Cardiac DiseaseNCT05442385
Indication of Admission , Treatment and Outcomes of Cardiac Patients in PICU
An observational study of Cardiac Disease, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Evidence based management
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Sep 2023
- 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 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric cardiac patients aged 1 minth to 18 years old admitted to PICU
Who may be able to join
- Infants and children aged 1 month to 18 years.
- 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
Who cannot join
- pediatric patient without cardiac diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
- Conditions
- Cardiac Disease
- Being tested
- Evidence based management
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evidence based managementOther
clinical patterns , laboratory investigations , radiology , lines of managements and outcome of each modality of treatment
| Study group | Role | What they receive |
|---|---|---|
| cardiac patients admitted to PICU | To describe the clinical patterns of infants and children with cardiac disease admitted to PICU and their outcome. Receives: Other: Evidence based management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Aug 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cardiac DiseaseStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Refaet Zakher, Assiut University
- Investigators
- Ismail Lotfy Mohamad Ibrahim, Ass. prof, Study director, Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442385
- Sponsor's protocol ID
- cardiac patient in PICU
- Status last verified
- Jun 2022
- First submitted
- 17 Jun 2022
- Last updated
- 5 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 8252969Critical care medicine. JAMA. 1983 Aug 12;250(6):798-804. No abstract available.
PubMed 6348315Kollef MH, Schuster DP. Predicting intensive care unit outcome with scoring systems. Underlying concepts and principles. Crit Care Clin. 1994 Jan;10(1):1-18.
PubMed 8118722Nates 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.
PubMed 27428118Smith 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.
PubMed 10356016Carcillo 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.
PubMed 19651576Levin 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.
PubMed 31214438Fiser 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.
PubMed 7984393Bertolini 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.
PubMed 9710104Lalitha 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.
PubMed 31198285Frankel 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.
PubMed 31483379
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns and Outcome of Cardiac Patients Admitted to PICU
- ClinicalTrials.gov ID
- NCT05442385
- Acronym / sponsor ID
- cardiac patient in PICU
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 5 Jul 2022 (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.
Aim of the work:
To describe the clinical patterns criteria of infants and children with cardiac disease admitted to PICU and their outcome.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac patients admitted to PICU | – | Other: Evidence based managementTo describe the clinical patterns of infants and children with cardiac disease admitted to PICU and their outcome. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric cardiac patients aged 1 minth to 18 years old admitted to PICU
Key inclusion criteria (2 listed)
- Infants and children aged 1 month to 18 years.
- 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
Key exclusion criteria (1 listed)
- pediatric patient without cardiac diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evidence based managementclinical patterns , laboratory investigations , radiology , lines of managements and outcome of each modality of treatment | Other | cardiac patients admitted to PICU |
Primary outcome
outcome of Cardiac patients admitted to PICU
Time frame: Baseline
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2022.
- Background: PubMed 8252969Bone 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.
- Background: PubMed 6348315Critical care medicine. JAMA. 1983 Aug 12;250(6):798-804. No abstract available.
- Background: PubMed 8118722Kollef MH, Schuster DP. Predicting intensive care unit outcome with scoring systems. Underlying concepts and principles. Crit Care Clin. 1994 Jan;10(1):1-18.
- Background: PubMed 27428118Nates 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.
- Background: PubMed 10356016Smith 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.
- Background: PubMed 19651576Carcillo 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.
- Background: PubMed 31214438Levin 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.
- Background: PubMed 7984393Fiser 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.
- Background: PubMed 9710104Bertolini 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.
- Background: PubMed 31198285Lalitha 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.
- Background: PubMed 31483379Frankel 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.
- Individual participant dataSharing planned: Undecided
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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.
Ismail Lotfy Mohamad Ibrahim, Ass. prof study director
Pediatrics
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Disease, 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 2 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 5 Jul 2022. 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 Mina refaet, resident (01013491003 ext. 01224485728, mena.20134402@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
outcome of Cardiac patients admitted to PICU (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 NCT05442385, which also lists 11 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 5 Jul 2022.