NCT03308513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
888

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 7, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2017

Completed
20 days until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

3 months

First QC Date

October 7, 2017

Last Update Submit

September 13, 2020

Conditions

Keywords

Prolonged acute mechanical ventilation

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Critical care unit costs for infant patients

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

  • Critical care unit costs for premature newborn

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

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yuzuncu Yil University, School of Medicine

Van, Tusba / Zeve Kampus, 65080, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hilmi Demirkiran, Asist.prof.

    Department of Anethesiology and Reanimation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 7, 2017

First Posted

October 12, 2017

Study Start

November 1, 2017

Primary Completion

January 15, 2018

Study Completion

October 31, 2018

Last Updated

September 16, 2020

Record last verified: 2020-09

Locations