Congenital Heart Disease in ChildrenNCT05778175
Common Cases in Pediatric Intensive Care in Assuit University Cardiology Institute, a Clinical Audit
An observational study of Congenital Heart Disease in Children, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 30 days to 18 years
- Conditions the study is for
- Congenital Heart Disease in Children
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 15 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days to 18 years
- All sexes
- Child, Adult
Study population: Observational study on the methods of management of the common cases in pediatric cardiac intensive care
Who may be able to join
- All cardiac patients aged from 30 days to 18 years old admitted in the pediatric intensive care Assuit University cardiology Institute within one year
Who cannot join
- Other pediatric cardiac patient admitted in the cardiology unit outside the Intensive care.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed 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) .
- Conditions
- Congenital Heart Disease in Children
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2023
- Study start1 May 2023 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion15 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease in ChildrenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martina Tharwat Attia salama, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05778175
- Sponsor's protocol ID
- Clinical audit on Cardiac ICU
- Status last verified
- Mar 2023
- First submitted
- 5 Mar 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 8080468Reddy 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.
PubMed 30511598
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Common Cases in Pediatric Intensive Care in Assuit University Cardiology Institute, a Clinical Audit
- ClinicalTrials.gov ID
- NCT05778175
- Acronym / sponsor ID
- Clinical audit on Cardiac ICU
- Conditions
- Congenital Heart Disease in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 15 Jul 2024 (estimated)
- First posted
- 21 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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) .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 days to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Observational study on the methods of management of the common cases in pediatric cardiac intensive care
Key inclusion criteria (1 listed)
- All cardiac patients aged from 30 days to 18 years old admitted in the pediatric intensive care Assuit University cardiology Institute within one year
Key exclusion criteria (1 listed)
- Other pediatric cardiac patient admitted in the cardiology unit outside the Intensive care.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Common cases in Pediatric Intensive care in Assuit University Cardiology Institute, a clinical audit
Time frame: Baseline
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Background: PubMed 8080468Guidelines 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.
- Background: PubMed 30511598Reddy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease in Children, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martina Tharwat Attia salama (01270735221, martinasarwat2020@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common cases in Pediatric Intensive care in Assuit University Cardiology Institute, a clinical audit (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05778175, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.