Laboratory Outcome Predictors in Coronary Surgery
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ClinicalTrials.gov Identifier: NCT01178866 |
Recruitment Status
:
Completed
First Posted
: August 10, 2010
Last Update Posted
: August 10, 2010
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Condition or disease |
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Left Ventricular Dysfunction Coronary Artery Bypass Surgery Tissue Hypoperfusion |
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.
Study Type : | Observational |
Actual Enrollment : | 87 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Markers of Tissue Perfusion as Predictors of Complicated Evolution in Patients With Left Ventricular Dysfunction Submitted to Coronary Artery Bypass Surgery |
Study Start Date : | January 2006 |
Actual Primary Completion Date : | January 2008 |
Actual Study Completion Date : | March 2008 |

Group/Cohort |
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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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- Complicated clinical course after coronary artery bypass surgery [ Time Frame: within the first 30 days after surgery ]Complicated clinical course defined as death within the first 30 days after surgery or ICU stay more than 4 days.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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)

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): NCT01178866
Brazil | |
Heart Institute, Hospital of Clinics, São Paulo University Medical School | |
São Paulo, Brazil, 05403-000 |
Principal Investigator: | Thiana Yamaguti, PhD | Heart Institute, Hospital of Clinics, São Paulo University Medical School | |
Study Chair: | José Otávio C. Auler Júnior, PhD/Chairman | Heart Institute, Hospital of Clinics, São Paulo University Medical School | |
Study Director: | Marilde A. Piccioni, PhD | Heart Institute, Hospital of Clinics, São Paulo University Medical School |
Publications:
Responsible Party: | Thiana Yamaguti/ Médica assistente da divisão de anestesiologia do InCor - HCFMUSP, University of Sao Paulo |
ClinicalTrials.gov Identifier: | NCT01178866 History of Changes |
Other Study ID Numbers: |
HC517/04 |
First Posted: | August 10, 2010 Key Record Dates |
Last Update Posted: | August 10, 2010 |
Last Verified: | January 2008 |
Keywords provided by University of Sao Paulo:
thoracic surgery myocardial revascularization left ventricular dysfunction tissue perfusion prognosis |
Additional relevant MeSH terms:
Ventricular Dysfunction Ventricular Dysfunction, Left Heart Diseases Cardiovascular Diseases |