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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05778175
Other study ID # Clinical audit on Cardiac ICU
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 1, 2023
Est. completion date July 15, 2024

Study information

Verified date March 2023
Source Assiut University
Contact Martina Tharwat Attia salama
Phone 01270735221
Email martinasarwat2020@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1Evaluation of the management methods according to guidelines for cardiac patients admitted to Intensive care in pediatric Assuit university cardiology institute and the effectiveness and outcome of following of these medications comparing them with international advanced centers. Types of shocks in cardiac patients and management of cardiogenic shock needs especial concern.


Description:

Critically ill pediatric patients with cardiac disease such as (cardiogenic Shock, life- threatening arrhythmias, congenital heart diseases with unstable cardiorespiratory status, uncompensated heart failure, after cardiac catheterization and after high risk cardiovascular and intrathoracic procedures) must be admitted to a designated intensive care unit and not discharged untill reversal of the disease process or restoration of the unstable physiologic condition and become hemodynamically stable, cardiac dysrhythmias controlled and there's no need for intravenous inotropic support, vasodilators, and antiarrhythmic drugs or when required, low doses of these medications can be administered safely . Physicians, nurses and other health care providers should perform a regular review of their clinical practice and the activities which carried out relying on established standards and the main purpose of this revision process is to evaluate the efficacy, effectiveness and safety of the provided medical care . Because the number of patients with critical heart diseases is relatively small, there are big knowledge gaps and variation in the methods of management. Presence of a specific Pediatric Cardiac Intensive Care led to correction of this knowledge gap and providing clinicians with Scientific statements and white papers used as a guidance in diagnostic and therapeutic strategies aiming to changing the individual institution-based practices efforts to national standardized protocols which results in a better outcome . Presence of a specific cardiac intensive care unit (CICU) with highly specialized teams with specific knowledge and skills leads to direction of many investigations to provide the highest value care. This has many advantages on the outcome of the admitted patients such as: lower hospital costs, shorter duration of hospital stay and decrease mortality rate . A case of special concern is cardiogenic shock which is an acute state of circulatory failure due to impairment of myocardial contractility and it's the most serious stage of heart failure and a major cause of morbidity and mortality in pediatric cardiac patients, it must be recognized and managed early and any delay in the recognition and management of potential clinical symptoms and signs of compensated shock could lead to a high mortality rate . Recognition of early signs of cardiogenic shock by clinical examination (tachycardia, hypotension, impaired conscious level, fall in oxygen saturation, decreased urine output and respiratory distress) or investigations like as: chest x-ray (cardiomegaly, pulmonary edema), ECG (arrhythmias, conduction disorders, myocardial ischemia),and transthoracic echocardiograms are useful for diagnostic, etiological, therapeutic, and prognostic purposes . Initial management of the cardiogenic shock aiming to restore adequate oxygen delivery to peripheral tissues by oxygen therapy (noninvasive or invasive ventilation) with a saturation objective of >95 % except in cyanotic heart, decrease the circulatory preload by fluid restriction and diuretics, decrease the circulatory afterload by arterial vasodilators, increase the cardiac contractility by inotropes (dopamine, dobutamine and digoxin) and treating curable causes (fluid and electrolyte balance, rhythm, or thromboembolic disorders; pneumothorax, tamponade, infection) .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 95
Est. completion date July 15, 2024
Est. primary completion date May 30, 2024
Accepts healthy volunteers
Gender All
Age group 30 Days to 18 Years
Eligibility Inclusion Criteria: - All cardiac patients aged from 30 days to 18 years old admitted in the pediatric intensive care Assuit University cardiology Institute within one year Exclusion Criteria: - Other pediatric cardiac patient admitted in the cardiology unit outside the Intensive care.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (2)

Guidelines for the transfer of critically ill patients. Guidelines Committee of the American College of Critical Care Medicine; Society of Critical Care Medicine and American Association of Critical-Care Nurses Transfer Guidelines Task Force. Crit Care Med. 1993 Jun;21(6):931-7. — View Citation

Reddy S, Polito A, Staveski S, Dalton H. A process for academic societies to develop scientific statements and white papers: experience of the Pediatric Cardiac Intensive Care Society. Cardiol Young. 2019 Feb;29(2):174-177. doi: 10.1017/S1047951118002019. Epub 2018 Dec 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Common cases in Pediatric Intensive care in Assuit University Cardiology Institute, a clinical audit Evaluation of different methods of management and comparing them with the guidelines of diagnosis and treatment aiming to changing the individual institution-based practices efforts to national standardized protocols which results in a better outcome by a questionnaire. Baseline
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