An observational study in Vasoplegic Syndrome, Vasoplegia and Surgery-Complications, sponsored by University of Sao Paulo General Hospital. Completed at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-10.
Sponsored by University of Sao Paulo General Hospital · Observational
This study looks for a correlation between microRNAs (miRNAs) and vasoplegic syndrome after on-pump coronary artery bypass surgery.
Cardiovascular diseases (CVD) are among the main causes of morbidity and mortality in the world, and in Brazil they account for approximately 31% of all causes of death and 42% of deaths due to noncommunicable diseases. In 2014 were carried out a total number of 92,000 heart surgeries in Brazil and these are usually performed using Cardiopulmonary Bypass (CPB), which is made by the diversion of blood circulation of the lungs and heart to a heart-lung machine, which keeps cardio circulatory functions and oxygenates the blood. Despite enable various types of major cardiac surgery, the use of CPB can cause serious side effects such as post perfusion vasoplegic syndrome (VS). This is characterized by increased cardiac output, hypotension, systemic inflammatory response and decreased vascular resistance, affecting 9-44% of patients in the postoperative period of cardiac surgery, with a mortality of 27%. Treatment to VS are limited and the drugs are often ineffective, including noradrenaline, vasopressin, and methylene blue. Another difficulty encountered by the surgeon is to establish a predictive factor for VS. Systems risk predictors that use score and are well validated as EuroSCORE (European System for Cardiac Operative Risk Evaluation) have not been tested for VS. Much has been studied on the use of biomarkers as predictors and for prognosis as well as to improve predictive power of the rating systems available. MicroRNAs (miRNAs) are noncoding RNA molecules that control gene expression in the intracellular environment and are present circulating in various body fluids including peripheral blood. These molecules can be used as biomarkers of various pathologies including CVD. Despite the existence of numerous studies that demonstrate the importance of miRNAs in the development of CVDs. There are no studies that address the issue in VS. Therefore, the objective of the project is to identify the presence of blood miRNAs that are altered in patients with pre and intra-operative cardiovascular surgery and assess whether these miRNAs can be used as predictors and biomarkers of mortality for VS.
48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.
This study's enrollment of 320 is above the median of 200 across 19 observational studies indexed under Vasoplegia.
Browse Vasoplegia studies →University of Sao Paulo General Hospital is the lead sponsor of 611 studies on the registry; 98 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Our population is build whith both sexy, bigger than 18 years old, who has indication of coronary artery surgery. that was selected.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients undergoing on-pump coronary artery bypass graft who develops vasoplegic syndrome 24 - 48 hours after surgery.
Other: vasoplegic syndrome
Patients undergoing on-pump coronary artery bypass graft who does not develop vasoplegic syndrome.
Other: vasoplegic syndrome
In all included patients, 3 milliliters of venous blood will be collected before cardiopulmonary bypass, 3 milliliters of venous blood 15 minutes after the reversal of heparin with protamine and a small fragment of aortic tissue. Samples of biological material will be compared between the control and vasoplegic groups for the difference in amount and type of miRNA present. For the diagnosis of vasospastic syndrome, the following criteria were adopted: mean arterial pressure \< 65 mmHg, cardiac index \< 2.2 L / min / m2, refractory to replacement of at least 1000 milliliters of crystalloid, excluding other causes such as tamponade, bleeding and cardiogenic shock
Profile of miRNA
Find out if it is possible to use mirna as a predictor of vasoplegic syndrome
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Aug 2017 to primary completion in Dec 2019, 28 months.
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This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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