Determination of Risk Factors and Mortality for Pediatric... | NCT03308513

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

NCT03308513

Sponsor

Yuzuncu Yil University

Status

Completed

Last Update Posted

Sep 16, 2020Actual

Enrollment

888Actual

Phase

Not provided

Conditions

Critical Illness

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2017Actual

Primary Completion Date

Jan 15, 2018Actual

Completion Date

Oct 31, 2018Actual

First Submitted Date

Oct 7, 2017

First Submission Date that Met QC Criteria

Oct 11, 2017

First Posted Date

Oct 12, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 13, 2020

Last Update Posted Date

Sep 16, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hilmi Demirkiran, MD, Assistant Professor, Yuzuncu Yil UniversityPrincipal Investigator

Lead Sponsor

Yuzuncu Yil UniversityOTHER

Collaborators

Name	Class
Kahramanmaras Sutcu Imam University	OTHER
Izmir Ataturk Training and Research Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

888Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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)
Critical care unit costs for premature newborn

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hilmi Demirkiran, Asist.prof.	Department of Anethesiology and Reanimation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yuzuncu Yil University, School of Medicine		Van	Tusba / Zeve Kampus	65080	Turkey (Türkiye)

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34048449	Derived	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.

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms