Critical IllnessNCT03308513
Determination of Risk Factors and Mortality for Pediatric Chronic Critical Illness in Turkey
An observational study of Critical Illness, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Critical Illness
- How many people
- 888 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2017to 31 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who are younger than 18 years or are in intensive care unit
Who may be able to join
- 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
Show all 13Show fewer
- 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)
Who cannot join
- Patients with a disease other than a chronic critical disease
- Patients older than 18 years
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuzuncu Yil University, School of Medicine
Van, Tusba / Zeve Kampus, 65080
About this study
Official title: Determination of Risk Factors and Mortality for Pediatric Chronic Critical Illnes in Turkey: Multicenter Study
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.
Read the 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.
- Conditions
- Critical Illness
- Keywords
- Prolonged acute mechanical ventilation
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical care unit mortality
The mortality change rates in the 30th Day, 90th Day, 180th Day, 365th Day
Measured: 30 Day, 90 Day, 180 Day, 365 day
Secondary outcomes (2)
Critical care unit costs for infant patients
Cost of patients staying in intensive care unit
Measured: Duration of intensive care unit stay (From 14 day to 1 years after hospitalization)
Critical care unit costs for premature newborn
Cost of patients staying in intensive care unit
Measured: Duration of intensive care unit stay (From 1 month to 1 year after hospitalization)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2017
- Study start1 Nov 2017
- Primary completion15 Jan 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 888 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University, Izmir Ataturk Training and Research Hospital
- Responsible party
- Principal investigator, Hilmi Demirkiran, MD, Yuzuncu Yil University
- Investigators
- Hilmi Demirkiran, Asist.prof., Principal investigator, Department of Anethesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03308513
- Sponsor's protocol ID
- Pediatric critical illness
- Status last verified
- Sep 2020
- First submitted
- 7 Oct 2017
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34048449
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Risk Factors and Mortality for Pediatric Chronic Critical Illnes in Turkey: Multicenter Study
- ClinicalTrials.gov ID
- NCT03308513
- Acronym / sponsor ID
- Pediatric critical illness
- Conditions
- Critical Illness
- Keywords
- Prolonged acute mechanical ventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 888 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University, Izmir Ataturk Training and Research Hospital
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 12 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who are younger than 18 years or are in intensive care unit
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with a disease other than a chronic critical disease
- Patients older than 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Critical care unit costs for infant patients
Time frame: Duration of intensive care unit stay (From 14 day to 1 years after hospitalization)
Critical care unit costs for premature newborn
Time frame: Duration of intensive care unit stay (From 1 month to 1 year after hospitalization)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Derived from this study: PubMed 34048449Demirkiran 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hilmi Demirkiran, Asist.prof. principal investigator
Department of Anethesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Critical care unit mortality (time frame: 30 Day, 90 Day, 180 Day, 365 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03308513, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2020.