Determination of Risk Factors and Mortality for Pediatric Chronic Critical Illness in Turkey

Determination of Risk Factors and Mortality for Pediatric Chronic Critical Illnes in Turkey: Multicenter Study

It is predicted that the number of Pediatric Chronic Critical Illness increases similar to adult all over the world. The prevalence of Pediatric Chronic Critical Illness in Turkey is unknown. The investigators aimed to evaluate the etiology, comorbid conditions, demographic data, prevalence, mortality and costs of these patient in intensive care units in Turkey. In this multi-centered study, The investigators will retrospectively review the last 3 year of patients receiving treatment at the Intensive Care Unit.

Study Overview

• Status: Completed
• Conditions: Critical Illness

Detailed Description

Patients receiving acute critical cause of ICU in the Intensive Care Unit (ICU) may be hospitalized for longer periods of time due to accompanying diseases or iatrogenic causes. This disease is called "Chronic Critical Illness" (CCI). CCI is associated with prolonged acute mechanical ventilation, but there is no definition in the literature for newborns. Pediatric CCI is estimated to be similar to adults. In the United States, the number of CCI is around 250,000, which is estimated to have doubled in the last 10 years. 50% of patients die in one year and much less than 12% recover. The estimated annual cost for the CCI in the United States is over $ 20 billion. The prevalence of Pediatric CCI in Turkey is unknown. In this study, it was aimed to investigate risk factors, mortality and cost of children with chronic critically ill and newborn patients in intensive care units in Turkey.

• Study Type: Observational
• Enrollment (Actual): 888

Contacts and Locations

Study Locations

• Turkey
  • Tusba / Zeve Kampus
    • Van, Tusba / Zeve Kampus, Turkey, 65080
      • Yuzuncu Yil University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are younger than 18 years or are in intensive care unit

Description

Inclusion Criteria:

• Chronic Critical IIlness
• The patients who are younger than 18 years old and staying in ICU for at least 14 days.

(The patients who is newborn and stay in the intensive care unit for 30 days in addition to prematurity).

At least one of the additional criteria;

• Prolonged acute mechanical ventilation
• Tracheostomy
• Sepsis
• Severe wound (burn) or trauma
• Encephalopathy (Post resuscitation syndrome, Asphyxia, Intra-cranial hemorrhage, Metabolic disease, etc.)
• Traumatic brain injury
• Status epilepticus
• Post operative (Cardiac and noncardiac)
• Neuromuscular disease (Spinal Muscular Dystrophy, Cerebral Palsy, Muscular Dystrophy)

Exclusion Criteria:

• Patients with a disease other than a chronic critical disease
• Patients older than 18 years

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Critical care unit mortality	The mortality change rates in the 30th Day, 90th Day, 180th Day, 365th Day	30 Day, 90 Day, 180 Day, 365 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Critical care unit costs for infant patients	Cost of patients staying in intensive care unit	Duration of intensive care unit stay (From 14 day to 1 years after hospitalization)
Critical care unit costs for premature newborn	Cost of patients staying in intensive care unit	Duration of intensive care unit stay (From 1 month to 1 year after hospitalization)

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University
• Collaborators: Kahramanmaras Sutcu Imam University; Izmir Ataturk Training and Research Hospital
• Investigators: Principal Investigator: Hilmi Demirkiran, Asist.prof., Department of Anethesiology and Reanimation

Publications and helpful links

General Publications

• Demirkiran H, Kilic M, Tomak Y, Dalkiran T, Yurttutan S, Basaranoglu M, Tuncer O, Derme T, Tekeli AE, Bahar I, Keskin S, Oksuz H. Evaluation of the incidence, characteristics, and outcomes of pediatric chronic critical illness. PLoS One. 2021 May 28;16(5):e0248883. doi: 10.1371/journal.pone.0248883. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2017
• Primary Completion (Actual): January 15, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: October 7, 2017
• First Submitted That Met QC Criteria: October 11, 2017
• First Posted (Actual): October 12, 2017

Study Record Updates

• Last Update Posted (Actual): September 16, 2020
• Last Update Submitted That Met QC Criteria: September 13, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Prolonged acute mechanical ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: Pediatric critical illness

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