Hypotension on InductionNCT07541222
The Impact of Multiple Antihypertensive Therapy on Post-Induction Hypotension Burden in Cardiac Surgery Patients
An observational study of Hypotension on Induction and Cardiac Surgery, run by Konya City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This study aims to investigate the impact of multiple preoperative antihyperstensive drug use on the burden of post-induction hypotension (PIH) in patients undergoing elective cardiac surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hypotension on Induction, Cardiac Surgery, Antihypertensive Agents
- What is being tested?
- Chronic Antihypertensive Medication Use
- Type of treatment
- Injection or infusion
- How many people
- 103 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2026to 28 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (40 years and older) who are scheduled for elective cardiac surgery under general anesthesia at a single tertiary center and have been on a stable regimen of one or more antihypertensive medications for at least one month preoperatively.
Who may be able to join
- Adult patients aged 40 years and older
- Undergoing elective cardiac surgery (e.g., isolated CABG, isolated valve surgery, or combined CABG+valve surgery via sternotomy)
- Regular use of at least one antihypertensive medication for at least 4 weeks prior to the operation date
- Voluntary participation and signed informed consent
Who cannot join
- Emergency surgery
- Preoperative shock or requirement for high-dose inotropic/vasopressor therapy
- End-stage liver or kidney failure
- Uncontrolled hypertension
- Difficult intubation or prolonged induction process
- Ejection fraction less than 35%
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Konya City Hospital
Konya, 42080
About this study
Official title: The Impact of Multiple Antihypertensive Therapy on Post-Induction Hypotension Burden in Cardiac Surgery Patients: A Prospective Observational Cohort Study
This study aims to investigate the impact of multiple preoperative antihyperstensive drug use on the burden of post-induction hypotension (PIH) in patients undergoing elective cardiac surgery. The researchers will observe whether the combination of different antihypertensive classes (such as ACE inhibitors, ARBs, beta-blockers, and calcium channel blockers) leads to a higher incidence and severity of blood pressure drops and increased need for vasoactive support during the period between anesthesia induction and surgical incision.
Read the detailed description
Post-induction hypotension (PIH) is a critical period in cardiac anesthesia that can lead to organ hypoperfusion. This prospective observational study will include patients aged 18-85 with ASA III-IV physical status scheduled for elective cardiac surgery.
Preoperatively, patients' chronic antihypertensive medications will be recorded and categorized. Following standard anesthesia induction, hemodynamic parameters will be monitored using invasive arterial blood pressure measurement. PIH burden will be defined as the area under the curve (AUC) for a mean arterial pressure (MAP) lower than 65 mmHg. Additionally, the study will record the total dose of ephedrine or other vasoactive agents required to maintain hemodynamic stability. The primary goal is to determine if multiple antihypertensive therapy is an independent risk factor for increased PIH burden and to compare the effects of different drug combinations on early intraoperative hemodynamics.
- Conditions
- Hypotension on Induction, Cardiac Surgery, Antihypertensive Agents, Anesthesia, Intravenous, Hemodynamics
- Being tested
- Chronic Antihypertensive Medication Use
- Keywords
- Post-induction hypotension, Cardiac surgery, Antihypertensive drugs, Hypotension burden, Mean arterial pressure, Anesthesia induction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chronic Antihypertensive Medication UseOther
Also called Multiple Antihypertensive Therapy
Patients' chronic antihypertensive drug use (number of drugs and pharmacological classes) will be recorded. This is an observational study where existing medication regimens (ACE inhibitors, ARBs, Beta-blockers, Calcium Channel Blockers, Diuretics) are documented to analyze their impact on the post-induction hypotension burden (MAP < 55 mmHg).
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | Adult patients aged 18 to 85 years with ASA physical status III-IV, who are scheduled to undergo elective cardiac surgery under general anesthesia. Receives: Other: Chronic Antihypertensive Medication Use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-induction Hypotension (PIH) Burden
The hypotension burden is defined as the area under the threshold (AUT) for a mean arterial pressure (MAP) <55 mmHg. It is calculated using the formula: AUT<55 = ∫(55 - MAP(t))dt for all values where MAP is below 55 mmHg. This measure integrates both the severity and duration of hypotension.
Measured: From the start of anesthesia induction until 15 minutes post-induction or until central venous catheter placement, whichever occurs first.
Secondary outcomes (2)
Total Vasopressor Dose
The total amount of vasopressors (e.g., ephedrine, norepinephrine) administered to treat post-induction hypotension.
Measured: From the start of anesthesia induction until 15 minutes post-induction.
Incidence of Post-induction Hypotension
Percentage of patients experiencing at least one episode of MAP <55 mmHg.
Measured: From the start of anesthesia induction until 15 minutes post-induction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 May 2026
- Primary completion28 Oct 2026
- Study completion28 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hypotension on InductionStudies 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
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Aydemir, Konya City Hospital
- Investigators
- Mustafa Aydemir, MD, Principal investigator, Konya City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07541222
- Sponsor's protocol ID
- 2026/026
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data underlying the results reported in this article will be available after publication to researchers who provide a methodologically sound proposal.
Publications
Chen B, Pang QY, An R, Liu HL. A systematic review of risk factors for postinduction hypotension in surgical patients undergoing general anesthesia. Eur Rev Med Pharmacol Sci. 2021 Nov;25(22):7044-7050. doi: 10.26355/eurrev_202111_27255.
PubMed 34859868Hojo T, Kimura Y, Shibuya M, Fujisawa T. Predictors of hypotension during anesthesia induction in patients with hypertension on medication: a retrospective observational study. BMC Anesthesiol. 2022 Nov 11;22(1):343. doi: 10.1186/s12871-022-01899-9.
PubMed 36368916Writing Committee Members*; Jones DW, Ferdinand KC, Taler SJ, Johnson HM, Shimbo D, Abdalla M, Altieri MM, Bansal N, Bello NA, Bress AP, Carter J, Cohen JB, Collins KJ, Commodore-Mensah Y, Davis LL, Egan B, Khan SS, Lloyd-Jones DM, Melnyk BM, Mistry EA, Ogunniyi MO, Schott SL, Smith SC Jr, Talbot AW, Vongpatanasin W, Watson KE, Whelton PK, Williamson JD. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Sep 16;152(11):e114-e218. doi: 10.1161/CIR.0000000000001356. Epub 2025 Aug 14.
PubMed 40811497Praz F, Lanz J, Adamo M, Borger M. Reply to Garcia-Villarreal et al. concerning the 2025 ESC/EACTS Guidelines for the Management of Valvular Heart Disease. Eur J Cardiothorac Surg. 2025 Nov 2;67(11):ezaf393. doi: 10.1093/ejcts/ezaf393. No abstract available.
PubMed 41217787Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
PubMed 34453165Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 May 15;71(19):e127-e248. doi: 10.1016/j.jacc.2017.11.006. Epub 2017 Nov 13. No abstract available.
PubMed 29146535
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Multiple Antihypertensive Therapy on Post-Induction Hypotension Burden in Cardiac Surgery Patients: A Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07541222
- Acronym / sponsor ID
- 2026/026
- Conditions
- Hypotension on Induction, Cardiac Surgery, Antihypertensive Agents, Anesthesia, Intravenous, Hemodynamics
- Keywords
- Post-induction hypotension, Cardiac surgery, Antihypertensive drugs, Hypotension burden, Mean arterial pressure, Anesthesia induction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Konya City HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 28 Oct 2026 (actual)
- Study completion
- 28 Oct 2026 (actual)
- First posted
- 21 Apr 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 investigate the impact of multiple preoperative antihyperstensive drug use on the burden of post-induction hypotension (PIH) in patients undergoing elective cardiac surgery. The researchers will observe whether the combination of different antihypertensive classes (such as ACE inhibitors, ARBs, beta-blockers, and calcium channel blockers) leads to a higher incidence and severity of blood pressure drops and increased need for vasoactive support during the period between anesthesia induction and surgical incision.
Detailed description
Post-induction hypotension (PIH) is a critical period in cardiac anesthesia that can lead to organ hypoperfusion. This prospective observational study will include patients aged 18-85 with ASA III-IV physical status scheduled for elective cardiac surgery.
Preoperatively, patients' chronic antihypertensive medications will be recorded and categorized. Following standard anesthesia induction, hemodynamic parameters will be monitored using invasive arterial blood pressure measurement. PIH burden will be defined as the area under the curve (AUC) for a mean arterial pressure (MAP) lower than 65 mmHg. Additionally, the study will record the total dose of ephedrine or other vasoactive agents required to maintain hemodynamic stability. The primary goal is to determine if multiple antihypertensive therapy is an independent risk factor for increased PIH burden and to compare the effects of different drug combinations on early intraoperative hemodynamics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Other: Chronic Antihypertensive Medication UseAdult patients aged 18 to 85 years with ASA physical status III-IV, who are scheduled to undergo elective cardiac surgery under general anesthesia. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (40 years and older) who are scheduled for elective cardiac surgery under general anesthesia at a single tertiary center and have been on a stable regimen of one or more antihypertensive medications for at least one month preoperatively.
Key inclusion criteria (4 listed)
- Adult patients aged 40 years and older
- Undergoing elective cardiac surgery (e.g., isolated CABG, isolated valve surgery, or combined CABG+valve surgery via sternotomy)
- Regular use of at least one antihypertensive medication for at least 4 weeks prior to the operation date
- Voluntary participation and signed informed consent
Key exclusion criteria (6 listed)
- Emergency surgery
- Preoperative shock or requirement for high-dose inotropic/vasopressor therapy
- End-stage liver or kidney failure
- Uncontrolled hypertension
- Difficult intubation or prolonged induction process
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 |
|---|---|---|
| Chronic Antihypertensive Medication UseAlso: Multiple Antihypertensive TherapyPatients' chronic antihypertensive drug use (number of drugs and pharmacological classes) will be recorded. This is an observational study where existing medication regimens (ACE inhibitors, ARBs, Beta-blockers, Calcium Channel Blockers, Diuretics) are documented to analyze their impact on the post-induction hypotension burden (MAP < 55 mmHg). | Other | Study Cohort |
Primary outcome
Post-induction Hypotension (PIH) Burden
Time frame: From the start of anesthesia induction until 15 minutes post-induction or until central venous catheter placement, whichever occurs first.
The hypotension burden is defined as the area under the threshold (AUT) for a mean arterial pressure (MAP) <55 mmHg. It is calculated using the formula: AUT<55 = ∫(55 - MAP(t))dt for all values where MAP is below 55 mmHg. This measure integrates both the severity and duration of hypotension.
2 secondary outcomes
Total Vasopressor Dose
Time frame: From the start of anesthesia induction until 15 minutes post-induction.
Incidence of Post-induction Hypotension
Time frame: From the start of anesthesia induction until 15 minutes post-induction.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Background: PubMed 34859868Chen B, Pang QY, An R, Liu HL. A systematic review of risk factors for postinduction hypotension in surgical patients undergoing general anesthesia. Eur Rev Med Pharmacol Sci. 2021 Nov;25(22):7044-7050. doi: 10.26355/eurrev_202111_27255.
- Background: PubMed 36368916Hojo T, Kimura Y, Shibuya M, Fujisawa T. Predictors of hypotension during anesthesia induction in patients with hypertension on medication: a retrospective observational study. BMC Anesthesiol. 2022 Nov 11;22(1):343. doi: 10.1186/s12871-022-01899-9.
- Background: PubMed 40811497Writing Committee Members*; Jones DW, Ferdinand KC, Taler SJ, Johnson HM, Shimbo D, Abdalla M, Altieri MM, Bansal N, Bello NA, Bress AP, Carter J, Cohen JB, Collins KJ, Commodore-Mensah Y, Davis LL, Egan B, Khan SS, Lloyd-Jones DM, Melnyk BM, Mistry EA, Ogunniyi MO, Schott SL, Smith SC Jr, Talbot AW, Vongpatanasin W, Watson KE, Whelton PK, Williamson JD. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Sep 16;152(11):e114-e218. doi: 10.1161/CIR.0000000000001356. Epub 2025 Aug 14.
- Background: PubMed 41217787Praz F, Lanz J, Adamo M, Borger M. Reply to Garcia-Villarreal et al. concerning the 2025 ESC/EACTS Guidelines for the Management of Valvular Heart Disease. Eur J Cardiothorac Surg. 2025 Nov 2;67(11):ezaf393. doi: 10.1093/ejcts/ezaf393. No abstract available.
- Background: PubMed 34453165Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available.
- Background: PubMed 29146535Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 May 15;71(19):e127-e248. doi: 10.1016/j.jacc.2017.11.006. Epub 2017 Nov 13. No abstract available.
- Individual participant dataSharing planned: No. De-identified individual participant data underlying the results reported in this article will be available after publication to researchers who provide a methodologically sound proposal.
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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. This study is not recruiting at the moment.
Mustafa Aydemir, MD principal investigator
Konya City Hospital
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 Hypotension on Induction and Cardiac Surgery, run by Konya City Hospital 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: finished, as of the sponsor's last update on 29 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-induction Hypotension (PIH) Burden (time frame: From the start of anesthesia induction until 15 minutes post-induction or until central venous catheter placement, whichever occurs first.). 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 NCT07541222, which also lists 6 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 29 Oct 2026.