AgingPOPIMAGENCT05368896
Peri-operative Inflammaging in the Elderly After Surgery
An observational study of Aging and Immunology, run by University of Bonn at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Aging, Immunology, Postoperative Complications
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 1 Dec 2022to 30 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients ≥ 80 years undergoing major surgery
Who may be able to join
- age ≥ 80 years
- elective major surgery defined as knee / hip replacement, spondylodesis (> 2 levels), gastrectomy, resection of esophagus, liver, pancreas, colon, rectum or lung
Who cannot join
- 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:
Show all 18Show fewer
- 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 locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Bonn
Bonn, 53127
Christian Bode, MD, +4922828714110, christian.bode@ukbonn.de
About this study
Official title: Peri-OPerative InflamMAGing in Elderly Patients Undergoing Major Surgery: Prediction and Pathomechanisms of Post-operative Morbidities
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
- Medical subject headings
- Postoperative Complications, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly patients with postoperative complications after major surger | Patients >80 years that will undergo major visceral or orthopedic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30
Number of patients with death from any cause
Measured: 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
Measured: 30 days
Secondary outcomes (11)
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
Measured: 30 days
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
Measured: 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.
Measured: 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.
Measured: 30 days
Unplanned intensive care unit admission
Number of patients
Measured: 30 days
Unplanned intubation after intervention
Number of patients
Measured: 30 days
Analysis of the new-onset of sepsis
Number of patients diagnoses by SEPSIS-3 definition
Measured: 30 days
Analysis of the new-onset surgical side infection
Number of patients
Measured: 30 days
Ventilator dependency >48 h
duration of mechanical ventilation
Measured: 48 hours
Analysis of the new-onset thrombosis
number of patients with (deep) vein thrombosis
Measured: 30 days
all cause mortality
Number of patients with death from any cause
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Dec 2022
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bonn
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Christian Bode, University of Bonn
- Investigators
- Mark Coburn, Prof, Study chair, mark.coburn@ukbonn.de
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368896
- Sponsor's protocol ID
- KAI-1
- Acronym
- POPIMAGE
- Status last verified
- Feb 2023
- First submitted
- 5 Apr 2022
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-OPerative InflamMAGing in Elderly Patients Undergoing Major Surgery: Prediction and Pathomechanisms of Post-operative Morbidities
- ClinicalTrials.gov ID
- NCT05368896
- Acronym / sponsor ID
- POPIMAGE / KAI-1
- Conditions
- Aging, Immunology, Postoperative Complications, Surgery
- Keywords
- Frailty, Neuro-Degenerative Disease, innate immunity, immunphenotyping
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of BonnUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elderly patients with postoperative complications after major surger | – | –Patients >80 years that will undergo major visceral or orthopedic surgery |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients ≥ 80 years undergoing major surgery
Key inclusion criteria (2 listed)
- age ≥ 80 years
- elective major surgery defined as knee / hip replacement, spondylodesis (> 2 levels), gastrectomy, resection of esophagus, liver, pancreas, colon, rectum or lung
Key exclusion criteria (18 listed)
- no informed consent
- not able to perform neurocognitive testing
- preexisting infection systemic: CRP>100 mg/l, Leukos >12.0 G/l or clinical signs
- PJI is present when 1 major criteria exist or 4 out of 6 minor criteria exist
- 2 positive periprosthetic cultures with phenotypically identical organisms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30
Time frame: 30 days
Number of patients with death from any cause
In-hospital outcome according to the ACS National Surgical Quality Improvement Program® (ACS NSQIP®)
Time frame: 30 days
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
11 secondary outcomes
Analysis of the new-onset of serious cardiac complications
Time frame: 30 days
Analysis of the new-onset of serious pulmonary complications
Time frame: 30 days
Analysis of the new-onset of acute stroke
Time frame: 30 days
Analysis of the new-onset of acute kidney injury
Time frame: 30 days
Unplanned intensive care unit admission
Time frame: 30 days
Unplanned intubation after intervention
Time frame: 30 days
Analysis of the new-onset of sepsis
Time frame: 30 days
Analysis of the new-onset surgical side infection
Time frame: 30 days
Ventilator dependency >48 h
Time frame: 48 hours
Analysis of the new-onset thrombosis
Time frame: 30 days
all cause mortality
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Coburn, Prof study chair
mark.coburn@ukbonn.de
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging and Immunology, run by University of Bonn at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christian Bode, MD (+4922828714110, christian.bode@ukbonn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-interventional (surgical and non-surgical interventional) all-cause mortality rate on day 30 (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.