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

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ClinicalTrials.gov Identifier: NCT03308513
Recruitment Status : Unknown
Verified October 2017 by Hilmi Demirkiran, MD, Yuzuncu Yıl University.
Recruitment status was:  Recruiting
First Posted : October 12, 2017
Last Update Posted : January 9, 2018
Sponsor:
Collaborators:
Kahramanmaras Sutcu Imam University
Izmir Ataturk Training and Research Hospital
Information provided by (Responsible Party):
Hilmi Demirkiran, MD, Yuzuncu Yıl University

Tracking Information
First Submitted Date October 7, 2017
First Posted Date October 12, 2017
Last Update Posted Date January 9, 2018
Actual Study Start Date November 1, 2017
Estimated Primary Completion Date January 15, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2017)
Critical care unit mortality [ Time Frame: 30 Day, 90 Day, 180 Day, 365 day ]
The mortality change rates in the 30th Day, 90th Day, 180th Day, 365th Day
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 11, 2017)
  • Critical care unit costs for infant patients [ Time Frame: Duration of intensive care unit stay (From 14 day to 1 years after hospitalization) ]
    Cost of patients staying in intensive care unit
  • Critical care unit costs for premature newborn [ Time Frame: Duration of intensive care unit stay (From 1 month to 1 year after hospitalization) ]
    Cost of patients staying in intensive care unit
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients who are younger than 18 years or are in intensive care unit
Condition Critical Illness
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 11, 2017)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 31, 2018
Estimated Primary Completion Date January 15, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages up to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT03308513
Other Study ID Numbers Pediatric critical illness
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Hilmi Demirkiran, MD, Yuzuncu Yıl University
Study 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
PRS Account Yuzuncu Yıl University
Verification Date October 2017