- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07603622
Perioperative Predictive Value of Physical Activity on Short- and Long-term Morbidity and Mortality (PeriopPrePA)
Over 300 million surgeries are performed globally every year. Complications after surgery - infections, cardiovascular conditions, postoperative pulmonary complications and renal impairment - affect survival and quality of life.
Age and co-morbidity are unmodifiable factors, contributing to increased risk of these perioperative complications. However, a modifiable risk factor is physical activity. This study aims to test if self reported physical activity has added predicted value, beyond established risk factors, for predicting perioperative morbidity and mortality.
Study Overview
Status
Conditions
Detailed Description
Research question: This cohort study investigates if higher levels of self reported physical activity at preoperative assessment has added predicted value, beyond established risk factors, for predicting perioperative morbidity and mortality.
Background: Previous studies of perioperative outcomes in high-income countries indicate that close to 20% had complications within 30 days after surgery, and that around 3% died within 1 yr after surgery. In multiple studies, postoperative complications massively increase risk of 1yr mortality. Whilst perioperative complications are under-reported, they affect length of stay and days at home up to 30 days after surgery (DAH30). DAH30 is a validated, patient-centered outcome measure with prognostic importance due to high sensitivity to changes in surgical risks and the impact of surgical complications. DAH365, the days at home up to one year after surgery, is also an important patient-centered outcome measure.
Data collection: Age, sex, body mass index, co-morbid conditions (using ICD-codes and reported medication) as well as American Society of Anesthesiologists (ASA) physical status classification will be recorded. The predictor of interest: the Metabolic Equivalent of Task Score (MET-score), reported in the electronic health record by the attending anesthesiologist based on patient history in conjunction with the preoperative assessment.
Analysis: The MET-score is the predictor of interest. The potential added predictive value of the MET-score, will be assed using a machine learning approach, by comparing it to other established predictive factors.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Max Bell, MD, PhD
- Phone Number: +46708278533
- Email: max.bell@regionstockholm.se
Study Contact Backup
- Name: Arman Valadkhani, MD, PhD
- Phone Number: +46812370000
- Email: arman.valadkhani@regionstockholm.se
Study Locations
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-
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Stockholm, Sweden
- Recruiting
- Karolinska Institutet
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Contact:
- Max Bell, MD, PhD
- Email: max.bell@regionstockholm.se
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Principal Investigator:
- Max Bell, MD, PhD
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (equal to or over 18 years) undergoing elective non-cardiac surgery at the two study sites, Karolinska University Hospital Solna and Karolinska University Hospital Huddinge
Exclusion Criteria:
- Patients under the age of 18, transplant, day surgery, acute surgery, anesthesia monitoring, brachy therapy and gamma knife interventions. In case of multiple surgeries, only the first will be included.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mortality
Time Frame: [Time Frame: Mortality will be recorded at 30, 60, 90 and 365 days after index surgery]
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Death within the time frames described below
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[Time Frame: Mortality will be recorded at 30, 60, 90 and 365 days after index surgery]
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
DAH30 (Days At Home alive at 30 days)
Time Frame: 30 days after index surgery
|
DAH30: Patients who are hospitalized for 14 days postoperatively but are alive on day 30 will have DAH30=16.
Patients who are hospitalized for five days, then discharged, but return after 10 days for an additional 11-day stay, will have DAH30=14.
Anyone who dies within 30 days will have DAH30=0.
This outcome measure is validated in several studies and has a significant advantage in that it correlates well with complications, even better than length of stay (LOS).
|
30 days after index surgery
|
|
DAH365 (Days At Home alive at 365 days)
Time Frame: 365 days after index surgery
|
DAH365: See above
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365 days after index surgery
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PeriopPrePA Karolinska
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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