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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05442385
Other study ID # cardiac patient in PICU
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 1, 2022
Est. completion date September 1, 2023

Study information

Verified date June 2022
Source Assiut University
Contact Mina refaet, resident
Phone 01013491003
Email mena.20134402@med.aun.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Aim of the work: To describe the clinical patterns criteria of infants and children with cardiac disease admitted to PICU and their outcome.


Description:

Intensive care has become very important in the management of critically ill children. The pediatric intensive care unit (PICU) is a part of the hospital where critically ill pediatric patients who require advanced airway, respiratory, and hemodynamic supports are usually admitted with the aim of achieving an outcome better than if the patients were admitted into other parts of the hospital. The care of critically ill children remains one of the most demanding and challenging aspects of the field of pediatrics. The main purpose of the PICU is to prevent mortality by intensively monitoring and treating critically ill children who are considered at high risk of mortality. This, however, comes at a huge cost to all the parties involved the hospital, the personnel, and the care givers of patients. It is usually only offered to patients whose condition is potentially reversible and who have a good chance of surviving with intensive care support. Since these patients are critically ill, the outcome of intervention is sometimes difficult to predict. In critical care medicine, intensive care unit (ICU) results can be assessed on the basis of outcomes such as "death" or "survival" by means of indicators such as mortality rates. Evaluation of the outcomes of medical interventions can assess the efficacy of treatment, making it possible to take better decisions, to further improve quality of care, to standardize conduct, and to ensure effective management of the high-level resources needed to deliver intensive care services thereby optimizing resource utilization. Although mortality in patients depends on many factors such as demographic and clinical characteristic of population, infrastructure and non-medical factors (management and organization), case mix, and admission practice, it is also affected by ICU performance. The PICU concept was initially developed about 40 years ago with the first consensus conference on critical care admission held in 1983 by the National Institute of Health in the US The principle that emerged from this group continues to be relevant even today as it identifies patients who should be admitted to the PICU as those who "reversible medical conditions with a reasonable prospect of substantial recovery" Clinical diagnosis model based PICU admission criteria Cardiac conditions cardiogenic shock, myocardial dysfunction: infectious and other complex dysrhythmias requiring close monitoring and intervention, including new onset complete heart block and after cardioversion, acute congestive heart failure requiring hemodynamic support, hypertensive emergencies after cardiac arrest and post-resuscitation, aortic dissection congenital heart disease with cardiopulmonary instability patients presenting to the emergency department with cardiorespiratory or neurologic compromise after high risk intrathoracic or cardiac procedures, need for invasive cardiac monitoring, need for cardiac pacing, pericardial effusion requiring drainage, signs of tamponade ,hypertensive urgency. Thus it is very important to have clear time sensitive goals in ICU management of these fragile infants and children to minimize mortality and neuromorbidity


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 72
Est. completion date September 1, 2023
Est. primary completion date August 1, 2023
Accepts healthy volunteers No
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria: 1. Infants and children aged 1 month to 18 years. 2. Patients with primary cardiac diseases either congenital heart disease such VSD or acquired heart disease like rheumatic heart disease and heart failure Admitted to ICU Exclusion Criteria: pediatric patient without cardiac diseases

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Evidence based management
clinical patterns , laboratory investigations , radiology , lines of managements and outcome of each modality of treatment

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (11)

Bertolini G, Ripamonti D, Cattaneo A, Apolone G. Pediatric risk of mortality: an assessment of its performance in a sample of 26 Italian intensive care units. Crit Care Med. 1998 Aug;26(8):1427-32. — View Citation

Bone RC, McElwee NE, Eubanks DH, Gluck EH. Analysis of indications for intensive care unit admission. Clinical efficacy assessment project: American College of Physicians. Chest. 1993 Dec;104(6):1806-11. — View Citation

Carcillo JA, Kuch BA, Han YY, Day S, Greenwald BM, McCloskey KA, Pearson-Shaver AL, Orr RA. Mortality and functional morbidity after use of PALS/APLS by community physicians. Pediatrics. 2009 Aug;124(2):500-8. doi: 10.1542/peds.2008-1967. Epub 2009 Jul 27. — View Citation

Critical care medicine. JAMA. 1983 Aug 12;250(6):798-804. — View Citation

Fiser DH. Outcome evaluations as measures of quality in pediatric intensive care. Pediatr Clin North Am. 1994 Dec;41(6):1423-38. Review. — View Citation

Frankel LR, Hsu BS, Yeh TS, Simone S, Agus MSD, Arca MJ, Coss-Bu JA, Fallat ME, Foland J, Gadepalli S, Gayle MO, Harmon LA, Hill V, Joseph CA, Kessel AD, Kissoon N, Moss M, Mysore MR, Papo ME, Rajzer-Wakeham KL, Rice TB, Rosenberg DL, Wakeham MK, Conway EE Jr; Voting Panel. Criteria for Critical Care Infants and Children: PICU Admission, Discharge, and Triage Practice Statement and Levels of Care Guidance. Pediatr Crit Care Med. 2019 Sep;20(9):847-887. doi: 10.1097/PCC.0000000000001963. — View Citation

Kollef MH, Schuster DP. Predicting intensive care unit outcome with scoring systems. Underlying concepts and principles. Crit Care Clin. 1994 Jan;10(1):1-18. Review. — View Citation

Lalitha AV, Fassl B, Gist RE, Shah BR, Chawla N, Singh A, Baranawal A, Shamarao S, Vanaki R, Mahajan P, Patel R, Chauhan V, Batra P, Saha A, Galwankar S, Soans S. 2019 WACEM - Academic College of Emergency Experts Consensus Recommendations on Admission Criteria to Pediatric Intensive Care Unit from the Emergency Departments in India. J Emerg Trauma Shock. 2019 Apr-Jun;12(2):155-162. doi: 10.4103/JETS.JETS_140_18. — View Citation

Levin DL, Downes JJ, Todres ID. History of pediatric critical care medicine. J Pediatr Intensive Care. 2013 Dec;2(4):147-167. doi: 10.3233/PIC-13068. Review. — View Citation

Nates JL, Nunnally M, Kleinpell R, Blosser S, Goldner J, Birriel B, Fowler CS, Byrum D, Miles WS, Bailey H, Sprung CL. ICU Admission, Discharge, and Triage Guidelines: A Framework to Enhance Clinical Operations, Development of Institutional Policies, and Further Research. Crit Care Med. 2016 Aug;44(8):1553-602. doi: 10.1097/CCM.0000000000001856. — View Citation

Smith G, Nielsen M. ABC of intensive care. Criteria for admission. BMJ. 1999 Jun 5;318(7197):1544-7. Review. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary outcome of Cardiac patients admitted to PICU To describe the indication of admission and treatment given such as use of inotropes such as epinephrine norepinephrine and mechanical ventilation , high flow nasal canula ..etc and outcome of each case measured by using vital signs (heart rate , Respiratory rate , temperature and blood pressure ) conscious level , signs of heart failure and finally number of deaths Baseline
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