- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02143544
Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery (IABCS)
Intra-aortic Balloon Counterpulsation in Patients Undergoing Cardiac Surgery: a Randomized Controlled Trial
연구 개요
상세 설명
High-risk patients undergoing cardiac surgery are at high risk for myocardial ischemia, arrhythmia, cardiogenic shock and other clinical complications. Different therapeutic options are available to support these patients in the perioperative period including inotropes, vasopressors, and vasodilators, and also assist devices such as intra-aortic balloon pump (IABP) and others.
IABP increases myocardial oxygen supply by increasing diastolic coronary perfusion pressure and decreases myocardial oxygen demand by reducing left ventricular afterload. Additionally, IABP can also improve cardiac output and systemic perfusion. The hypothesis of this randomized and controlled trial is that the placement of IABP immediately before the cardiac surgery reduces clinical complications in high-risk patients.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ludhmila A Hajjar, PhD
- 전화번호: 11-26625232
- 이메일: ludhmila@usp.br
연구 연락처 백업
- 이름: Graziela Ferreira, Dr
- 전화번호: 11-26615367
- 이메일: gsrf@uol.com.br
연구 장소
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SP
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Sao Paulo, SP, 브라질, 05403000
- 모병
- Heart Institute
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연락하다:
- Graziela Ferreira, Dr
- 전화번호: 11-26615367
- 이메일: gsrf@uol.com.br
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연락하다:
- Ludhmila A Hajjar, PhD
- 전화번호: 11-26615232
- 이메일: ludhmila@usp.br
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수석 연구원:
- Ludhmila A Hajjar, PhD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Age equal to or higher than 18 years old
- EuroSCORE equal to or higher than 6 or ejection fraction equal to or lower than 40%
- Written informed consent
Exclusion Criteria:
- Cardiogenic shock
- Acute myocardial infarction (AMI) < 48 hours
- Mechanical complications of AMI
- Peripheral vascular disease (aorta, iliac or femoral)
- Severe aortic regurgitation
- Neoplasm
- Pregnancy
- Tachyarrhythmia
- Procedures of the aorta
- Coagulopathy
- Thrombocytopenia
- Cardiac transplantation, congenital heart disease or endocarditis
- Refusal to consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Preoperative intra-aortic balloon pump.
Intervention: Preoperative placement of the intra-aortic balloon pump.
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Preoperative placement of the intra-aortic balloon pump.
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간섭 없음: Control
No preoperative placement of the intra-aortic balloon pump.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Composite 30-day mortality or major morbidity (mechanical ventilation > 24 hours, mediastinitis, surgical reexploration, stroke, cardiogenic shock, acute renal failure)
기간: 30 days
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Composite outcome of 30-day mortality or incidence of patients presenting a major complication according to modified Society of Thoracic Surgeons (STS): mechanical ventilation > 24 hours, deep sternal wound infection/mediastinitis, surgical reexploration, stroke, cardiogenic shock and acute renal failure.
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30 days
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Duration of mechanical ventilation
기간: 30 days
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Number of days during mechanical ventilation.
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30 days
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IABP complications
기간: 30 days
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Number of patients presenting one of the following: lower limb ischemia, mesenteric ischemia or bleeding.
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30 days
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Use of vasoactive agents
기간: 30 days
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Number of days and dose of inotropes and vasopressors.
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30 days
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Evaluation of hemodynamic data
기간: 48 hours
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Comparison of the following hemodynamic data between groups: heart rate, arterial pressure and cardiac output.
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48 hours
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Levels of biomarkers
기간: 7 days
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Comparison of the following biomarker levels between groups: pro-BNP (Brain natriuretic peptide), troponin I and Neutrophil gelatinase-associated lipocalin (NGAL), Heart-type Fatty Acid Binding Protein (H-FABP)
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7 days
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Echocardiographic parameters
기간: 7 days
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Comparison of the following echocardiographic parameters between groups: left ventricular ejection fraction, cardiac output, left ventricular diastolic diameter, left ventricular systolic diameter and wall motion abnormalities.
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7 days
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30-day mortality
기간: 30 days
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Death during hospital stay or death after hospital discharge until 30 days following the procedure
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30 days
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60-days mortality
기간: 60 days
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Death until 60 days following the procedure
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60 days
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1-year mortality
기간: 1 year
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Death until 1 year following the procedure
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1 year
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Costs
기간: 30 days
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Comparison of overall costs between groups.
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30 days
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Acute Kidney Injury
기간: 30 days
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Incidence of acute kidney injury according the Acute Kidney Injury Network (AKIN) classification.
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30 days
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Cardiovascular complications
기간: 30 days
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Arrhythmias or myocardial ischemia within 30 days after randomization
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30 days
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Infectious complications
기간: 30 days
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New infection or septic shock within 30 days after randomization
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30 days
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Delirium
기간: 30 days
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Acute cognitive dysfunction diagnosed with the use of the CAM-ICU scale within 30 days after randomization
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30 days
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Bleeding
기간: 24 hours
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Blood losses exceeding 100-300 mL per hour following ICU admission
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24 hours
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- Caldas JR, Panerai RB, Bor-Seng-Shu E, Ferreira GSR, Camara L, Passos RH, Salinet AM, Azevedo DS, de-Lima-Oliveira M, Galas FRBG, Fukushima JT, Nogueira R, Taccone FS, Landoni G, Almeida JP, Robinson TG, Hajjar LA. Intra-aortic balloon pump does not influence cerebral hemodynamics and neurological outcomes in high-risk cardiac patients undergoing cardiac surgery: an analysis of the IABCS trial. Ann Intensive Care. 2019 Nov 27;9(1):130. doi: 10.1186/s13613-019-0602-z.
- Caldas JR, Panerai RB, Bor-Seng-Shu E, Ferreira GSR, Camara L, Passos RH, de-Lima-Oliveira M, Galas FRBG, Almeida JP, Nogueira RC, Mian N, Gaiotto FA, Robinson TG, Hajjar LA. Dynamic cerebral autoregulation: A marker of post-operative delirium? Clin Neurophysiol. 2019 Jan;130(1):101-108. doi: 10.1016/j.clinph.2018.11.008. Epub 2018 Nov 22.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Heart Institute
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