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OpenTrials
Completed

NCT Number: NCT01178866

Laboratory Outcome Predictors in Coronary Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heart Institute, Hospital of Clinics, São Paulo University Medical School

São Paulo, 05403-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Markers of Tissue Perfusion as Predictors of Complicated Evolution in Patients With Left Ventricular Dysfunction Submitted to Coronary Artery Bypass Surgery

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Aug 10, 2010
Registry last updated
Aug 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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