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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Martina Tharwat Attia salama contact

01270735221

martinasarwat2020@gmail.com

khaled Abd elaziz Sanousy contact

01003068421

Khalidelsanousy@yahoo.com

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) .

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted21 Mar 2023
  2. Study start1 May 2023 (estimated)
  3. Primary completion30 May 2024 (estimated)
  4. Study completion15 Jul 2024 (estimated)

Resources

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)
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 8080468
  • 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.

    PubMed 30511598

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.

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