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CompletedNCT03308513Updated Sep 16, 2020

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

An observational study in Critical Illness, sponsored by Yuzuncu Yıl University. Completed at 1 site in Turkey. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2020-09-16.

Sponsored by Yuzuncu Yıl University · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
888
Ages
Up to 18 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Critical Illness

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Keywords

  • Prolonged acute mechanical ventilation
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In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's enrollment of 888 is above the median of 140 across 814 observational studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Yuzuncu Yıl University is the lead sponsor of 124 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Retrospective
Enrollment
888 participants (actual)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Critical care unit mortality

    The mortality change rates in the 30th Day, 90th Day, 180th Day, 365th Day

    Time frame: 30 Day, 90 Day, 180 Day, 365 day

Secondary outcomes

  1. Critical care unit costs for infant patients

    Cost of patients staying in intensive care unit

    Time frame: Duration of intensive care unit stay (From 14 day to 1 years after hospitalization)

  2. Critical care unit costs for premature newborn

    Cost of patients staying in intensive care unit

    Time frame: Duration of intensive care unit stay (From 1 month to 1 year after hospitalization)

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Study locations

1 site
  • Yuzuncu Yil University, School of Medicine
    Van, Tusba / Zeve Kampus 65080, Turkey
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References and documents

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. PubMed 34048449 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in Jan 2018, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 7, 2017
First posted
Oct 12, 2017
StartActual
Nov 1, 2017
Primary completionActual
Jan 15, 2018
CompletionActual
Oct 31, 2018
Last update
Sep 16, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03308513
Collaborators
Kahramanmaras Sutcu Imam University, Izmir Ataturk Training and Research Hospital
Responsible party
Hilmi Demirkiran, MD (Assistant Professor, Yuzuncu Yıl University) — Principal investigator
First posted
Oct 12, 2017
Start date
Nov 1, 2017
Primary completion
Jan 15, 2018
Completion
Oct 31, 2018
Last update
Sep 16, 2020

Study contacts

Hilmi Demirkiran, Asist.prof.
principal investigator · Department of Anethesiology and Reanimation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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