- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04771364
Impact of "ASAP" Multidisciplinary Optimization Care Protocol on Clinical Outcome in Elderly Inpatients for Hip Fracture
Impact of "ASAP" Multidisciplinary Optimization Care Protocol on Clinical Outcome in Elderly Inpatients for Hip Fracture: Retrospective Cohort Study
Study Overview
Detailed Description
Retrospective double cohort analysis for ASA physical status 1, 2 and 3 elderly patients >65 years old, scheduled to undergo surgery for hip fracture between January 1st 2017 and December 31st 2022.
The investigator want to confirm the better outcome on 30-days mortality after surgery in patients where the ASAP protocol was applied, starting from 1 January 2020.
ASAP protocol follow the latest international guidelines about hip fracture in elderly patient. The investigator focuses the research about the impact of ASAP protocol on clinical outcome: geriatrician's advice, impact of loco-regional techniques on intra-operative and postoperative pain control, chronic pharmacological therapy's adaptation and 30-days postoperative mortality.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Liège, Belgium, 4000
- CHU de Liège
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Over 65 years old patients with hip fractures between January 1st 2017 and December 31th 2022
Exclusion Criteria:
- Fracture without indication for surgery
- Death before surgery
- Intensive care's or polytrauma patients (> 2 fracture sites) or under pharmacological coma needed before and after surgery.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Standard care
Patients aged >65 years old scheduled for hip fracture between January 1st 2017 and December 31th 2019. Standard anesthesiology cares were performed, as usual in our hospital institution. |
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ASAP cohort
Patients aged >65 years old scheduled for hip fracture between January 1st 2020 and December 31th 2022. Standard anesthesiology cares were performed, as usual in our hospital institution, but the investigator focused the attention on these cares' adaptation: early geriatrician's advice, prefer locoregional anesthesia techniques where possible, early surgical therapy and medical adaptation on chronic therapy. |
Early geriatrician's advice, prefer locoregional anesthesia techniques where possible, early surgical therapy and medical adaptation on chronic patient's therapy (in particular with regard to sedative, anticholinergic and psychotropic drugs).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative complications
Time Frame: 7 days
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Neurological, cardiovascular, pulmonary, renal, infectious and gastrointestinal complications after surgery.
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7 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days of hospitalisation
Time Frame: 30 days
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Total hospitalisation days
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30 days
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30-days postoperative mortality
Time Frame: 30 days
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Mortality 1 month after surgery
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30 days
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Borges FK, Bhandari M, Patel A, Avram V, Guerra-Farfan E, Sigamani A, Umer M, Tiboni M, Adili A, Neary J, Tandon V, Sancheti PK, Lawendy A, Jenkinson R, Ramokgopa M, Biccard BM, Szczeklik W, Wang CY, Landoni G, Forget P, Popova E, Wood G, Nabi Nur A, John B, Sleczka P, Feibel RJ, Balaguer-Castro M, Deheshi B, Winemaker M, de Beer J, Kolesar R, Teixidor-Serra J, Tomas-Hernandez J, McGillion M, Shanthanna H, Moppett I, Vincent J, Pettit S, Harvey V, Gauthier L, Alvarado K, Devereaux PJ. Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients. BMJ Open. 2019 May 1;9(4):e028537. doi: 10.1136/bmjopen-2018-028537.
- Matsuo M, Yamagami T, Higuchi A. Impact of age on postoperative complication rates among elderly patients with hip fracture: a retrospective matched study. J Anesth. 2018 Jun;32(3):452-456. doi: 10.1007/s00540-018-2494-8. Epub 2018 Apr 16.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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