Clinical trial NCT01178866: Laboratory Outcome Predictors in Coronary Surgery
Official title: Markers of Tissue Perfusion as Predictors of Complicated Evolution in Patients With Left Ventricular Dysfunction Submitted to Coronary Artery Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Dysfunction
Coronary Artery Bypass Surgery
Tissue Hypoperfusion
Keywords: thoracic surgery
myocardial revascularization
left ventricular dysfunction
tissue perfusion
prognosis
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults undergoing coronary artery bypass surgery requiring the use of CPB

Brief summary: 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.

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 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)

Primary outcomes:
measure: Complicated clinical course after coronary artery bypass surgery
timeFrame: within the first 30 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute, Hospital of Clinics, São Paulo University Medical School
Study officials:
affiliation: Heart Institute, Hospital of Clinics, São Paulo University Medical School
name: Thiana Yamaguti, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Institute, Hospital of Clinics, São Paulo University Medical School
name: José Otávio C. Auler Júnior, PhD/Chairman
role: STUDY_CHAIR
affiliation: Heart Institute, Hospital of Clinics, São Paulo University Medical School
name: Marilde A. Piccioni, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.