NCT05442385

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2022

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

1 year

First QC Date

June 17, 2022

Last Update Submit

June 29, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

clinical patterns , laboratory investigations , radiology , lines of managements and outcome of each modality of treatment

cardiac patients admitted to PICU

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • pediatric patient without cardiac diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • 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.

    PMID: 8252969BACKGROUND
  • Critical care medicine. JAMA. 1983 Aug 12;250(6):798-804. No abstract available.

    PMID: 6348315BACKGROUND
  • 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.

    PMID: 8118722BACKGROUND
  • 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.

    PMID: 27428118BACKGROUND
  • 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.

    PMID: 10356016BACKGROUND
  • 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.

    PMID: 19651576BACKGROUND
  • 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.

    PMID: 31214438BACKGROUND
  • 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.

    PMID: 7984393BACKGROUND
  • 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.

    PMID: 9710104BACKGROUND
  • 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.

    PMID: 31198285BACKGROUND
  • 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.

    PMID: 31483379BACKGROUND

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Ismail Lotfy Mohamad Ibrahim, Ass. prof

    Pediatrics

    STUDY DIRECTOR

Central Study Contacts

Mina refaet, resident

CONTACT

Ghada Omar Mahmoud Elsedfy, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

June 17, 2022

First Posted

July 5, 2022

Study Start

August 1, 2022

Primary Completion

August 1, 2023

Study Completion

September 1, 2023

Last Updated

July 5, 2022

Record last verified: 2022-06