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

Sponsor:

Information provided by:

University of Sao Paulo

Study Description

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.

Condition or disease
Left Ventricular Dysfunction Coronary Artery Bypass Surgery Tissue Hypoperfusion

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.

Study Design


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Coronary Artery Bypass Surgery

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Clinical course complicated course group (death within 30 days after surgery or ICU stay > 4 days) and uncomplicated course group (ICU stay ≤ 4 days).

Outcome Measures

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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
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:

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. Epub 2002 Feb 8.

Ranucci M, De Toffol B, Isgrò G, Romitti F, Conti D, Vicentini M. Hyperlactatemia during cardiopulmonary bypass: determinants and impact on postoperative outcome. Crit Care. 2006;10(6):R167.

Ranucci M, Isgrò 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.

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. Epub 2004 Jan 12.

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.


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

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