Indication of Admission , Treatment and Outcomes of Cardiac Patients in PICU

Patterns and Outcome of Cardiac Patients Admitted to PICU

Aim of the work:

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

Study Overview

• Status: Not yet recruiting
• Conditions: Cardiac Disease
• Intervention / Treatment: Other: Evidence based management

Detailed 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

• Study Type: Observational
• Enrollment (Anticipated): 72

Contacts and Locations

• Study Contact: Name: Mina refaet, resident; Phone Number: 01224485728 01013491003; Email: mena.20134402@med.aun.edu.eg
• Study Contact Backup: Name: Ghada Omar Mahmoud Elsedfy, Prof; Phone Number: 01111985154; Email: Ghada.mahmoud1@med.au.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric cardiac patients aged 1 minth to 18 years old admitted to PICU

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cardiac patients admitted to PICU; To describe the clinical patterns of infants and children with cardiac disease admitted to PICU and their outcome.	Other: Evidence based management; clinical patterns , laboratory investigations , radiology , lines of managements and outcome of each modality of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Study Director: Ismail Lotfy Mohamad Ibrahim, Ass. prof, Pediatrics

Publications and helpful links

General Publications

• Smith G, Nielsen M. ABC of intensive care. Criteria for admission. BMJ. 1999 Jun 5;318(7197):1544-7. doi: 10.1136/bmj.318.7197.1544. No abstract available.
• 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. doi: 10.1378/chest.104.6.1806.
• Critical care medicine. JAMA. 1983 Aug 12;250(6):798-804. No abstract available.
• 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.
• 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.
• 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.
• 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.
• Fiser DH. Outcome evaluations as measures of quality in pediatric intensive care. Pediatr Clin North Am. 1994 Dec;41(6):1423-38. doi: 10.1016/s0031-3955(16)38880-0.
• 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. doi: 10.1097/00003246-199808000-00031.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: June 17, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): July 5, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: cardiac patient in PICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No