An observational study in Coronary Artery Disease, sponsored by Elzem SEN. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Elzem SEN · Observational
This study aims to evaluate the relationship between intraoperative pulse pressure variation (PPV) and postoperative lactate clearance in adult patients undergoing elective cardiac surgery. Intraoperative PPV values will be recorded, and blood lactate levels will be measured at admission to the intensive care unit and at 6 and 12 hours postoperatively. The study will investigate whether intraoperative PPV is associated with postoperative lactate clearance. This is a prospective observational study, and no additional interventions will be performed beyond routine clinical care.
This prospective observational cohort study will be conducted in adult patients aged 18-80 years undergoing elective coronary artery bypass graft surgery at Gaziantep University Hospital.
Intraoperative pulse pressure variation (PPV) will be recorded during surgery. Blood lactate levels will be measured at admission to the intensive care unit (0 hours) and at 6 and 12 hours postoperatively to assess lactate clearance.
The primary objective is to evaluate the relationship between intraoperative PPV and postoperative lactate clearance. The study will also explore the association between PPV and postoperative lactate clearance categories.
Patients with conditions that may affect the reliability of PPV measurements, including cardiac arrhythmias, spontaneous breathing, low tidal volume ventilation, and severe aortic regurgitation, will be excluded. Emergency surgeries and cases with missing essential hemodynamic or lactate data will also be excluded.
All measurements will be obtained as part of routine clinical care. No additional invasive procedures or study-specific interventions will be performed.
5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.
This study's planned enrollment of 100 is below the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Elzem SEN is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study population will consist of adult patients aged 18-80 years undergoing elective coronary artery bypass graft surgery at Gaziantep University Hospital. Eligible patients will receive invasive arterial blood pressure monitoring and mechanical ventilation during surgery and will be admitted to the intensive care unit postoperatively. Patients meeting the inclusion and exclusion criteria will be consecutively enrolled. Intraoperative pulse pressure variation and postoperative blood lactate concentrations will be recorded as part of routine clinical 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:
Adults aged 18-80 years undergoing elective coronary artery bypass graft surgery who meet the study eligibility criteria. Intraoperative pulse pressure variation and postoperative lactate levels will be assessed.
Other: No Study-Specific Intervention
This is a prospective observational study. No study-specific intervention will be performed. All measurements will be obtained as part of routine clinical care.
Association Between Intraoperative Pulse Pressure Variation and 12-Hour Postoperative Lactate Clearance
The association between intraoperative pulse pressure variation (PPV) and postoperative lactate clearance at 12 hours after admission to the intensive care unit will be evaluated. Lactate clearance will be calculated as the percentage decrease in blood lactate concentration from ICU admission to 12 hours postoperatively.
Time frame: From ICU admission to 12 hours postoperatively
6-Hour Postoperative Lactate Clearance
Percentage change in blood lactate concentration from admission to the intensive care unit to 6 hours postoperatively. Lactate clearance will be calculated as \[(initial lactate - 6-hour lactate) / initial lactate\] × 100.
Time frame: From ICU admission to 6 hours postoperatively
Postoperative Lactate Clearance Categories
Patients will be categorized according to postoperative lactate clearance as ≥20% or \<20%, and the relationship between intraoperative pulse pressure variation and these categories will be evaluated.
Time frame: 12 hours postoperatively
Plan to share: No — Individual participant data will not be shared with other researchers. Only aggregate study results may be reported in scientific publications. No individual-level data sharing is planned.
Started Oct 2026 (actual). Primary completion is estimated for Apr 2027, 5 months after the start.
Of 726 non-industry observational studies under Coronary Artery Disease, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 122. This study's planned 5 months is below that.
Counting every sponsor, half of 857 studies reached it within 43 months; a quarter within 22 and three quarters within 88.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Elzem SEN