Coronary Artery DiseaseNCT07871201
Dynamic Arterial Elastance for Prediction of Vasopressor Requirement After Anesthesia Induction in Elective On-Pump CABG
An observational study of Coronary Artery Disease, run by Elzem SEN at 1 site in Turkey (Türkiye).
Trial summary
This study aims to determine whether dynamic arterial elastance (EaDyn), measured after anesthesia induction, can predict the need for vasopressor treatment in patients undergoing elective on-pump coronary artery bypass graft surgery. EaDyn will be calculated from pulse pressure variation and stroke volume variation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2026to 1 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: Adults aged 18-80 years undergoing elective on-pump coronary artery bypass graft surgery at Gaziantep University Hospital who meet the predefined inclusion and exclusion criteria. Patients will undergo routine anesthesia and surgical management. Hemodynamic parameters will be recorded before anesthesia induction and at 1, 3, and 5 minutes after induction, and vasopressor use will be documented.
Who may be able to join
- Age ≥18 years.
- Patients undergoing elective cardiac surgery with cardiopulmonary bypass (on-pump).
- Patients with arterial catheter monitoring.
- Patients receiving mechanical ventilation.
Who cannot join
- Arrhythmia (e.g., atrial fibrillation).
- Severe aortic regurgitation.
- Spontaneous breathing.
- Low tidal volume.
- Emergency surgery.
- Off-pump cardiac surgery (cardiac surgery performed without cardiopulmonary bypass).
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, +905327842151, drelzemsen@gmail.com
ELZEM ŞEN, MD
About this study
Official title: The Role of Dynamic Arterial Elastance in Predicting Vasopressor Requirement After Anesthesia Induction in Patients Undergoing Elective On-Pump Coronary Artery Bypass Graft Surgery
This study aims to determine whether dynamic arterial elastance (EaDyn), measured after anesthesia induction, can predict the need for vasopressor treatment in patients undergoing elective on-pump coronary artery bypass graft surgery. EaDyn will be calculated from pulse pressure variation and stroke volume variation. Hemodynamic measurements will be recorded before anesthesia induction and at 1, 3, and 5 minutes after induction. The study is prospective and observational, and no additional intervention will be performed as part of the study.
- Conditions
- Coronary Artery Disease
- Being tested
- No intervention
- Keywords
- Dynamic Arterial Elastance, EaDyn, Vasopressor Requirement, Coronary Artery Bypass Greft, CABG, Anesthesia Induction, Pulse Pressure Variation, Stroke Volume Variation
- 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 interventionOther
This is an observational study. No study-specific intervention is assigned to participants. Anesthesia and surgical management will be performed according to routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Elective On-Pump CABG Cohort | Adults aged 18-80 years undergoing elective on-pump coronary artery bypass graft surgery who meet the study eligibility criteria. Hemodynamic parameters will be recorded before and after anesthesia induction, and vasopressor use will be documented. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressor Requirement Within 5 Minutes After Anesthesia Induction
Requirement for administration of any vasopressor after anesthesia induction, recorded as a binary outcome (yes/no). Vasopressor use will be assessed during the post-induction hemodynamic assessment period.
Measured: From anesthesia induction to 5 minutes after induction
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 start1 Oct 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elzem SEN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elzem SEN, University of Gaziantep
- Investigators
- ELZEM ŞEN, MD, Study chair, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07871201
- Sponsor's protocol ID
- 2026/317
- 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. No plan has been established for sharing individual-level participant data beyond the research team. Study results will be reported in aggregate form.
Publications
Bar S, Nguyen M, Abou-Arab O, Dupont H, Bouhemad B, Guinot PG. Dynamic Arterial Elastance Is Associated With the Vascular Waterfall in Patients Treated With Norepinephrine: An Observational Study. Front Physiol. 2021 May 4;12:583370. doi: 10.3389/fphys.2021.583370. eCollection 2021.
PubMed 34017263Zhou 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 34331607Garcia MI, Romero MG, Cano AG, Aya HD, Rhodes A, Grounds RM, Cecconi M. Dynamic arterial elastance as a predictor of arterial pressure response to fluid administration: a validation study. Crit Care. 2014 Nov 19;18(6):626. doi: 10.1186/s13054-014-0626-6.
PubMed 25407570Monge Garcia MI, Gil Cano A, Gracia Romero M. Dynamic arterial elastance to predict arterial pressure response to volume loading in preload-dependent patients. Crit Care. 2011;15(1):R15. doi: 10.1186/cc9420. Epub 2011 Jan 12.
PubMed 21226909
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
- The Role of Dynamic Arterial Elastance in Predicting Vasopressor Requirement After Anesthesia Induction in Patients Undergoing Elective On-Pump Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT07871201
- Acronym / sponsor ID
- 2026/317
- Conditions
- Coronary Artery Disease
- Keywords
- Dynamic Arterial Elastance, EaDyn, Vasopressor Requirement, Coronary Artery Bypass Greft, CABG, Anesthesia Induction, Pulse Pressure Variation, Stroke Volume Variation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Elzem SENUniversity, hospital or other
- Study start
- 1 Oct 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 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 determine whether dynamic arterial elastance (EaDyn), measured after anesthesia induction, can predict the need for vasopressor treatment in patients undergoing elective on-pump coronary artery bypass graft surgery. EaDyn will be calculated from pulse pressure variation and stroke volume variation. Hemodynamic measurements will be recorded before anesthesia induction and at 1, 3, and 5 minutes after induction. The study is prospective and observational, and no additional intervention will be performed as part of the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Elective On-Pump CABG Cohort | – | Other: No interventionAdults aged 18-80 years undergoing elective on-pump coronary artery bypass graft surgery who meet the study eligibility criteria. Hemodynamic parameters will be recorded before and after anesthesia induction, and vasopressor use will be documented. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18-80 years undergoing elective on-pump coronary artery bypass graft surgery at Gaziantep University Hospital who meet the predefined inclusion and exclusion criteria. Patients will undergo routine anesthesia and surgical management. Hemodynamic parameters will be recorded before anesthesia induction and at 1, 3, and 5 minutes after induction, and vasopressor use will be documented.
Key inclusion criteria (4 listed)
- Age ≥18 years.
- Patients undergoing elective cardiac surgery with cardiopulmonary bypass (on-pump).
- Patients with arterial catheter monitoring.
- Patients receiving mechanical ventilation.
Key exclusion criteria (6 listed)
- Arrhythmia (e.g., atrial fibrillation).
- Severe aortic regurgitation.
- Spontaneous breathing.
- Low tidal volume.
- Emergency surgery.
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 interventionThis is an observational study. No study-specific intervention is assigned to participants. Anesthesia and surgical management will be performed according to routine clinical practice. | Other | Elective On-Pump CABG Cohort |
Primary outcome
Vasopressor Requirement Within 5 Minutes After Anesthesia Induction
Time frame: From anesthesia induction to 5 minutes after induction
Requirement for administration of any vasopressor after anesthesia induction, recorded as a binary outcome (yes/no). Vasopressor use will be assessed during the post-induction hemodynamic assessment period.
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 34017263Bar S, Nguyen M, Abou-Arab O, Dupont H, Bouhemad B, Guinot PG. Dynamic Arterial Elastance Is Associated With the Vascular Waterfall in Patients Treated With Norepinephrine: An Observational Study. Front Physiol. 2021 May 4;12:583370. doi: 10.3389/fphys.2021.583370. eCollection 2021.
- 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 25407570Garcia MI, Romero MG, Cano AG, Aya HD, Rhodes A, Grounds RM, Cecconi M. Dynamic arterial elastance as a predictor of arterial pressure response to fluid administration: a validation study. Crit Care. 2014 Nov 19;18(6):626. doi: 10.1186/s13054-014-0626-6.
- Background: PubMed 21226909Monge Garcia MI, Gil Cano A, Gracia Romero M. Dynamic arterial elastance to predict arterial pressure response to volume loading in preload-dependent patients. Crit Care. 2011;15(1):R15. doi: 10.1186/cc9420. Epub 2011 Jan 12.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. No plan has been established for sharing individual-level participant data beyond the research team. Study results will be reported in aggregate form.
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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.
ELZEM ŞEN, MD study chair
University of Gaziantep
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 4 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?
Vasopressor Requirement Within 5 Minutes After Anesthesia Induction (time frame: From anesthesia induction to 5 minutes after induction). 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 NCT07871201, which also lists 4 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.