Clinical trial NCT03308513: Determination of Risk Factors and Mortality for Pediatric Chronic Critical Illness in Turkey
Official title: Determination of Risk Factors and Mortality for Pediatric Chronic Critical Illnes in Turkey: Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Illness
Keywords: Prolonged acute mechanical ventilation
Lead sponsor: Yuzuncu Yıl University
Sponsor class: OTHER
Collaborators: name: Kahramanmaras Sutcu Imam University
name: Izmir Ataturk Training and Research Hospital
First posted: 2017-10-12
Enrollment: 888
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are younger than 18 years or are in intensive care unit

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Critical care unit mortality
timeFrame: 30 Day, 90 Day, 180 Day, 365 day
Secondary outcomes:
measure: Critical care unit costs for infant patients
timeFrame: Duration of intensive care unit stay (From 14 day to 1 years after hospitalization)
measure: Critical care unit costs for premature newborn
timeFrame: Duration of intensive care unit stay (From 1 month to 1 year after hospitalization)
Other outcomes:
Locations:
city: Van
country: Turkey
facility: Yuzuncu Yil University, School of Medicine
state: Tusba / Zeve Kampus
Study officials:
affiliation: Department of Anethesiology and Reanimation
name: Hilmi Demirkiran, Asist.prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.