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ID
Source
Brief title
Health condition
Chronic Limb Threatening Ischemia (CLTI)
Sponsors and support
Intervention
Outcome measures
Primary outcome
Postoperative delirium
Secondary outcome
Secondary outcomes will be in-hospital mortality, 30 day, 6 month and 12 month mortality, complications, rates of major amputations, amputation free survival (AFS), length of hospital stay, Quality of Life (QoL, measured by using the WHOQOL-BREF, SF-12 and VascuQoL-6-NL), functional outcome, cognitive function and biochemistry.
Background summary
The primary aim of our study is to reduce the incidence of delirium among patients >65 years with chronic limb threatening ischemia, requiring revascularization by implementing a multicomponent multidisciplinary prehabilitation program.
Study objective
Our hypothesis is that by implementing the prehabilitation program, the rate of delirium will be decreased from 18% to 9%.
Study design
Preoperative, admission, 6 months, 12 months
Intervention
Prehabilitation program. Participants will be screened by a nurse practitioner, physiotherapist and dietician. In case of criteria for frailty (as described in ‘appendix’), a geriatrician will perform a comprehensive geriatric assessment (CGA). Depending on this baseline analysis, patients may receive iron infusion and/or vitamin supplementation, recommendations concerning daily exercise and dietary supplements and guidance in reducing alcohol and/or nicotine use. They are asked to keep track of their activities in a daily diary
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Aged 65 years or older
- All genders
- All ethnicities
- Diagnosis of CLTI (Chronic Limb Threatening Ischemia), based on either:
o Anamnestic complaints of ischemic rest pain or night pain
o (Minor) tissue loss, non-healing ulcer and/or focal gangrene with diffuse pedal ischemia[11]
o Impaired perfusion, quantified by a flat or barely pulsatile ankle or metatarsal PVR (pulse volume recording), a low resting ankle pressure, a low ankle brachial index and/or a low toe pressure.
- Indication and informed consent to undergo either endovascular or surgical treatment
- No need to start treatment earlier then 3 weeks, counting from the moment of diagnosis
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Dementia according to DSM-V
- Inability to complete questionnaires, due to either lingual or cognitive incompetence.
- Need for urgent surgery (<3 weeks)
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL9380 |
| Other | MEC-U : W21.061 |