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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03382054
Other study ID # FrailAmb II
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2016
Est. completion date December 31, 2022

Study information

Verified date June 2023
Source Charite University, Berlin, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Frailty is prevalent in older adults and may be a better predictor of post-operative morbidity and mortality than chronological age. Preoperative risk factors and physiological reserves were assessed on patients more than 70 years old who are scheduled for surgery under general or regional anesthesia. The aim of this retrospective analysis was to examine the impact of relevant geriatric assessments on adverse outcomes in older surgical patients.


Description:

The goal of this study is to analyze the effect of frailty status on postoperative outcomes. These include postoperative complications (only ICD-10 coded diagnoses), length of hospitalization (ward/ICU), disposition, and survival. The project will also attempt to find synergism between a positive frailty status and common medical conditions (e.g. diabetes, congestive heart failure, coronary artery disease, dementia, and kidney disease), as well as anesthesiological and surgical processes (e.g. duration and type of anesthesia, surgical risk, and surgical discipline). Different assessment tools will be analyzed regarding their predictive power and clinical practicability. This should help improve preoperative risk assessment and allow for the multidimensional (physical, cognitive, social) identification of relevant frailty characteristics in the perioperative setting. All outcome parameters, including admission and discharge periods, will be collected using coded information from our hospital database. There will be no follow-up measurements after hospital discharge.


Recruitment information / eligibility

Status Completed
Enrollment 25000
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility Inclusion Criteria: - Male and female patients with age 70 years and above scheduled for surgery in the Department of Anesthesiology and Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin Berlin

Sponsors (1)

Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative complications ICD-10 coded diagnoses for the hospitalization 06/2016-12/2022
Secondary Duration of Hospital stay 06/2016-12/2022
Secondary Duration of Intensive Care Unit Stay 06/2016-12/2022
Secondary Procedures The procedures are measured regarding the following practices: anesthesiological, surgical, physiotherapeutic, social, cognitive, therapeutic, behavioral 06/2016-12/2022
Secondary Morbidity 06/2016-12/2022
Secondary Ventilation Ventilation is measured in hours. 06/2016-12/2022
Secondary Requirements for intensive care unit 06/2016-12/2022
Secondary Intensive care unit scores 06/2016-12/2022
Secondary Disease severity 06/2016-12/2022
Secondary Postoperative Delirium Delirium is measured with validated delirium scores. 06/2016-12/2022
Secondary Mortality Mortality is measured in hospital. 06/2016-12/2022
Secondary Medical costs Costs incurred during hospitalization 06/2016-12/2022
Secondary Physiotherapy Physiotherapy is measured by Physiotherapists support. 06/2016-12/2022
Secondary Nutritional therapy 1 Nutritional consultations 06/2016-12/2022
Secondary Nutritional therapy 2 Feeding 06/2016-12/2022
Secondary Post - intensive care syndrome Post - Intensive care syndrome is measured by a cluster of symptoms that are unique to the Intensive care unit environment. 06/2016-12/2022
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