Hypertrophic Obstructive Cardiomyopathy Clinical Trial
— RFHCMOfficial title:
Perioperative Risk Factors of Postoperative Complications in Hypertrophic Obstructive Cardiomyopathy Patients Undergoing Septal Myectomy
Perioperative management may have strong connections with postoperative complications (PCs). However, little is known about the perioperative risk factors of PCs after septal myectomy in hypertrophic obstructive cardiomyopathy (HOCM) patients. This study is designed to assess the in-hospital PCs rate of HOCM patients and to identify perioperative risk factors of PCs in patients who underwent septal myectomy. Retrospective chart review will identify adult HOCM patients who underwent septal myectomy from October 2013 to December 2018 in the investigators' hospital. Patients' data will be collected from electronic medical records. The multivariable logistic regression analysis will be used to determine independent predictors. The predictive ability of individual predictor and different combination of multiple risk factors on PCs will also be calculated.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | June 2020 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility |
Inclusion Criteria: - Adult patients =18 years of age who underwent thoracotomy for septal myectomy. Exclusion Criteria: - Patients with severe liver and renal disease, severe central nervous system disease, malignancy, defibrillators and age under 18 years old |
Country | Name | City | State |
---|---|---|---|
China | Xijing Hospital | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital |
China,
Authors/Task Force members, Elliott PM, Anastasakis A, Borger MA, Borggrefe M, Cecchi F, Charron P, Hagege AA, Lafont A, Limongelli G, Mahrholdt H, McKenna WJ, Mogensen J, Nihoyannopoulos P, Nistri S, Pieper PG, Pieske B, Rapezzi C, Rutten FH, Tillmanns C, Watkins H. 2014 ESC Guidelines on diagnosis and management of hypertrophic cardiomyopathy: the Task Force for the Diagnosis and Management of Hypertrophic Cardiomyopathy of the European Society of Cardiology (ESC). Eur Heart J. 2014 Oct 14;35(39):2733-79. doi: 10.1093/eurheartj/ehu284. Epub 2014 Aug 29. — View Citation
Brown ML, Schaff HV. Surgical management of obstructive hypertrophic cardiomyopathy: the gold standard. Expert Rev Cardiovasc Ther. 2008 Jun;6(5):715-22. doi: 10.1586/14779072.6.5.715. Review. — View Citation
Desai MY, Bhonsale A, Smedira NG, Naji P, Thamilarasan M, Lytle BW, Lever HM. Predictors of long-term outcomes in symptomatic hypertrophic obstructive cardiomyopathy patients undergoing surgical relief of left ventricular outflow tract obstruction. Circulation. 2013 Jul 16;128(3):209-16. doi: 10.1161/CIRCULATIONAHA.112.000849. Epub 2013 Jun 14. — View Citation
Parry DJ, Raskin RE, Poynter JA, Ribero IB, Bajona P, Rakowski H, Woo A, Ralph-Edwards A. Short and medium term outcomes of surgery for patients with hypertrophic obstructive cardiomyopathy. Ann Thorac Surg. 2015 Apr;99(4):1213-9. doi: 10.1016/j.athoracsur.2014.11.020. Epub 2015 Feb 10. — View Citation
Tang B, Song Y, Cui H, Ji K, Zhu C, Zhao S, Huang X, Yu Q, Hu S, Wang S. Prediction of Mid-Term Outcomes in Adult Obstructive Hypertrophic Cardiomyopathy After Surgical Ventricular Septum Myectomy. J Am Coll Cardiol. 2017 Oct 17;70(16):2092-2094. doi: 10.1016/j.jacc.2017.08.032. — View Citation
Woo A, Williams WG, Choi R, Wigle ED, Rozenblyum E, Fedwick K, Siu S, Ralph-Edwards A, Rakowski H. Clinical and echocardiographic determinants of long-term survival after surgical myectomy in obstructive hypertrophic cardiomyopathy. Circulation. 2005 Apr 26;111(16):2033-41. Epub 2005 Apr 11. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Hospital-stay | The number of days patient stay in hospital | During patient stay in hospital, normally within 30 days | |
Other | ICU-stay | The number of days patient stay in ICU after surgery | From the end of surgery to patient discharged from ICU, normally within 10 days | |
Other | Postoperative mechanical ventilation | Duation of postoperative mechanical ventilation | From the end of surgery to tracheal extubation, normally within 48 hours | |
Other | Postoperative hospital stay | Length of postoperative hospital stay | From the end of surgery to patient discharged from hospital, normally within 20 days | |
Primary | Identify perioperative risk factors of in-hospital postoperative complications (PCs) | Identify the perioperative risk factors of in-hospital PCs by multivariable logistic regression analysis. Intraoperative data collected include the duration of anaesthesia, surgery, CPB, and cross-clamp; excised LV weight; type of concomitant procedure; lowest body temperature, haematocrit , haemoglobin and highest Lactic acid; perioperative fluid management including the volumes of total fluid intake, total output, blood loss and urine output; and blood pressure parameters including the baseline mean arterial pressure and lowest mean arterial pressure, and duration of intraoperative hypotension (intraoperative hypotension was defined as a mean arterial pressure <65 mmHg). In-hospital PCs include all cause mortality, heart failure, low cardiac output syndrome, stroke, spinal cord injury, acute respiratory distress syndrome, reintubation, reoperation, permanent implantable cardioverter defibrillator, kidney injury, renal failure, liver injury, and liver failure. |
From the surgery start to patient discharge from hospital, normally within 20 days | |
Secondary | The incidence of in-hospital postoperative complications (PCs) | In-hospital PCs include all cause mortality, heart failure, low cardiac output syndrome, stroke, spinal cord injury, acute respiratory distress syndrome, reintubation, reoperation, permanent implantable cardioverter defibrillator, kidney injury, renal failure, liver injury, and liver failure. | From the end of surgery to patient discharged from hospital, normally within 20 days |
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