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Laboratory Outcome Predictors in Coronary Surgery

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01178866
First Posted: August 10, 2010
Last Update Posted: August 10, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Sao Paulo
  Purpose
Evaluate less employed markers of tissue hypoperfusion as venoarterial carbon dioxide partial pressure difference (ΔPCO2) and estimated respiratory quotient (eRQ) combined to other classically studied markers as predictive factors of complicated clinical course after cardiac surgery in patients with left ventricular dysfunction.

Condition
Left Ventricular Dysfunction Coronary Artery Bypass Surgery Tissue Hypoperfusion

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • 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.


Enrollment: 87
Study Start Date: January 2006
Study Completion Date: March 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Clinical course
complicated course group (death within 30 days after surgery or ICU stay > 4 days) and uncomplicated course group (ICU stay ≤ 4 days).

Detailed Description:

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.

  Eligibility

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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
Study Population
Adults undergoing coronary artery bypass surgery requiring the use of CPB
Criteria

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)
  Contacts and Locations
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): NCT01178866


Locations
Brazil
Heart Institute, Hospital of Clinics, São Paulo University Medical School
São Paulo, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
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
  More Information

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 Submitted: August 9, 2010
First Posted: August 10, 2010
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