- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07454564
Preoperative Cardiac Power Output and P-POSSUM Score
Investigation of the Relationship Between Preoperative Cardiac Power Output and P-POSSUM Score
Study Overview
Status
Detailed Description
This is a prospective, observational study designed to evaluate the relationship between preoperative Cardiac Power Output (CPO) and the P-POSSUM risk score in patients aged 65 years and older undergoing abdominal surgery, including both elective and emergency procedures. CPO is a hemodynamic parameter reflecting overall cardiac pumping power and may provide additional physiologic information beyond traditional risk models. P-POSSUM is widely used to estimate postoperative morbidity and mortality based on physiological and operative variables.
Eligible patients will be assessed in the preoperative period. Preoperative CPO will be obtained using non-invasive hemodynamic measurements as part of routine perioperative practice. The P-POSSUM score will be calculated for each patient using standard definitions. Patients will be followed during the postoperative period to document clinical outcomes, including postoperative complications and mortality within the predefined follow-up window, as well as length of hospital stay when available.
The primary objective is to assess the association between preoperative CPO and the P-POSSUM score. Secondary objectives include exploring whether preoperative CPO is associated with postoperative outcomes and whether it may help refine perioperative risk stratification. This study does not involve any investigational treatment; no additional interventions beyond standard clinical care will be performed. All data will be handled in accordance with applicable privacy and confidentiality regulations, and patient identifiers will not be included in the analysis dataset.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Engin Kılınç, medical doctor
- Phone Number: 00 90 332 223 60 00
- Email: enginkilinc96@gmail.com
Study Locations
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-
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Konya, Turkey (Türkiye)
- Recruiting
- Necmettin Erbakan University
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Contact:
- Engin Kılınç, medical doctor
- Phone Number: 00 90 332 223 60 00
- Email: enginkilinc96@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria: Being 65 years of age or older,
- Undergoing abdominal surgery in general surgery practice (including elective and emergency procedures),
- ASA (American Society of Anesthesiologists) class I-III,
- Adequate recording with transthoracic echocardiography,
- Having given informed consent.
Exclusion Criteria:Advanced heart failure with ejection fraction (EF) <30%,
- Severe valvular disease (severe stenosis or insufficiency),
- Unstable coronary artery disease or recent myocardial infarction (within the last 3 months),
- Pulmonary hypertension,
- Severe arrhythmia (uncontrolled atrial fibrillation, ventricular tachycardia, etc.)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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patients aged 65 years and older undergoing abdominal surgery
This cohort consists of patients aged 65 years and older undergoing abdominal surgery, including both elective and emergency procedures.
All participants will undergo preoperative evaluation, including non-invasive measurement of Cardiac Power Output (CPO) and calculation of the P-POSSUM score, as part of routine clinical assessment.
No experimental intervention will be performed in this study, and all patients will receive standard clinical care and follow-up.
Postoperative clinical outcomes will be recorded prospectively.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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30-day postoperative mortality
Time Frame: Up to 30 days after surgery
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All-cause mortality occurring within 30 days after abdominal surgery in patients aged 65 years and older (yes/no).
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Up to 30 days after surgery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative morbidity
Time Frame: Up to 30 days after surgery
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Postoperative morbidity assessed using the Postoperative Morbidity Survey (POMS).
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Up to 30 days after surgery
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Early postoperative morbidity
Time Frame: Postoperative day 3
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Early postoperative morbidity assessed using the Postoperative Morbidity Survey (POMS) on postoperative day 3.
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Postoperative day 3
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: ŞULE ARICAN, Assoc. Prof., Konya Necmettin Erbakan University
- Study Director: Engin Kılınç, Medical Doctor, Konya Necmettin Erbakan University
Study record dates
Study Major Dates
Study Start (Actual)
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
- 2025/5880
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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