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PETRI: Prehabilitation in the Elderly with chronic limb Threatening Ischemia

Prehabilitation for preventing delirium in the elderly with chronic limb threatening ischemia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON28123
Enrollment
170
Registered
2021-03-29
Start date
2021-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Limb Threatening Ischemia (CLTI)

Interventions

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

Sponsors

Prof. dr. L. van der Laan
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
Postoperative delirium

Secondary

MeasureTime frame
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.

Contacts

Public ContactAnne Meulenbroek

Amphia Ziekenhuis

AMeulenbroek1@amphia.nl0765953157

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)