Coronary Artery DiseaseNCT07871188
Association Between Intraoperative Pulse Pressure Variation and Postoperative Lactate Clearance in Cardiac Surgery
An observational study of Coronary Artery Disease, run by Elzem SEN at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the relationship between intraoperative pulse pressure variation (PPV) and postoperative lactate clearance in adult patients undergoing elective cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- No Study-Specific Intervention
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Oct 2026to 15 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adults aged 18-80 years.
- Patients undergoing elective coronary artery bypass graft (CABG) surgery.
- Patients receiving invasive arterial blood pressure monitoring and mechanical -ventilation during surgery.
- Patients planned for postoperative admission to the intensive care unit.
- Patients whose informed consent has been obtained.
Who cannot join
- Patients with cardiac arrhythmias that may interfere with PPV measurement, such as atrial fibrillation.
- Patients with severe aortic regurgitation.
- Patients undergoing emergency cardiac surgery.
- Patients receiving off-pump CABG.
- Patients requiring spontaneous breathing or low tidal volume ventilation (<6 mL/kg) during PPV measurement.
- Patients with missing or insufficient intraoperative hemodynamic or postoperative lactate measurements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Gaziantep University Hospital
Gaziantep
ELZEM ŞEN, MD, +90 532 784 2151, drelzemsen@gmail.com
About this study
Official title: Evaluation of the Relationship Between Intraoperative Pulse Pressure Variation and Postoperative Lactate Clearance in Patients Undergoing Cardiac Surgery
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.
Read the detailed description
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.
- Conditions
- Coronary Artery Disease
- Being tested
- No Study-Specific Intervention
- Keywords
- Pulse Pressure Variation, PPV, Lactate Clearance, Cardiac Surgery, Coronary Artery Bypass Graft, Postoperative Lactate
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Study-Specific InterventionOther
This is a prospective observational study. No study-specific intervention will be performed. All measurements will be obtained as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Elective CABG Cohort | 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. Receives: Other: No Study-Specific Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From ICU admission to 12 hours postoperatively
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start2 Oct 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion15 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elzem SEN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elzem SEN, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871188
- Sponsor's protocol ID
- 2026/316
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 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. Only aggregate study results may be reported in scientific publications. No individual-level data sharing is planned.
Publications
Zhou X, Pan W, Chen B, Xu Z, Pan J. Predictive performance of dynamic arterial elastance for arterial pressure response to fluid expansion in mechanically ventilated hypotensive adults: a systematic review and meta-analysis of observational studies. Ann Intensive Care. 2021 Jul 31;11(1):119. doi: 10.1186/s13613-021-00909-2.
PubMed 34331607Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
PubMed 20179283Ranucci M, De Toffol B, Isgro G, Romitti F, Conti D, Vicentini M. Hyperlactatemia during cardiopulmonary bypass: determinants and impact on postoperative outcome. Crit Care. 2006;10(6):R167. doi: 10.1186/cc5113.
PubMed 17134504
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Intraoperative Pulse Pressure Variation and Postoperative Lactate Clearance in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT07871188
- Acronym / sponsor ID
- 2026/316
- Conditions
- Coronary Artery Disease
- Keywords
- Pulse Pressure Variation, PPV, Lactate Clearance, Cardiac Surgery, Coronary Artery Bypass Graft, Postoperative Lactate
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Elzem SENUniversity, hospital or other
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 15 Apr 2027 (estimated)
- First posted
- 13 Oct 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective CABG Cohort | – | Other: No Study-Specific InterventionAdults 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- Adults aged 18-80 years.
- Patients undergoing elective coronary artery bypass graft (CABG) surgery.
- Patients receiving invasive arterial blood pressure monitoring and mechanical -ventilation during surgery.
- Patients planned for postoperative admission to the intensive care unit.
- Patients whose informed consent has been obtained.
Key exclusion criteria (6 listed)
- Patients with cardiac arrhythmias that may interfere with PPV measurement, such as atrial fibrillation.
- Patients with severe aortic regurgitation.
- Patients undergoing emergency cardiac surgery.
- Patients receiving off-pump CABG.
- Patients requiring spontaneous breathing or low tidal volume ventilation (<6 mL/kg) during PPV measurement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Study-Specific InterventionThis is a prospective observational study. No study-specific intervention will be performed. All measurements will be obtained as part of routine clinical care. | Other | Elective CABG Cohort |
Primary outcome
Association Between Intraoperative Pulse Pressure Variation and 12-Hour Postoperative Lactate Clearance
Time frame: From ICU admission to 12 hours postoperatively
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.
2 secondary outcomes
6-Hour Postoperative Lactate Clearance
Time frame: From ICU admission to 6 hours postoperatively
Postoperative Lactate Clearance Categories
Time frame: 12 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 34331607Zhou X, Pan W, Chen B, Xu Z, Pan J. Predictive performance of dynamic arterial elastance for arterial pressure response to fluid expansion in mechanically ventilated hypotensive adults: a systematic review and meta-analysis of observational studies. Ann Intensive Care. 2021 Jul 31;11(1):119. doi: 10.1186/s13613-021-00909-2.
- Background: PubMed 20179283Jones AE, Shapiro NI, Trzeciak S, Arnold RC, Claremont HA, Kline JA; Emergency Medicine Shock Research Network (EMShockNet) Investigators. Lactate clearance vs central venous oxygen saturation as goals of early sepsis therapy: a randomized clinical trial. JAMA. 2010 Feb 24;303(8):739-46. doi: 10.1001/jama.2010.158.
- Background: PubMed 17134504Ranucci M, De Toffol B, Isgro G, Romitti F, Conti D, Vicentini M. Hyperlactatemia during cardiopulmonary bypass: determinants and impact on postoperative outcome. Crit Care. 2006;10(6):R167. doi: 10.1186/cc5113.
- Individual participant dataSharing planned: 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.
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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.
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 Coronary Artery Disease, run by Elzem SEN 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 13 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ELZEM ŞEN, MD (+905327842151, drelzemsen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Intraoperative Pulse Pressure Variation and 12-Hour Postoperative Lactate Clearance (time frame: From ICU admission to 12 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07871188, which also lists 3 linked publications.
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 13 Oct 2026.