Left Ventricular DysfunctionNCT01178866
Laboratory Outcome Predictors in Coronary Surgery
An observational study of Left Ventricular Dysfunction and Coronary Artery Bypass Surgery, run by University of Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Dysfunction, Coronary Artery Bypass Surgery, Tissue Hypoperfusion
- How many people
- 87 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2006to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults undergoing coronary artery bypass surgery requiring the use of CPB
Who may be able to join
- adults
- left ventricular dysfunction (ejection fraction < 50%)
- patients undergoing coronary artery bypass surgery requiring the use of Cardiopulmonary Bypass (CPB)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Heart Institute, Hospital of Clinics, São Paulo University Medical School
São Paulo, São Paulo, 05403-000
About this study
Official title: Markers of Tissue Perfusion as Predictors of Complicated Evolution in Patients With Left Ventricular Dysfunction Submitted to Coronary Artery Bypass 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.
Read the 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.
- Keywords
- thoracic surgery, myocardial revascularization, left ventricular dysfunction, tissue perfusion, prognosis
- Medical subject headings
- Ventricular Dysfunction, Left
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinical course | complicated course group (death within 30 days after surgery or ICU stay > 4 days) and uncomplicated course group (ICU stay ≤ 4 days). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complicated clinical course after coronary artery bypass surgery
Complicated clinical course defined as death within the first 30 days after surgery or ICU stay more than 4 days.
Measured: within the first 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startJan 2006
- Primary completionJan 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular DysfunctionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Investigators
- Thiana Yamaguti, PhD, Principal investigator, Heart Institute, Hospital of Clinics, São Paulo University Medical SchoolJosé Otávio C. Auler Júnior, PhD/Chairman, Study chair, Heart Institute, Hospital of Clinics, São Paulo University Medical SchoolMarilde A. Piccioni, PhD, Study director, Heart Institute, Hospital of Clinics, São Paulo University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178866
- Sponsor's protocol ID
- HC517/04
- Status last verified
- Jan 2008
- First submitted
- 9 Aug 2010
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1007/s00134-002-1215-8. Epub 2002 Feb 8.
PubMed 11904655Ranucci 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.
PubMed 17134504Ranucci 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.
PubMed 16731152Meregalli 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.
PubMed 15025779Topkara 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.
PubMed 16159844
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Markers of Tissue Perfusion as Predictors of Complicated Evolution in Patients With Left Ventricular Dysfunction Submitted to Coronary Artery Bypass Surgery
- ClinicalTrials.gov ID
- NCT01178866
- Acronym / sponsor ID
- HC517/04
- Keywords
- thoracic surgery, myocardial revascularization, left ventricular dysfunction, tissue perfusion, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Jan 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 10 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical course | – | –complicated course group (death within 30 days after surgery or ICU stay > 4 days) and uncomplicated course group (ICU stay ≤ 4 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults undergoing coronary artery bypass surgery requiring the use of CPB
Key inclusion criteria (3 listed)
- adults
- left ventricular dysfunction (ejection fraction < 50%)
- patients undergoing coronary artery bypass surgery requiring the use of Cardiopulmonary Bypass (CPB)
Key exclusion criteria (7 listed)
- renal failure (creatinine clearance lower than 40 ml/min/m2),
- hepatic dysfunction
- endocrinologic disorders
- pulmonary disease
- uncontrolled diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
- Background: PubMed 11904655Mekontso-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.
- Background: PubMed 17134504Ranucci 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.
- Background: PubMed 16731152Ranucci 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.
- Background: PubMed 15025779Meregalli 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.
- Background: PubMed 16159844Topkara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thiana Yamaguti, PhD principal investigator
Heart Institute, Hospital of Clinics, São Paulo University Medical School
José Otávio C. Auler Júnior, PhD/Chairman study chair
Heart Institute, Hospital of Clinics, São Paulo University Medical School
Marilde A. Piccioni, PhD study director
Heart Institute, Hospital of Clinics, São Paulo University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Left Ventricular Dysfunction and Coronary Artery Bypass Surgery, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complicated clinical course after coronary artery bypass surgery (time frame: within the first 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01178866, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.