Pancreas DiseaseNCT07778914
Cardiac Cycle Efficiency and Postoperative Troponin
An observational study of Pancreas Disease and Troponin T, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
Trial summary
Knowing how intraoperative anesthesia management and cardiac cycle monitoring affect postoperative cardiac outcomes in patients undergoing pancreatic surgery can help develop a protocol for future cases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pancreas Disease, Troponin T, Hemodynamic Monitoring
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Sep 2025to 15 Jul 2026
- How long will I take part?
- 1 Day
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included high-risk adult patients scheduled to undergo pancreaticoduodenectomy at Istanbul Basaksehir Cam and Sakura City Hospital. Eligible patients were aged ≥65 years or aged ≥45 years with at least one predefined comorbidity associated with increased cardiovascular risk. Patients were prospectively followed from the intraoperative period through the first postoperative morning, with continuous intraoperative hemodynamic monitoring and postoperative high-sensitivity cardiac troponin T (hsTnT) assessment.
Who may be able to join
- Age ≥65 years, or age ≥45 years with at least one predefined comorbidity. Scheduled to undergo pancreaticoduodenectomy.
- Presence of at least one of the following comorbidities in patients aged ≥45 years:
- Diabetes mellitus
- Hypertension
- Coronary artery disease
- Congestive heart failure
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- Moderate-to-severe valvular heart disease
- Peripheral arterial disease
- Moderate-to-severe pulmonary hypertension
- Previous cerebrovascular accident occurring >1 month before surgery
- Previous pulmonary embolism occurring >1 month before surgery
- Provision of written informed consent.
Who cannot join
- Atrial fibrillation on the day of surgery.
- Sepsis on the day of surgery.
- Pulmonary embolism on the day of surgery.
- Pulmonary embolism within the preceding 1 month.
- Acute coronary syndrome within the preceding 1 month.
- Cerebrovascular accident within the preceding 1 month.
Show all 10Show fewer
- Preoperative hsTnT >65 ng/L.
- Glomerular filtration rate <60 mL/min.
- Newly developed postoperative arrhythmia or embolic event that could influence postoperative hsTnT concentrations.
- Planned pancreaticoduodenectomy being abandoned after laparotomy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam and Sakura City Hospital
Istanbul, Istanbul, 34480
About this study
Official title: The Relationship Between Cardiac Cycle Efficiency and Postoperative Troponin Elevation in Patients Undergoing Pancreatic Surgery.
Knowing how intraoperative anesthesia management and cardiac cycle monitoring affect postoperative cardiac outcomes in patients undergoing pancreatic surgery can help develop a protocol for future cases.
Whether cardiac damage following non-cardiac surgery can be prevented and the necessary precautions are not yet clear, and the most important finding when it occurs is elevated troponin levels. This can occur even without ECG changes or chest pain. Prevention could contribute to a reduction in postoperative morbidity and mortality, and a shorter hospital stay.
The primary aim of this study is to evaluate the correlation between the duration of cardiac cycle efficiency remaining below zero and increased troponin levels.
Read the detailed description
In patients undergoing non-cardiac surgery with cardiac risk factors, baseline values for preoperative troponin and pro-BNP are monitored as recommended by guidelines, followed by daily troponin monitoring for at least 3 days. Pancreatic surgeries are classified as high-risk surgeries by relevant guidelines, and cardiac output monitoring is recommended in this patient group with a Class 1A indication and evidence level. In this context, cardiac output monitoring with arterial wave analysis is routinely performed in our clinic, and the relevant parameters are followed. This observational study will examine the correlation between the intraoperative cardiac turnover trend and the highest troponin value within 3 days postoperatively. No specific intervention or protocol will be applied to the patients for this study. Preoperative troponin testing and postoperative troponin monitoring are recommended for patients over 65 years of age undergoing high-risk surgery, and for patients over 45 years of age with cardiac risk factors (history of cerebrovascular events, insulin-dependent diabetes mellitus, history of coronary artery disease, history of heart failure, serum creatinine > 2 mg/dL, high-risk surgery). In general surgery clinics, this monitoring is routinely performed in this patient group, in accordance with the recommendations of relevant guidelines, to reduce perioperative morbidity/mortality.
- Conditions
- Pancreas Disease, Troponin T, Hemodynamic Monitoring, MINS
- Keywords
- pancreatic surgery, troponin T, hemodynamic monitoring, MINS
- Medical subject headings
- Pancreatic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Spearman correlation between cumulative intraoperative duration of CCE < -0.2 and postoperative hsTnT concentration
The primary outcome is the Spearman rank correlation coefficient (r_s) between two measures: (1) cumulative intraoperative duration during which cardiac cycle efficiency (CCE) remains below -0.2, measured in minutes using the MostCare arterial waveform analysis system; and (2) high-sensitivity cardiac troponin T (hsTnT) concentration measured on the first postoperative morning, expressed in ng/L and determined using an electrochemiluminescence immunoassay (Roche Diagnostics). The correlation will quantify the strength and direction of the relationship between cumulative exposure to CCE < -0.2 and postoperative hsTnT concentration.
Measured: From the start of intraoperative hemodynamic monitoring to the first postoperative morning (approximately 24 hours after surgery).
Secondary outcomes (5)
Effective Arterial Elastance (Ea)
Effective arterial elastance (Ea) will be measured intraoperatively as a marker of arterial load. Its relative contribution to cardiac cycle efficiency (CCE) will be evaluated using hierarchical linear mixed-effects modeling. Model fit and the incremental contribution of Ea will be assessed using Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC).
Measured: During surgery.
Total Arterial Impedance (Ztot)
Total arterial impedance (Ztot) will be measured intraoperatively as a marker of arterial load. Its relative contribution to cardiac cycle efficiency (CCE) will be evaluated using hierarchical linear mixed-effects modeling. Model fit and the incremental contribution of Ztot will be assessed using Akaike Information Criterion (AIC) and Bayesian Information Criterion (BIC).
Measured: During surgery.
Cardiac Cycle Efficiency (CCE)
Cardiac cycle efficiency (CCE) will be assessed intraoperatively as a measure of the efficiency of cardiac mechanical work. CCE will be evaluated at predefined intraoperative time points and analyzed using linear mixed-effects modeling.
Measured: During surgery
Stroke Volume (SV)
Stroke volume (SV) will be assessed intraoperatively as a measure of cardiac output per cardiac cycle and evaluated as a hemodynamic determinant of cardiac cycle efficiency using linear mixed-effects modeling.
Measured: During surgery
Maximal Rate of Pressure Rise (dP/dtmax)
The maximal rate of ventricular pressure rise (dP/dtmax) will be assessed intraoperatively as a measure of myocardial contractility and evaluated as a hemodynamic determinant of cardiac cycle efficiency using linear mixed-effects modeling.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start15 Sep 2025
- Primary completion15 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 51 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul Saglik Bilimleri University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taner Abdullah, Istanbul Saglik Bilimleri University
- Investigators
- Hürü Ceren Gökduman, MD, Study chair, Basaksehir Cam ve Sakura State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07778914
- Sponsor's protocol ID
- 09.07.2025.261
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Cardiac Cycle Efficiency and Postoperative Troponin Elevation in Patients Undergoing Pancreatic Surgery.
- ClinicalTrials.gov ID
- NCT07778914
- Acronym / sponsor ID
- 09.07.2025.261
- Conditions
- Pancreas Disease, Troponin T, Hemodynamic Monitoring, MINS
- Keywords
- pancreatic surgery, troponin T, hemodynamic monitoring, MINS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Istanbul Saglik Bilimleri UniversityUniversity, hospital or other
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 15 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 21 Aug 2026 (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.
Knowing how intraoperative anesthesia management and cardiac cycle monitoring affect postoperative cardiac outcomes in patients undergoing pancreatic surgery can help develop a protocol for future cases.
Whether cardiac damage following non-cardiac surgery can be prevented and the necessary precautions are not yet clear, and the most important finding when it occurs is elevated troponin levels. This can occur even without ECG changes or chest pain. Prevention could contribute to a reduction in postoperative morbidity and mortality, and a shorter hospital stay.
The primary aim of this study is to evaluate the correlation between the duration of cardiac cycle efficiency remaining below zero and increased troponin levels.
Detailed description
In patients undergoing non-cardiac surgery with cardiac risk factors, baseline values for preoperative troponin and pro-BNP are monitored as recommended by guidelines, followed by daily troponin monitoring for at least 3 days. Pancreatic surgeries are classified as high-risk surgeries by relevant guidelines, and cardiac output monitoring is recommended in this patient group with a Class 1A indication and evidence level. In this context, cardiac output monitoring with arterial wave analysis is routinely performed in our clinic, and the relevant parameters are followed. This observational study will examine the correlation between the intraoperative cardiac turnover trend and the highest troponin value within 3 days postoperatively. No specific intervention or protocol will be applied to the patients for this study. Preoperative troponin testing and postoperative troponin monitoring are recommended for patients over 65 years of age undergoing high-risk surgery, and for patients over 45 years of age with cardiac risk factors (history of cerebrovascular events, insulin-dependent diabetes mellitus, history of coronary artery disease, history of heart failure, serum creatinine > 2 mg/dL, high-risk surgery). In general surgery clinics, this monitoring is routinely performed in this patient group, in accordance with the recommendations of relevant guidelines, to reduce perioperative morbidity/mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included high-risk adult patients scheduled to undergo pancreaticoduodenectomy at Istanbul Basaksehir Cam and Sakura City Hospital. Eligible patients were aged ≥65 years or aged ≥45 years with at least one predefined comorbidity associated with increased cardiovascular risk. Patients were prospectively followed from the intraoperative period through the first postoperative morning, with continuous intraoperative hemodynamic monitoring and postoperative high-sensitivity cardiac troponin T (hsTnT) assessment.
Key inclusion criteria (12 listed)
- Age ≥65 years, or age ≥45 years with at least one predefined comorbidity. Scheduled to undergo pancreaticoduodenectomy.
- Diabetes mellitus
- Hypertension
- Coronary artery disease
- Congestive heart failure
Key exclusion criteria (10 listed)
- Atrial fibrillation on the day of surgery.
- Sepsis on the day of surgery.
- Pulmonary embolism on the day of surgery.
- Pulmonary embolism within the preceding 1 month.
- Acute coronary syndrome within the preceding 1 month.
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
Spearman correlation between cumulative intraoperative duration of CCE < -0.2 and postoperative hsTnT concentration
Time frame: From the start of intraoperative hemodynamic monitoring to the first postoperative morning (approximately 24 hours after surgery).
The primary outcome is the Spearman rank correlation coefficient (r_s) between two measures: (1) cumulative intraoperative duration during which cardiac cycle efficiency (CCE) remains below -0.2, measured in minutes using the MostCare arterial waveform analysis system; and (2) high-sensitivity cardiac troponin T (hsTnT) concentration measured on the first postoperative morning, expressed in ng/L and determined using an electrochemiluminescence immunoassay (Roche Diagnostics). The correlation will quantify the strength and direction of the relationship between cumulative exposure to CCE < -0.2 and postoperative hsTnT concentration.
5 secondary outcomes
Effective Arterial Elastance (Ea)
Time frame: During surgery.
Total Arterial Impedance (Ztot)
Time frame: During surgery.
Cardiac Cycle Efficiency (CCE)
Time frame: During surgery
Stroke Volume (SV)
Time frame: During surgery
Maximal Rate of Pressure Rise (dP/dtmax)
Time frame: During surgery
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 21 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers.
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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.
Hürü Ceren Gökduman, MD study chair
Basaksehir Cam ve Sakura State Hospital
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 Pancreas Disease and Troponin T, run by Istanbul Saglik Bilimleri University at 1 site in Turkey (Türkiye).
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 12 inclusion and 10 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 21 Aug 2026. 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 Turkey (Türkiye). 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?
Spearman correlation between cumulative intraoperative duration of CCE < -0.2 and postoperative hsTnT concentration (time frame: From the start of intraoperative hemodynamic monitoring to the first postoperative morning (approximately 24 hours after surgery).). 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 21 Aug 2026.