FrailtyNCT03382054
Frailty and Post-operative Complications in Older Surgical Patients: The Implication of Frailty and Preoperative Risk Assessment
An observational study of Frailty and Surgery, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty, Surgery, Older Patients
- How many people
- 25,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2016to 31 Dec 2022
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Male and female patients with age 70 years and above scheduled for surgery
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin
Berlin, 13353
About this study
Official title: Frailty and Post-operative Complications in Older Surgical Patients: The Implication of Frailty and Preoperative Risk Assessment - A Retrospective Analysis
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.
Read the detailed 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.
- Conditions
- Frailty, Surgery, Older Patients
- Medical subject headings
- 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 |
|---|---|---|
| Older robust surgical patients | Male and female patients with age 65 years and above scheduled for surgery, which are robust according to Fried's Modified Frailty Score. | |
| Older pre-frail surgical patients | Male and female patients with age 65 years and above scheduled for surgery, which are pre-frail according to Fried's Modified Frailty Score. | |
| Older frail surgical patients | Male and female patients with age 65 years and above scheduled for surgery, which are frail according to Fried's Modified Frailty Score. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
ICD-10 coded diagnoses for the hospitalization
Measured: 06/2016-12/2022
Secondary outcomes (15)
Duration of Hospital stay
Measured: 06/2016-12/2022
Duration of Intensive Care Unit Stay
Measured: 06/2016-12/2022
Procedures
The procedures are measured regarding the following practices: anesthesiological, surgical, physiotherapeutic, social, cognitive, therapeutic, behavioral
Measured: 06/2016-12/2022
Morbidity
Measured: 06/2016-12/2022
Ventilation
Ventilation is measured in hours.
Measured: 06/2016-12/2022
Requirements for intensive care unit
Measured: 06/2016-12/2022
Intensive care unit scores
Measured: 06/2016-12/2022
Disease severity
Measured: 06/2016-12/2022
Postoperative Delirium
Delirium is measured with validated delirium scores.
Measured: 06/2016-12/2022
Mortality
Mortality is measured in hospital.
Measured: 06/2016-12/2022
Medical costs
Costs incurred during hospitalization
Measured: 06/2016-12/2022
Physiotherapy
Physiotherapy is measured by Physiotherapists support.
Measured: 06/2016-12/2022
Nutritional therapy 1
Nutritional consultations
Measured: 06/2016-12/2022
Nutritional therapy 2
Feeding
Measured: 06/2016-12/2022
Post - intensive care syndrome
Post - Intensive care syndrome is measured by a cluster of symptoms that are unique to the Intensive care unit environment.
Measured: 06/2016-12/2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2017
- Study start1 Jun 2016
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03382054
- Sponsor's protocol ID
- FrailAmb II
- Status last verified
- Jun 2023
- First submitted
- 11 Dec 2017
- Last updated
- 15 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty and Post-operative Complications in Older Surgical Patients: The Implication of Frailty and Preoperative Risk Assessment - A Retrospective Analysis
- ClinicalTrials.gov ID
- NCT03382054
- Acronym / sponsor ID
- FrailAmb II
- Conditions
- Frailty, Surgery, Older Patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,000 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 22 Dec 2017 (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.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Older robust surgical patients | – | –Male and female patients with age 65 years and above scheduled for surgery, which are robust according to Fried's Modified Frailty Score. |
| Older pre-frail surgical patients | – | –Male and female patients with age 65 years and above scheduled for surgery, which are pre-frail according to Fried's Modified Frailty Score. |
| Older frail surgical patients | – | –Male and female patients with age 65 years and above scheduled for surgery, which are frail according to Fried's Modified Frailty Score. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Male and female patients with age 70 years and above scheduled for surgery
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (0 listed)
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
Postoperative complications
Time frame: 06/2016-12/2022
ICD-10 coded diagnoses for the hospitalization
15 secondary outcomes
Duration of Hospital stay
Time frame: 06/2016-12/2022
Duration of Intensive Care Unit Stay
Time frame: 06/2016-12/2022
Procedures
Time frame: 06/2016-12/2022
Morbidity
Time frame: 06/2016-12/2022
Ventilation
Time frame: 06/2016-12/2022
Requirements for intensive care unit
Time frame: 06/2016-12/2022
Intensive care unit scores
Time frame: 06/2016-12/2022
Disease severity
Time frame: 06/2016-12/2022
Postoperative Delirium
Time frame: 06/2016-12/2022
Mortality
Time frame: 06/2016-12/2022
Medical costs
Time frame: 06/2016-12/2022
Physiotherapy
Time frame: 06/2016-12/2022
Nutritional therapy 1
Time frame: 06/2016-12/2022
Nutritional therapy 2
Time frame: 06/2016-12/2022
Post - intensive care syndrome
Time frame: 06/2016-12/2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Claudia Spies, MD, Prof. study director
Charite University, Berlin, Germany
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 Frailty and Surgery, run by Charite University, Berlin, Germany 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 1 inclusion and 0 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: finished, as of the sponsor's last update on 15 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: 06/2016-12/2022). 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 15 Jun 2023.