Peri-operative Inflammaging in the Elderly After Surgery

NCT05368896 | Unknown

• 1 other identifier: KAI-1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Frailty; Neuro-Degenerative Disease; innate immunity; immunphenotyping

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (11)

• Analysis of the new-onset of serious cardiac complications

  30 days

• Analysis of the new-onset of serious pulmonary complications

  30 days

• Analysis of the new-onset of acute stroke

  30 days

• Analysis of the new-onset of acute kidney injury

  30 days

• Unplanned intensive care unit admission

  30 days

Study Arms (1)

Elderly patients with postoperative complications after major surger

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

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients ≥ 80 years undergoing major surgery

You may qualify if:

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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• University of Bonn: lead

Study Sites (1)

University Hospital Bonn

Bonn, 53127, Germany

RECRUITING

MeSH Terms

Conditions

Postoperative Complications; Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mark Coburn, Prof

  mark.coburn@ukbonn.de

  STUDY CHAIR

Central Study Contacts

Christian Bode, MD

CONTACT

+4922828714110; christian.bode@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: May 10, 2022
• Study Start: December 1, 2022
• Primary Completion: December 30, 2024
• Study Completion: March 30, 2025
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

DE (1)