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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 : 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

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.

Condition or disease
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
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Determination of Risk Factors and Mortality for Pediatric Chronic Critical Illnes in Turkey: Multicenter Study
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : January 15, 2018
Estimated Study Completion Date : October 31, 2018



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients who are younger than 18 years or are in intensive care unit
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03308513


Contacts
Contact: Hilmi Demirkiran, Assist.prof. +905336676188 h.dkiran@hotmail.com
Contact: Hafize Oksuz, Prof.doctor +905323283187 drhoksuz@hotmail.com

Locations
Turkey
Yuzuncu Yil University, School of Medicine Recruiting
Van, Tusba / Zeve Kampus, Turkey, 65080
Contact: Hilmi Demirkiran, MD    +905336676188    h.dkiran@hotmail.com   
Contact: Aydin Cagac, MD    +905065991141    aydincagac@hotmail.com   
Sponsors and Collaborators
Yuzuncu Yıl University
Kahramanmaras Sutcu Imam University
Izmir Ataturk Training and Research Hospital
Investigators
Principal Investigator: Hilmi Demirkiran, Asist.prof. Department of Anethesiology and Reanimation

Responsible Party: Hilmi Demirkiran, MD, Assistant Professor, Yuzuncu Yıl University
ClinicalTrials.gov Identifier: NCT03308513     History of Changes
Other Study ID Numbers: Pediatric critical illness
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hilmi Demirkiran, MD, Yuzuncu Yıl University:
Prolonged acute mechanical ventilation

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes