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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04275544
Other study ID # KY20200121-C-1
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date February 2020
Est. completion date June 2020

Study information

Verified date February 2020
Source Xijing Hospital
Contact Chong Lei, MD, Ph.D
Phone 86-29-84775343
Email leichongbb@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Xijing Hospital Xi'an Shaanxi

Sponsors (1)

Lead Sponsor Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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Outcome

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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