An observational study in Heart Valve Diseases, Aortic Diseases and Myocardial Ischemia, sponsored by Muhammet Talha Ceran, MD. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Muhammet Talha Ceran, MD · Observational
This single-center, prospective, observational cohort study quantifies the effective myocardial protection window of Del Nido cardioplegia during adult open-heart surgery performed under cardiopulmonary bypass (CPB) and aortic cross-clamp (ACC). Without altering routine care, time-stamped high-sensitivity cardiac troponin (hs-cTn) measurements will be obtained at predefined intraoperative and early postoperative intervals to identify the inflection ("change-point") at which biochemical evidence of ischemic injury begins to rise. Eighty adults undergoing elective valve and/or thoracic aortic procedures with Del Nido cardioplegia will be enrolled. The primary endpoint is the intraoperative hs-cTn change-point time referenced to ACC. Secondary endpoints include associations between change-point and ACC duration, the presence/timing of any re-dose, and early clinical outcomes (e.g., low cardiac output syndrome, maximum VIS in the first 24 h, new arrhythmia or pacemaker need, acute kidney injury by KDIGO, ventilation hours, ICU/hospital length of stay, 30-day MACE and mortality). All cardioplegia choices (dose, route, temperature, re-dose decisions) remain per standard practice; no experimental therapy is administered. Risks are minimal and limited to small-volume blood sampling coordinated with routine draws.
Background and Rationale Del Nido cardioplegia is widely used in adult valve/aortic surgery to permit prolonged single-dose electrical arrest. The effective protection duration likely varies with patient and procedural factors (e.g., LV function, temperature, hemodilution, surgical complexity, antegrade/retrograde delivery). Many centers empirically re-dose around 60-90 minutes; however, this window may not be optimal for every case. The current study quantifies the protection window by coupling routine care with dense, time-stamped hs-troponin sampling.
Design and Setting Prospective, single-center, observational cohort conducted at Necmettin Erbakan University, Department of Cardiovascular Surgery (Türkiye).
Population Adults 18-80 years scheduled for elective valve and/or thoracic aortic surgery under CPB with ACC in which Del Nido cardioplegia is used per institutional routine. Key exclusions include isolated or CABG-dominant procedures, redo sternotomy, emergency/salvage or preoperative shock, IABP/ECMO, LVEF \<35%, eGFR \<45 mL/min/1.73 m², significant pulmonary or hepatic disease, major coagulopathy, active infection/sepsis or endocarditis, pregnancy, and preoperative troponin elevation.
Interventions None. Cardioplegia content, dose, route (antegrade/retrograde/combined), temperature, and re-dose decisions are entirely per standard practice at the discretion of the surgical/anesthesia/perfusion team. No experimental therapy is administered.
Sampling Schedule (Biomarkers) Preoperative baseline hs-cTn; intraoperative sampling referenced to ACC at 0, 30, and 60 minutes, then intensified at 75, 90, 105, and 120 minutes. If a re-dose is administered, additional samples at pre-re-dose and +15/+30/+45/+60 minutes. Postoperative hs-cTn at approximately 6, 24, and 48 hours. Intraoperative blood is obtained preferably from the venous reservoir or existing central lines. Each draw \~3-5 mL; total additional volume \~30-40 mL. Exploratory CK-MB may be recorded where available.
Outcomes Primary outcome: intraoperative hs-cTn change-point time (minutes from ACC) identified by segmented (piecewise) trend analysis indicating the earliest sustained acceleration compatible with evolving ischemic injury.
Key secondary outcomes: (i) association between change-point and ACC duration; (ii) presence/timing of Del Nido re-dose and biochemical response to re-dose (slope change pre/post); (iii) early clinical outcomes including low cardiac output syndrome, maximum VIS in the first 24 h, new arrhythmia or pacemaker need, acute kidney injury by KDIGO, ventilation hours, ICU/hospital length of stay, re-exploration/bleeding, infection, 30-day MACE, and 30-day all-cause mortality.
Statistical Plan (Summary) Individual time series will be analyzed using segmented (piecewise) regression and/or change-point detection methods. Group-level estimates (mean protection window and variance) will be obtained via mixed-effects change-point models. Associations with durations (ACC, CPB), re-dose timing, and outcomes will use linear/quantile regression and logistic/Poisson/negative binomial models as appropriate. Missing data will be handled per predefined rules and, if needed, multiple imputation. Target enrollment is 80 participants, anticipated to provide \~80% power at α=0.05 to detect a clinically meaningful change-point and slope shift in hs-troponin trajectories.
Safety and Data Handling Risk is minimal and limited to low-volume blood sampling aligned with routine care; no experimental treatment is given. Data are recorded on standardized case report forms and stored in secure, de-identified systems compliant with local regulations. Serious adverse events are reported per institutional/authority requirements.
Significance By quantifying the actual protection window and its variability, the study is designed to inform more rational-potentially individualized-re-dose timing for Del Nido cardioplegia, aiming to reduce both under-protection (late re-dose) and workflow disruption (unnecessary early re-dose).
552 studies on the registry are indexed under Heart Valve Diseases; 162 are open to participants now.
This study's enrollment of 80 is below the median of 300 across 226 observational studies indexed under Heart Valve Diseases.
Browse Heart Valve Diseases studies →This is the only study on the registry with Muhammet Talha Ceran, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Single-center, tertiary academic cardiovascular surgery service at Necmettin Erbakan University Meram Medical Faculty Hospital (Konya, Türkiye). Consecutive adults (18-80 years) undergoing elective valve and/or thoracic aortic surgery with cardiopulmonary bypass and aortic cross-clamping, in whom Del Nido cardioplegia is used as part of routine care, are screened and, if eligible, approached for written informed consent. Approximately 80 participants are enrolled and followed through the index hospitalization; 30-day outcomes are abstracted from the medical record/standard follow-up. Observational cohort; no randomization; all treatment decisions per usual care.
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.
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.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
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.
Adults undergoing elective valve and/or thoracic aortic surgery under CPB with ACC in which Del Nido cardioplegia is used per routine practice. No experimental therapy; only study-specific blood sampling for hs-troponin at predefined times.
Intraoperative hs-troponin change-point time (minutes from ACC)
For each participant, serial hs-cTn values obtained at ACC 0/30/60/75/90/105/120 minutes (and at re-dose pre/+15/+30/+45/+60 when applicable) will be modeled with segmented (piecewise) regression. The change-point is defined as the earliest time with a statistically significant increase in slope indicating evolving myocardial injury. Unit: minutes; lower values reflect earlier loss of protection.
Time frame: From aortic cross-clamp (ACC) application to 120 minutes intraoperatively; if a re-dose is given, up to 60 minutes after the re-dose within the same operation.
Biochemical response to re-dose (slope change in hs-troponin)
Within-subject comparison of hs-cTn trajectory slope before vs after re-dose using segmented regression. Metric: difference in slopes (ng/L per minute).
Time frame: From re-dose (time 0) to +60 minutes intraoperatively.
Peak postoperative hs-troponin (0-48 h)
Maximum measured hs-cTn (ng/L) within the first 48 hours after surgery.
Time frame: From end of surgery to 48 hours postoperatively (samples ~6, 24, 48 h).
Low Cardiac Output Syndrome (LCOS) within 24 hours
LCOS defined as any of the following: (a) maximum vasoactive-inotropic score (VIS) ≥15 for ≥2 consecutive hours; or (b) initiation of mechanical circulatory support (IABP/ECMO); or (c) cardiac index \<2.2 L/min/m² with clinical hypoperfusion requiring inotrope/vasopressor escalation. Outcome reported as proportion of participants meeting criteria.
Time frame: First 24 postoperative hours.
30-day major adverse cardiovascular events (MACE)
Composite of all-cause death, non-fatal myocardial infarction (per institutional cardiac-surgery definition), and stroke/TIA. Reported as proportion of participants; components also summarized separately.
Time frame: 30 days after surgery
Association between change-point time and ACC duration
Linear/quantile regression of change-point time (min) on ACC duration (min). Effect size reported as β per 10-min increase in ACC with 95% CI.
Time frame: Intraoperative (from ACC on to 120 min; re-dose window as applicable)
Immediate reperfusion arrhythmia after ACC removal
Incidence of VF/VT requiring defibrillation or temporary pacing. Reported as proportion; association with change-point explored.
Time frame: From ACC removal to 30 minutes after reperfusion
Plan to share: Yes — De-identified individual participant data underlying the primary and key secondary outcomes (time-stamped hs-troponin values, basic demographics, operative variables, and early postoperative outcomes). Data will be shared in compliance with local regulations (e.g., KVKK) and institutional policies.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Available beginning 6-12 months after the primary publication (or within 12 months after last-patient-last-visit if no publication) and will remain available for 5 years.
Access criteria: Qualified researchers may request access by submitting a brief proposal to the Central Contact. Requests will be reviewed by the study investigators and the institutional Data Access Committee. Upon approval and execution of a Data Use Agreement (non-reidentification, secure storage, academic use only, citation/acknowledgment, and data destruction at project end), de-identified IPD and supporting documents will be transferred via secure link. Central Contact: Muhammet Talha Ceran, MD - mtceran@gmail.com
Data sharing details ↗ · hastane.erbakan.edu.tr
Ran from Nov 2025 to primary completion in Jan 2026, 2 months.
Of 95 non-industry observational studies under Heart Valve Diseases, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 212. This study's 2 months is below that.
Counting every sponsor, half of 115 studies reached it within 67 months; a quarter within 23 and three quarters within 212.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.