- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01178866
Laboratory Outcome Predictors in Coronary Surgery
Markers of Tissue Perfusion as Predictors of Complicated Evolution in Patients With Left Ventricular Dysfunction Submitted to Coronary Artery Bypass Surgery
연구 개요
상세 설명
Patients with left ventricular dysfunction are more susceptible to tissue hypoperfusion and presents more frequently both low cardiac output syndrome and systemic inflammatory response, what results in prolonged stay in intensive care unit (ICU), and higher mortality rates when compared to patients with normal ventricular function.
The early prediction of prolonged ICU stay through the detection of tissue hypoperfusion may improve the management of care and decrease morbidity of this particular group of patients. However, classic markers of tissue hypoxia as central venous saturation, base excess, lactate may not be predictors of outcome in cardiac surgery patients with left ventricular dysfunction.
The question addressed in this study is if less employed markers of tissue hypoperfusion as as venoarterial carbon dioxide partial pressure difference (ΔPCO2) and estimated respiratory quotient (eRQ) have predictive value of prolonged ICU stay in patients with left ventricular dysfunction submitted to coronary artery bypass surgery.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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São Paulo, 브라질, 05403-000
- Heart Institute, Hospital of Clinics, São Paulo University Medical School
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- adults
- left ventricular dysfunction (ejection fraction < 50%)
- patients undergoing coronary artery bypass surgery requiring the use of Cardiopulmonary Bypass (CPB)
Exclusion Criteria:
- renal failure (creatinine clearance lower than 40 ml/min/m2),
- hepatic dysfunction
- endocrinologic disorders
- pulmonary disease
- uncontrolled diabetes mellitus
- a history of fever or infection within the week before surgery
- previous anemia (hemoglobin ≤ 10.0 g/dL)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Clinical course
complicated course group (death within 30 days after surgery or ICU stay > 4 days) and uncomplicated course group (ICU stay ≤ 4 days).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Complicated clinical course after coronary artery bypass surgery
기간: within the first 30 days after surgery
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Complicated clinical course defined as death within the first 30 days after surgery or ICU stay more than 4 days.
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within the first 30 days after surgery
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공동 작업자 및 조사자
수사관
- 수석 연구원: Thiana Yamaguti, PhD, Heart Institute, Hospital of Clinics, São Paulo University Medical School
- 연구 의자: José Otávio C. Auler Júnior, PhD/Chairman, Heart Institute, Hospital of Clinics, São Paulo University Medical School
- 연구 책임자: Marilde A. Piccioni, PhD, Heart Institute, Hospital of Clinics, São Paulo University Medical School
간행물 및 유용한 링크
일반 간행물
- Mekontso-Dessap A, Castelain V, Anguel N, Bahloul M, Schauvliege F, Richard C, Teboul JL. Combination of venoarterial PCO2 difference with arteriovenous O2 content difference to detect anaerobic metabolism in patients. Intensive Care Med. 2002 Mar;28(3):272-7. doi: 10.1007/s00134-002-1215-8. Epub 2002 Feb 8.
- Ranucci M, De Toffol B, Isgro G, Romitti F, Conti D, Vicentini M. Hyperlactatemia during cardiopulmonary bypass: determinants and impact on postoperative outcome. Crit Care. 2006;10(6):R167. doi: 10.1186/cc5113.
- Ranucci M, Isgro G, Romitti F, Mele S, Biagioli B, Giomarelli P. Anaerobic metabolism during cardiopulmonary bypass: predictive value of carbon dioxide derived parameters. Ann Thorac Surg. 2006 Jun;81(6):2189-95. doi: 10.1016/j.athoracsur.2006.01.025.
- Meregalli A, Oliveira RP, Friedman G. Occult hypoperfusion is associated with increased mortality in hemodynamically stable, high-risk, surgical patients. Crit Care. 2004 Apr;8(2):R60-5. doi: 10.1186/cc2423. Epub 2004 Jan 12.
- Topkara VK, Cheema FH, Kesavaramanujam S, Mercando ML, Cheema AF, Namerow PB, Argenziano M, Naka Y, Oz MC, Esrig BC. Coronary artery bypass grafting in patients with low ejection fraction. Circulation. 2005 Aug 30;112(9 Suppl):I344-50. doi: 10.1161/CIRCULATIONAHA.104.526277.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .