Risk Factors of Postoperative Complications in HCM Patients (RFHCM)

February 15, 2020 updated by: chonglei, Xijing Hospital

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

This study is a single center retrospective observational study 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.

Ethical approval of this study was obtained from the Institutional Review Board of the investigators' hospital (No. KY20192036-C-1). The requirement for written informed consent was waived by the Institutional Review Board, considering the retrospective nature of the study.

Retrospective chart review will identify adult HOCM patients who underwent septal myectomy from October 2013 to December 2018 in the investigators' hospital. The clinical diagnosis of HOCM is made by echocardiography, cardiac magnetic resonance imaging, or computed tomography of a hypertrophied, non-dilated LV, in the absence of cardiac or systemic disease that can aggravate the magnitude of hypertrophy.

Data Collection

The following data will be collected. Data will be obtained from electronic medical records and collected by two trained staff who are unaware of the purpose of the study.

  1. Demographic and clinical data included New York Heart Association class, family history of hypertrophic cardiomyopathy (HCM) and sudden death, patient history, symptoms, medications, and comorbidities of these enrolled patients.
  2. The following preoperative echocardiographic parameters will be collected : left atrium diameter, left ventricular (LV) ejection fraction (EF), maximal LV wall thickness (defined as the greatest thickness measured at any site within the LV wall), maximal interventricular septal thickness, left ventricular outflow tract diameter (LVOTd) (C-sept distance, the shortest distance from the septum to the coaptation point of the mitral valve), and resting left ventricular outflow tract (LVOT) gradient (measured with continuous-wave Doppler in the apical five-chamber view using the modified Bernoulli equation).
  3. 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 and intraoperative fluid balance (total intraoperative fluid intake is calculated as the sum of crystalloid, colloid and blood products; total output was calculated as the sum of the volumes of estimated blood loss and urine output; intraoperative fluid balance is calculated by subtracting the total output from the total fluid intake); and blood pressure parameters including the baseline mean arterial pressure and lowest mean arterial pressure, and duration of intraoperative hypotension (intraoperative hypotension is defined as a mean arterial pressure <65 mmHg).
  4. Postoperative ventilation hours, lengths of stay in the intensive care unit (ICU) and hospital, blood transfusion in 72 hours after surgery, EF, LVOTd, resting LVOT gradient gradient, and in-hospital PCs will also be obtained. 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.

Statistical analysis

Continuous variables will be expressed as mean ± standard deviation (SD) or median (interquartile range). Differences of continuous variables will be analysed by using a parametric unpaired Student's t-test or non-parametric Mann-Whitney U-test, as appropriate. Categorical variables will be described as percentages (%) and compared using the chi-square test or Fisher's exact test. For all analyses, a two-tailed P-value <0.05 will be considered statistically significant. The multivariable model will be used to determine independent predictors by including only variables that are identified by univariable analysis as significant prognosis risk factors with a P-value <0.05. Receiver operating characteristic curve will be used to calculate the cut off values of individual risk factors. The predictive ability of individual predictor and different combination of multiple risk factors on PCs will also be calculated. SPSS software version 22.0 (IBM Corp., Armonk, NY, USA) will be used to analyse the data.

Privacy

All data collected in this study will be stored on computer systems that require user authentication for log on. After data collection is complete, none of this electronic data will be stored with subject-identifying information and will be archived and kept indefinitely.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 98 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a confirmed clinical diagnosis of HOCM were referred for surgical septal myectomy in a tertiary hospital in China

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Patients with PCs

HOCM Patients developing postoperative complications (PCs) following septal myectomy.

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.
Patients without PCs
HOCM Patients do not develope postoperative complications following septal myectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identify perioperative risk factors of in-hospital postoperative complications (PCs)
Time Frame: From the surgery start to patient discharge from hospital, normally within 20 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of in-hospital postoperative complications (PCs)
Time Frame: From the end of surgery to patient discharged from hospital, normally within 20 days
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital-stay
Time Frame: During patient stay in hospital, normally within 30 days
The number of days patient stay in hospital
During patient stay in hospital, normally within 30 days
ICU-stay
Time Frame: From the end of surgery to patient discharged from ICU, normally within 10 days
The number of days patient stay in ICU after surgery
From the end of surgery to patient discharged from ICU, normally within 10 days
Postoperative mechanical ventilation
Time Frame: From the end of surgery to tracheal extubation, normally within 48 hours
Duation of postoperative mechanical ventilation
From the end of surgery to tracheal extubation, normally within 48 hours
Postoperative hospital stay
Time Frame: From the end of surgery to patient discharged from hospital, normally within 20 days
Length of postoperative hospital stay
From the end of surgery to patient discharged from hospital, normally within 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Director: Hailong Dong, MD, Ph.D, Director of the Department of Anesthesiology and Perioperative Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 1, 2020

Primary Completion (Anticipated)

May 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

February 11, 2020

First Submitted That Met QC Criteria

February 15, 2020

First Posted (Actual)

February 19, 2020

Study Record Updates

Last Update Posted (Actual)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 15, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20200121-C-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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