HypotensionBBBNCT02533128
Biomarkers, Blood Pressure, BIS: Risk Stratification/Management of Patients at Cardiac Risk in Major Noncardiac Surgery
A study testing Liberal blood pressure management and Tight blood pressure management in people with Hypotension and Postoperative Complications, run by Miodrag Filipovic, Prof. Dr. med. at 1 site in Switzerland.
Trial summary
Major adverse cardiovascular events (MACE) are a leading cause of serious complications and death following major noncardiac surgery. The heart biomarkers brain-type natriuretic peptide (BNP) and high-sensitivity troponin I/T (hs-TnI/T), may aid in estimating the risk of surgery - low values may permit identifying… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Hypotension, Postoperative Complications, Acute Coronary Syndrome
- What is being tested?
- Liberal blood pressure management and Tight blood pressure management
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 458 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Oct 2015to 17 Apr 2020
- Phase
- Interventional
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A) undergoing major noncardiac surgery, defined as:
- vascular surgery (with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies)
- intraperitoneal surgery
- intrathoracic surgery
- major orthopedic surgery
- B) at cardiovascular risk, defined as meeting at least 1 of the following 6 criteria:
Show all 19Show fewer
- history of coronary artery disease
- history of peripheral vascular disease
- history of stroke
- hospitalization for congestive heart failure
- undergoing major vascular surgery, with the exception of arteriovenous shunt, vein stripping procedures and carotid endarterectomies
- fulfillment of any 3 of the 7 Lee criteria, defined as:
- undergoing intrathoracic or intraperitoneal surgery
- anamnestic transient ischemic attack (TIA)
- any history of CHF or history of pulmonary edema
- diabetes
- serum creatinine > 175 mcmol/l
- age > 70 years
- undergoing emergent or urgent surgery
Who cannot join
- General
- pregnancy
- inclusion in another clinical trial with any endpoints in common with the BBB Study: hs-cTnI, components of MACE (acute coronary syndrome [ACS], congestive heart failure [CHF], coronary revascularization, stroke, acute kidney injury [AKI], new chronic kidney disease [CKD] or progression of CKD, mortality)
- previously enrolled in BBB Study
- RCT
- emergent surgery
Show all 12Show fewer
- presence of any active cardiac conditions:
- unstable coronary syndromes: unstable or severe (CCS III or IV) angina
- decompensated heart failure: NYHA IV, worsening or new-onset
- significant arrhythmias: high-grade AV-block (Mobitz II and third-degree), symptomatic bradycardia, symptomatic ventricular arrhythmias, supraventricular arrhythmias with uncontrolled ventricular rate (>100bpm at rest), newly recognized ventricular tachycardia
- severe valvular disease: severe aortic stenosis (mean pressure gradient > 40 mmHg, aortic valve area < 1.0 cm2, symptomatic), symptomatic mitral stenosis (progressive dyspnea on exertion, externional presyncope, heart failure)
- any transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Biomarkers, Blood Pressure and BIS: Perioperative Risk Stratification and Management Optimization of Patients at Cardiac Risk Undergoing Major Noncardiac Surgery (The BBB Study)
Major adverse cardiovascular events (MACE) are a leading cause of serious complications and death following major noncardiac surgery. The heart biomarkers brain-type natriuretic peptide (BNP) and high-sensitivity troponin I/T (hs-TnI/T), may aid in estimating the risk of surgery - low values may permit identifying patients at a very low risk of postoperative complications, potentially helping to avoid unnecessary tests and delays prior to surgery.
Recent studies suggest that the manner in which an anesthetic is conducted may have an important impact on postoperative outcomes. The combination of low blood pressure (BP) and a deep level of anesthesia despite a low dose of anesthetic - also known as a "triple low" - has been linked to increased complications and death following surgery. However, it is unclear whether triple lows actually cause postoperative complications or whether they are merely an indicator of a sick patient, who is in general more likely to suffer from cardiovascular events in the near future. To answer this question, in this study patients will be randomly assigned to groups with lower and higher blood pressures, and the postoperative rates of major adverse cardiovascular events and of relevant increases in hs-TnI (a marker of cardiac injury) compared.
Another important question is that of the optimal blood pressure target during surgery. Currently there are no established methods of tailoring blood pressure management to the individual patient. In the study the investigators will perform ambulatory 24h BP measurements prior to surgery to measure the patients' average BP during sleep. In the analysis of the study data, the investigators will try to determine the relationship of preoperative biomarker levels, intraoperative BP (both in relation to fixed targets and to the patient's own night-time BP) and of anesthetic depth with the occurrence of major adverse cardiovascular events after surgery.
Read the detailed description
- Hypothesis and purpose This study is based on the hypothesis that normal preoperative cardiac biomarkers, lack of intraoperative hypotension and BIS values between 45-60 are associated with better outcomes compared with elevated biomarkers, intraoperative hypotension and/or BIS values below 45. Additionally, the investigators hypothesize that tight blood pressure management reduces the incidence of adverse outcomes compared to liberal blood pressure management (see below for definitions). Lastly, the investigators will test the hypothesis that individualized, relative lower limits of blood pressure are a better predictor of adverse outcomes than absolute, non-individualized limits.
- Study design The study will be comprised of a cohort study (RISK) and a nested randomized controlled trial (RCT) [HEMODYNAMICS]. In the period between September 2015 and August 2018 all patients meeting the inclusion criteria will be included in the cohort study to assess the association of perioperative biomarkers, intraoperative blood pressure and BIS values with the occurrence of MACE. A smaller subset of patients will additionally be included in the RCT to assess the effect of tight versus liberal blood pressure management on MACE. Cardiac risk assessment and optimization will be performed according to clinical practice in the investigators' institution, following internal guidelines (based on the 2007 ACC/AHA guidelines. In addition, preoperative cardiac biomarkers (BNP and hsTnI) will be measured. Intraoperative blood pressure management will be based on an internal hemodynamic management algorithm, however in the cohort study the intervention threshold will be left at the discretion of the anesthesiologist. The occurrence of MACE will be assessed 30 days and one year after surgery. The association of preoperative biomarker levels and the occurrence of intraoperative hypotension will be investigated. In the RCT, patients will be assessed similarly to the protocol of the cohort study, however these patients will be randomly assigned to either tight (mean arterial pressure [MAP] > 75 mmHg) or liberal (MAP at the discretion of the anesthesiologist, but not < 60mmHg) blood pressure management using the same hemodynamic management algorithm as in the whole cohort. In a subset of the RCT patients, a nighttime blood pressure profile will be obtained additionally to define a presumed individual lower blood pressure limit (i.e. the mean MAP during natural sleep). The association of intraoperative time spent below the individual lower blood pressure limit with the occurrence of adverse outcomes will be assessed. Additionally, the association of postoperative parameters (e.g. the time spent below a given blood pressure threshold) with the occurrence of MACE will be investigated. Further, the association of perioperative levels of the biomarkers midregional proadrenomedullin (MR-proADM) and high-sensitivity cardiac troponin T (hs-TnT) with the occurrence of MACE will be investigated. Lastly, fully anonymised patient data from the BBB-Study may be included in multicenter cohort studies investigating perioperative myocardial ischemia and hemodynamic stability.
- Sample Size The sample size calculation of the Clinical Trials Unit St. Gallen indicates that in the RCT, assuming a 10% drop-out rate, 458 patients will be necessary to detect an a difference of 33% between the liberal and tight BP groups in our primary composite endpoint of MACE (α=0.05, β=0.2).
- Statistical Analysis
In the RCT, potential differences between the incidence of the primary endpoint in the tight and liberal BP groups will be assessed using χ2 statistics. In the cohort study, the investigators will generate logistic regression models using the primary (or secondary) outcome as a dependent variable. The investigators will model the preoperative level of cardiac biomarkers (in quartiles and dichotomized), time spent below a prespecified mean arterial pressure (< 75 mmHg, < 60 and below the individual average mean arterial pressure during natural sleep) and time spent below a BIS < 45. The model will be adjusted for the following prespecified independent variables: Charlson Comorbidity Index, Lee Revised Cardiac Risk Index, age and sex. The number of independent variables will be limited to avoid overfitting of the model. For dichotomization of BNP, the investigators will define the optimal cut-off value using receiver operating characteristics curves for the primary outcome under assumption of equal weight sensitivity and specificity. The null hypothesis will be considered refuted if the 2-sided p-value is < 0.05.
Based on previous experience in similar studies, the investigators expect a very small number of loss of follow up (< 2%). If the number exceeds 5% a Cox regression model using time to the composite endpoint (or time to last contact, if loss of follow up has occurred) as a dependent variable will be calculated. Missing perioperative BNP values will be handled as normal (< 50 pg/ml). Any other missing perioperative laboratory values shall also be assumed to be normal.
- Conditions
- Hypotension, Postoperative Complications, Acute Coronary Syndrome, Heart Failure, Coronary Occlusion, Stroke
- Being tested
- Liberal blood pressure management, Tight blood pressure management
- Keywords
- Intraoperative blood pressure, Triple low, Anesthetic overdose, Major adverse cardiac events (MACE), Myocardial injury after noncardiac surgery (MINS), Perioperative risk stratification, Brain-type natriuretic peptide (BNP), High-sensitivity cardiac Troponin I (hs-cTnI)
- Medical subject headings
- Hypotension, Postoperative Complications, Acute Coronary Syndrome, Heart Failure, Coronary Occlusion, Stroke, Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liberal blood pressure managementDrug
Protocolized hemodynamic management to maintain mean arterial pressure (MAP) > 60 mmHg
Tight blood pressure managementDrug
Protocolized hemodynamic management to maintain mean arterial pressure (MAP) > 75 mmHg
| Study group | Role | What they receive |
|---|---|---|
| Liberal blood pressure management | Placebo comparator | Not described Receives: Drug: Liberal blood pressure management |
| Tight blood pressure management | Active comparator | Not described Receives: Drug: Tight blood pressure management |
What is being measured
The primary outcome is the main question the study is designed to answer.
High-sensitivity cardiac Troponin I (hs-cTnI) > 0.04ng/ml and >= 35% relative increase compared to preoperative value
Measured: Postoperative days 0-3
Major adverse cardiovascular events
Acute coronary syndrome, new or worsening congestive heart failure, coronary revascularization, stroke, acute kidney injury, all-cause mortality
Measured: 30 days postoperatively
Secondary outcomes (1)
Major adverse cardiovascular events
Acute coronary syndrome, new or worsening congestive heart failure, coronary revascularization, stroke, new diagnosis of chronic kidney disease (CKD) or progression of pre-existing CKD, all-cause mortality
Measured: 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study start14 Oct 2015
- Primary completion17 May 2019
- Study completion17 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypotensionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miodrag Filipovic, Prof. Dr. med.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Miodrag Filipovic, Prof. Dr. med., Cantonal Hospital of St. Gallen
- Investigators
- Miodrag Filipovic, Prof. Dr., Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533128
- Sponsor's protocol ID
- EKSG 15/003
- Acronym
- BBB
- Status last verified
- Jul 2020
- First submitted
- 24 Aug 2015
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sessler DI, Sigl JC, Kelley SD, Chamoun NG, Manberg PJ, Saager L, Kurz A, Greenwald S. Hospital stay and mortality are increased in patients having a "triple low" of low blood pressure, low bispectral index, and low minimum alveolar concentration of volatile anesthesia. Anesthesiology. 2012 Jun;116(6):1195-203. doi: 10.1097/ALN.0b013e31825683dc.
PubMed 22546967Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof E, Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten JR, Riegel B, Robb JF, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Buller CE, Creager MA, Ettinger SM, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Ornato JP, Page RL, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery); American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Rhythm Society; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society for Vascular Surgery. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery): developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. Circulation. 2007 Oct 23;116(17):e418-99. doi: 10.1161/CIRCULATIONAHA.107.185699. Epub 2007 Sep 27. No abstract available.
PubMed 17901357Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 9;130(24):e278-333. doi: 10.1161/CIR.0000000000000106. Epub 2014 Aug 1. No abstract available.
PubMed 25085961Kristensen SD, Knuuti J, Saraste A, Anker S, Botker HE, Hert SD, Ford I, Gonzalez-Juanatey JR, Gorenek B, Heyndrickx GR, Hoeft A, Huber K, Iung B, Kjeldsen KP, Longrois D, Luscher TF, Pierard L, Pocock S, Price S, Roffi M, Sirnes PA, Sousa-Uva M, Voudris V, Funck-Brentano C; Authors/Task Force Members. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur Heart J. 2014 Sep 14;35(35):2383-431. doi: 10.1093/eurheartj/ehu282. Epub 2014 Aug 1. No abstract available.
PubMed 25086026Wanner PM, Wulff DU, Djurdjevic M, Korte W, Schnider TW, Filipovic M. Targeting Higher Intraoperative Blood Pressures Does Not Reduce Adverse Cardiovascular Events Following Noncardiac Surgery. J Am Coll Cardiol. 2021 Nov 2;78(18):1753-1764. doi: 10.1016/j.jacc.2021.08.048.
PubMed 34711333
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers, Blood Pressure and BIS: Perioperative Risk Stratification and Management Optimization of Patients at Cardiac Risk Undergoing Major Noncardiac Surgery (The BBB Study)
- ClinicalTrials.gov ID
- NCT02533128
- Acronym / sponsor ID
- BBB / EKSG 15/003
- Conditions
- Hypotension, Postoperative Complications, Acute Coronary Syndrome, Heart Failure, Coronary Occlusion, Stroke
- Keywords
- Intraoperative blood pressure, Triple low, Anesthetic overdose, Major adverse cardiac events (MACE), Myocardial injury after noncardiac surgery (MINS), Perioperative risk stratification, Brain-type natriuretic peptide (BNP), High-sensitivity cardiac Troponin I (hs-cTnI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Miodrag Filipovic, Prof. Dr. med.University, hospital or other
- Study start
- 14 Oct 2015
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 26 Aug 2015 (estimated)
- 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.
Major adverse cardiovascular events (MACE) are a leading cause of serious complications and death following major noncardiac surgery. The heart biomarkers brain-type natriuretic peptide (BNP) and high-sensitivity troponin I/T (hs-TnI/T), may aid in estimating the risk of surgery - low values may permit identifying patients at a very low risk of postoperative complications, potentially helping to avoid unnecessary tests and delays prior to surgery.
Recent studies suggest that the manner in which an anesthetic is conducted may have an important impact on postoperative outcomes. The combination of low blood pressure (BP) and a deep level of anesthesia despite a low dose of anesthetic - also known as a "triple low" - has been linked to increased complications and death following surgery. However, it is unclear whether triple lows actually cause postoperative complications or whether they are merely an indicator of a sick patient, who is in general more likely to suffer from cardiovascular events in the near future. To answer this question, in this study patients will be randomly assigned to groups with lower and higher blood pressures, and the postoperative rates of major adverse cardiovascular events and of relevant increases in hs-TnI (a marker of cardiac injury) compared.
Another important question is that of the optimal blood pressure target during surgery. Currently there are no established methods of tailoring blood pressure management to the individual patient. In the study the investigators will perform ambulatory 24h BP measurements prior to surgery to measure the patients' average BP during sleep. In the analysis of the study data, the investigators will try to determine the relationship of preoperative biomarker levels, intraoperative BP (both in relation to fixed targets and to the patient's own night-time BP) and of anesthetic depth with the occurrence of major adverse cardiovascular events after surgery.
Detailed description
- Hypothesis and purpose This study is based on the hypothesis that normal preoperative cardiac biomarkers, lack of intraoperative hypotension and BIS values between 45-60 are associated with better outcomes compared with elevated biomarkers, intraoperative hypotension and/or BIS values below 45. Additionally, the investigators hypothesize that tight blood pressure management reduces the incidence of adverse outcomes compared to liberal blood pressure management (see below for definitions). Lastly, the investigators will test the hypothesis that individualized, relative lower limits of blood pressure are a better predictor of adverse outcomes than absolute, non-individualized limits.
- Study design The study will be comprised of a cohort study (RISK) and a nested randomized controlled trial (RCT) [HEMODYNAMICS]. In the period between September 2015 and August 2018 all patients meeting the inclusion criteria will be included in the cohort study to assess the association of perioperative biomarkers, intraoperative blood pressure and BIS values with the occurrence of MACE. A smaller subset of patients will additionally be included in the RCT to assess the effect of tight versus liberal blood pressure management on MACE. Cardiac risk assessment and optimization will be performed according to clinical practice in the investigators' institution, following internal guidelines (based on the 2007 ACC/AHA guidelines. In addition, preoperative cardiac biomarkers (BNP and hsTnI) will be measured. Intraoperative blood pressure management will be based on an internal hemodynamic management algorithm, however in the cohort study the intervention threshold will be left at the discretion of the anesthesiologist. The occurrence of MACE will be assessed 30 days and one year after surgery. The association of preoperative biomarker levels and the occurrence of intraoperative hypotension will be investigated. In the RCT, patients will be assessed similarly to the protocol of the cohort study, however these patients will be randomly assigned to either tight (mean arterial pressure [MAP] > 75 mmHg) or liberal (MAP at the discretion of the anesthesiologist, but not < 60mmHg) blood pressure management using the same hemodynamic management algorithm as in the whole cohort. In a subset of the RCT patients, a nighttime blood pressure profile will be obtained additionally to define a presumed individual lower blood pressure limit (i.e. the mean MAP during natural sleep). The association of intraoperative time spent below the individual lower blood pressure limit with the occurrence of adverse outcomes will be assessed. Additionally, the association of postoperative parameters (e.g. the time spent below a given blood pressure threshold) with the occurrence of MACE will be investigated. Further, the association of perioperative levels of the biomarkers midregional proadrenomedullin (MR-proADM) and high-sensitivity cardiac troponin T (hs-TnT) with the occurrence of MACE will be investigated. Lastly, fully anonymised patient data from the BBB-Study may be included in multicenter cohort studies investigating perioperative myocardial ischemia and hemodynamic stability.
- Sample Size The sample size calculation of the Clinical Trials Unit St. Gallen indicates that in the RCT, assuming a 10% drop-out rate, 458 patients will be necessary to detect an a difference of 33% between the liberal and tight BP groups in our primary composite endpoint of MACE (α=0.05, β=0.2).
- Statistical Analysis
In the RCT, potential differences between the incidence of the primary endpoint in the tight and liberal BP groups will be assessed using χ2 statistics. In the cohort study, the investigators will generate logistic regression models using the primary (or secondary) outcome as a dependent variable. The investigators will model the preoperative level of cardiac biomarkers (in quartiles and dichotomized), time spent below a prespecified mean arterial pressure (< 75 mmHg, < 60 and below the individual average mean arterial pressure during natural sleep) and time spent below a BIS < 45. The model will be adjusted for the following prespecified independent variables: Charlson Comorbidity Index, Lee Revised Cardiac Risk Index, age and sex. The number of independent variables will be limited to avoid overfitting of the model. For dichotomization of BNP, the investigators will define the optimal cut-off value using receiver operating characteristics curves for the primary outcome under assumption of equal weight sensitivity and specificity. The null hypothesis will be considered refuted if the 2-sided p-value is < 0.05.
Based on previous experience in similar studies, the investigators expect a very small number of loss of follow up (< 2%). If the number exceeds 5% a Cox regression model using time to the composite endpoint (or time to last contact, if loss of follow up has occurred) as a dependent variable will be calculated. Missing perioperative BNP values will be handled as normal (< 50 pg/ml). Any other missing perioperative laboratory values shall also be assumed to be normal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liberal blood pressure management | Placebo comparator | Drug: Liberal blood pressure management |
| Tight blood pressure management | Active comparator | Drug: Tight blood pressure management |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- A) undergoing major noncardiac surgery, defined as:
- B) at cardiovascular risk, defined as meeting at least 1 of the following 6 criteria:
Key exclusion criteria (12 listed)
- General
- RCT
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 |
|---|---|---|
| Liberal blood pressure managementProtocolized hemodynamic management to maintain mean arterial pressure (MAP) > 60 mmHg | Drug | Liberal blood pressure management |
| Tight blood pressure managementProtocolized hemodynamic management to maintain mean arterial pressure (MAP) > 75 mmHg | Drug | Tight blood pressure management |
Primary outcome
High-sensitivity cardiac Troponin I (hs-cTnI) > 0.04ng/ml and >= 35% relative increase compared to preoperative value
Time frame: Postoperative days 0-3
Major adverse cardiovascular events
Time frame: 30 days postoperatively
Acute coronary syndrome, new or worsening congestive heart failure, coronary revascularization, stroke, acute kidney injury, all-cause mortality
1 secondary outcome
Major adverse cardiovascular events
Time frame: 1 year postoperatively
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 15 Jul 2020.
- Background: PubMed 22546967Sessler DI, Sigl JC, Kelley SD, Chamoun NG, Manberg PJ, Saager L, Kurz A, Greenwald S. Hospital stay and mortality are increased in patients having a "triple low" of low blood pressure, low bispectral index, and low minimum alveolar concentration of volatile anesthesia. Anesthesiology. 2012 Jun;116(6):1195-203. doi: 10.1097/ALN.0b013e31825683dc.
- Background: PubMed 17901357Fleisher LA, Beckman JA, Brown KA, Calkins H, Chaikof E, Fleischmann KE, Freeman WK, Froehlich JB, Kasper EK, Kersten JR, Riegel B, Robb JF, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Buller CE, Creager MA, Ettinger SM, Faxon DP, Fuster V, Halperin JL, Hiratzka LF, Hunt SA, Lytle BW, Nishimura R, Ornato JP, Page RL, Tarkington LG, Yancy CW; American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery); American Society of Echocardiography; American Society of Nuclear Cardiology; Heart Rhythm Society; Society of Cardiovascular Anesthesiologists; Society for Cardiovascular Angiography and Interventions; Society for Vascular Medicine and Biology; Society for Vascular Surgery. ACC/AHA 2007 guidelines on perioperative cardiovascular evaluation and care for noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines on Perioperative Cardiovascular Evaluation for Noncardiac Surgery): developed in collaboration with the American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society of Cardiovascular Anesthesiologists, Society for Cardiovascular Angiography and Interventions, Society for Vascular Medicine and Biology, and Society for Vascular Surgery. Circulation. 2007 Oct 23;116(17):e418-99. doi: 10.1161/CIRCULATIONAHA.107.185699. Epub 2007 Sep 27. No abstract available.
- Background: PubMed 25085961Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation. 2014 Dec 9;130(24):e278-333. doi: 10.1161/CIR.0000000000000106. Epub 2014 Aug 1. No abstract available.
- Background: PubMed 25086026Kristensen SD, Knuuti J, Saraste A, Anker S, Botker HE, Hert SD, Ford I, Gonzalez-Juanatey JR, Gorenek B, Heyndrickx GR, Hoeft A, Huber K, Iung B, Kjeldsen KP, Longrois D, Luscher TF, Pierard L, Pocock S, Price S, Roffi M, Sirnes PA, Sousa-Uva M, Voudris V, Funck-Brentano C; Authors/Task Force Members. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur Heart J. 2014 Sep 14;35(35):2383-431. doi: 10.1093/eurheartj/ehu282. Epub 2014 Aug 1. No abstract available.
- Derived from this study: PubMed 34711333Wanner PM, Wulff DU, Djurdjevic M, Korte W, Schnider TW, Filipovic M. Targeting Higher Intraoperative Blood Pressures Does Not Reduce Adverse Cardiovascular Events Following Noncardiac Surgery. J Am Coll Cardiol. 2021 Nov 2;78(18):1753-1764. doi: 10.1016/j.jacc.2021.08.048.
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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.
Miodrag Filipovic, Prof. Dr. principal investigator
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liberal blood pressure management and Tight blood pressure management in people with Hypotension and Postoperative Complications, run by Miodrag Filipovic, Prof. Dr. med. at 1 site in Switzerland.
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 19 inclusion and 12 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 15 Jul 2020. 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 Switzerland. 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. Some participants in this study may receive a placebo. 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?
High-sensitivity cardiac Troponin I (hs-cTnI) > 0.04ng/ml and >= 35% relative increase compared to preoperative value (time frame: Postoperative days 0-3). The study lists 2 primary outcomes in all. 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 NCT02533128, which also lists 5 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 15 Jul 2020.