Laboratory Outcome Predictors in Coronary Surgery

This study has been completed.
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01178866
First received: August 9, 2010
Last updated: NA
Last verified: January 2008
History: No changes posted
  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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 9, 2010
Last Updated: August 9, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
thoracic surgery
myocardial revascularization
left ventricular dysfunction
tissue perfusion
prognosis

Additional relevant MeSH terms:
Ventricular Dysfunction, Left
Ventricular Dysfunction
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014