An observational study in Pancreas Disease, Troponin T and Hemodynamic Monitoring, sponsored by Istanbul Saglik Bilimleri University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Istanbul Saglik Bilimleri University · Observational
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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.
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.
184 studies on the registry are indexed under Pancreatic Diseases; 63 are open to participants now.
This study's enrollment of 51 is below the median of 363 across 76 observational studies indexed under Pancreatic Diseases.
Browse Pancreatic Diseases studies →Istanbul Saglik Bilimleri University is the lead sponsor of 60 studies on the registry; 15 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: From the start of intraoperative hemodynamic monitoring to the first postoperative morning (approximately 24 hours after surgery).
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During surgery
Plan to share: No — Individual participant data will not be shared with other researchers.
No publications or documents are linked to this record.
Ran from Sep 2025 to primary completion in Jul 2026, 10 months.
Of 44 observational studies under Pancreatic Diseases, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 119. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Istanbul Saglik Bilimleri University