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Biomarkers, Blood Pressure, BIS: Risk Stratification/Management of Patients at Cardiac Risk in Major Noncardiac Surgery (BBB)

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ClinicalTrials.gov Identifier: NCT02533128
Recruitment Status : Recruiting
First Posted : August 26, 2015
Last Update Posted : February 5, 2018
Sponsor:
Information provided by (Responsible Party):
Miodrag Filipovic, Prof. Dr. med., Cantonal Hospital of St. Gallen

Brief 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 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.


Condition or disease Intervention/treatment Phase
Hypotension Postoperative Complications Acute Coronary Syndrome Heart Failure Coronary Occlusion Stroke Acute Kidney Injury Renal Insufficiency, Chronic Death Drug: Liberal blood pressure management Drug: Tight blood pressure management Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 458 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Study Start Date : September 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : February 2020

Arm Intervention/treatment
Placebo Comparator: Liberal blood pressure management Drug: Liberal blood pressure management
Protocolized hemodynamic management to maintain mean arterial pressure (MAP) > 60 mmHg

Active Comparator: Tight blood pressure management Drug: Tight blood pressure management
Protocolized hemodynamic management to maintain mean arterial pressure (MAP) > 75 mmHg




Primary Outcome Measures :
  1. High-sensitivity cardiac Troponin I (hs-cTnI) > 0.04ng/ml and >= 35% relative increase compared to preoperative value [ Time Frame: Postoperative days 0-3 ]
  2. 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


Secondary Outcome Measures :
  1. Major adverse cardiovascular events [ Time Frame: 1 year postoperatively ]
    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



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (both A and B fulfilled):

  • 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:

    • 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

Exclusion Criteria:

  • 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
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02533128


Contacts
Contact: Miodrag Filipovic, Prof. Dr. +4171 494 1505 miodrag.filipovic@kssg.ch

Locations
Switzerland
Kantonsspital St. Gallen Recruiting
St. Gallen, Switzerland, 9007
Contact: Miodrag Filipovic, Prof. Dr. med.    +4171 494 1505    miodrag.filipovic@kssg.ch   
Sponsors and Collaborators
Miodrag Filipovic, Prof. Dr. med.
Investigators
Principal Investigator: Miodrag Filipovic, Prof. Dr. Cantonal Hospital of St. Gallen

Publications:
Fleisher 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. Epub 2007 Sep 27. Erratum in: Circulation. 2008 Feb 5;117(5):e154. Circulation. 2008 Aug 26;118(9): e143-4.

Responsible Party: Miodrag Filipovic, Prof. Dr. med., Vice-Chairman, Clinic for Anesthesiology, Intensive Care, Prehospital and Pain Medicine, Cantonal Hospital of St. Gallen
ClinicalTrials.gov Identifier: NCT02533128     History of Changes
Other Study ID Numbers: EKSG 15/003
First Posted: August 26, 2015    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018

Keywords provided by Miodrag Filipovic, Prof. Dr. med., Cantonal Hospital of St. Gallen:
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)

Additional relevant MeSH terms:
Heart Failure
Acute Coronary Syndrome
Acute Kidney Injury
Hypotension
Renal Insufficiency
Postoperative Complications
Renal Insufficiency, Chronic
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Kidney Diseases
Urologic Diseases
Pathologic Processes
Coronary Disease