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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03308513
• Other study ID #: Pediatric critical illness
• Status: Completed
• Start date: November 1, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: September 2020
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 888
• Est. completion date: October 31, 2018
• Est. primary completion date: January 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Turkey	Yuzuncu Yil University, School of Medicine	Van	Tusba / Zeve Kampus

Sponsors (3)

Lead Sponsor	Collaborator
Yuzuncu Yil University	Izmir Ataturk Training and Research Hospital, Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)