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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05985720
Other study ID # Asthmatic children
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 2023
Est. completion date April 2024

Study information

Verified date July 2023
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Evaluation of cardiac biomarkers and the left and right ventricular systolic and diastolic function in asthmatic children in Assuit university hospital


Description:

Severe acute asthma which is defined asthma that is uncontrolled despite maximal optimized therapy and treatment of contributory factors, or that worsens when high dose treatment is decreased(1) and it is characterized by severe respiratory distress because of increasing bronchoconstriction, leading to ventilation perfusion mismatch, hypoxia, respiratory muscle fatigue, carbon dioxide retention and respiratory acidosis(2) In acute severe asthma, the use of beta 2 agonists, together with hypoxia and tachycardia might cause increased myocardial workload further leading to myocardial infarction(3). Cardiac biomarkers including Brain Natriuretic Peptide (BNP),Troponin I (TnI) and Creatine kinase muscle/brain(CK-MB) are used to detect myocardial injury(4). The objective of the present study was to find out the incidence of myocardial dysfunction in patients of acute severe bronchial asthma based on cardiac biomarker levels at admission and to see whether the myocardial dysfunction was transient or persistent even after the stabilization of the patient. As far as it could be reviewed, no study relating BNP levels in pediatric asthma patients could be found in literature. Echocardiographic changes in bronchial asthma regarding RT ventricular and Ltventricular function will be assessed According to some studies right ventricular (RV) systolic and diastolic dysfunction were detected, even in mild cases, by echocardiography. On the other hand, left ventricular (LV) dysfunction usually presents itself in severe asthmatic cases which may be reversible in acute conditions (5). Some studies showed that there were no differences in echocardiographic findings regarding the ventricular function with the exception of RV wall thickness (6). Asthma affects ventricular contractility in children. Although cardiac systolic function was found to be impaired in asthmatic patients, contrary to the literature diastolic dysfunction didn't observed in these patients even by tissue Doppler imaging, may be due to using inhaled corticosteroid(7). This was one of the most comprehensive studies among asthmatic patients. Further studies with larger sample sizes or without using corticosteroid treatment war ranted to better elucidate the cardiac function.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 5 Years to 15 Years
Eligibility Inclusion Criteria: - all pediatric cases between the age of 5 -15years with acute severe bronchial asthma who were admitted in pediatric emergency care unit Exclusion Criteria: - Children with congenital or acquired heart diseases - Foreign body aspiration . - Chest infections - Tuberculosis or pneumonia

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

Peng SM, Sun P, Zeng J, Deng XM. [Cardiac function of children with bronchial asthma]. Zhongguo Dang Dai Er Ke Za Zhi. 2006 Oct;8(5):388-90. Chinese. — View Citation

Rodriguez-Roisin R, Ballester E, Roca J, Torres A, Wagner PD. Mechanisms of hypoxemia in patients with status asthmaticus requiring mechanical ventilation. Am Rev Respir Dis. 1989 Mar;139(3):732-9. doi: 10.1164/ajrccm/139.3.732. — View Citation

Sears MR. Trends in the prevalence of asthma. Chest. 2014 Feb;145(2):219-225. doi: 10.1378/chest.13-2059. — View Citation

Shedeed SA. Right ventricular function in children with bronchial asthma: a tissue Doppler echocardiographic study. Pediatr Cardiol. 2010 Oct;31(7):1008-15. doi: 10.1007/s00246-010-9753-2. Epub 2010 Aug 10. — View Citation

Zeybek C, Yalcin Y, Erdem A, Polat TB, Aktuglu-Zeybek AC, Bayoglu V, Akdeniz C, Celebi A. Tissue Doppler echocardiographic assessment of cardiac function in children with bronchial asthma. Pediatr Int. 2007 Dec;49(6):911-7. doi: 10.1111/j.1442-200X.2007.02486.x. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other to identify the relation between asthmatic children and child weight relation between asthma outcome and patient wieght Baseline
Primary to identify the relation between asthmatic children and cardiac function relation between asthma and cardiac function Baseline
Primary to identify the relation between asthmatic children and myocardial dysfunction relation between asthma and myocardial dysfunction Baseline
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