-operative Inflammaging in the Elderly After Surgery

NCT ID: NCT05368896

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-01
• Study Completion Date: 2025-03-30

Brief 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.

Conditions

Aging; Immunology; Postoperative Complications; Surgery

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Elderly patients with postoperative complications after major surger

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

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bonn

OTHER

Sponsor Role: lead

Responsible Party

Dr. Christian Bode

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark Coburn, Prof

Role: STUDY_CHAIR

mark.coburn@ukbonn.de

Locations

University Hospital Bonn

Bonn, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christian Bode, MD

Role: CONTACT

christian.bode@ukbonn.de

+4922828714110

Facility Contacts

Christian Bode, MD

Role: primary

christian.bode@ukbonn.de

+4922828714110

Other Identifiers

KAI-1

Identifier Type: -

Identifier Source: org_study_id