Chronic Critical IllnessNCT03262883
The Prevalence of Chronic Critical Illness in Turkey
An observational study of Chronic Critical Illness, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
It is known that the number of Chronic Critical İllnes, an iatrogenic condition, increases all over the world. The prevalence of 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Critical Illness
- How many people
- 2,493 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2017to 28 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patient older than 18 years old staying in the intensive care unit longer than 8 days
Who may be able to join
- The patient who is over 18 years old, taking mechanical ventilation support and staying in the critical care unit at least 8 days. Additional criterias; Clinical diagnosis of following situations:
- Prolonged mechanical ventilation
- Tracheotomia
- Sepsis
- Serious injury (burn)
- Stroke ( hemorhagic or ischemic)
- Traumatic brain injury
Who cannot join
- The patients who not having mechanical ventilation support
- The patient staying less than 8 days in the intensive care unit
- The patient younger than 18 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prevalence of Chronic Critical Illness Adult Intensive Care Units in Turkey
It is known that the number of Chronic Critical İllnes, an iatrogenic condition, increases all over the world. The prevalence of 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 1 year of patients receiving treatment at the Adult Intensive Care Unit.
Read the detailed description
The patients who survive an acute critical illness in the Intensive Care Unit (ICU) may be delayed in a situation where they are sometimes totally independent before hand due to iatrogenic causes such as infections, dysfunctions, psychological disorders. This can take weeks, sometimes months. This disease is called "Chronic Critical Illness" (CCI).
Most researchers associate CCI with the need for prolonged acute mechanical ventilation or the opening of tracheostomy for prolonged acute mechanical ventilation. There is no single condition that does not require an extended mechanical ventilation from CCI. In conclusion, CCI is characterized by long-term care requiring survival and it is predicted that the cost of these patients will increase with the new patients whose cost will be added in the coming years. In the United States, the number of CCI is around 250,000, and this figure has increased by 50-100% in the last 10 years. At least 50% of these patients die in one year and less than 12% recover and become discharged. The annual cost of these patients' health care system is over $ 20 billion. The prevalence of CCI in Turkey is still unknown. In this study, it was aimed to investigate the prevalence of patients with Chronic Critical Syndrome in intensive care units in Turkey.
- Conditions
- Chronic Critical Illness
- Keywords
- Prolonged akut mechanical ventilation, Tracheotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Critical Illness | The patients who is over 18 years old and staying in the critical care unit at least 8 days. Additional criterias: 1. Prolonged mechanical ventilation (longer than 96 hours) 2. Tracheostomy 3. Sepsis 4. Serious injury (burn) 5. Stroke (hemorhagic or ischemic) 6. Traumatic brain injury |
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 days and 90th days
Measured: 30 day and 90 day
Secondary outcomes (1)
Critical care unit costs
Costs of patients staying in the intensive care unit
Measured: Duration of intensive care unit stay (8 day after the hospitalisation to sixth month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Sep 2017
- Primary completion1 Dec 2018
- Study completion28 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- 2,493 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 Demirkıran, Principal investigator, Official of the university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03262883
- Sponsor's protocol ID
- Chronic critical illness
- Status last verified
- Oct 2019
- First submitted
- 18 Aug 2017
- Last updated
- 10 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Chronic Critical Illness Adult Intensive Care Units in Turkey
- ClinicalTrials.gov ID
- NCT03262883
- Acronym / sponsor ID
- Chronic critical illness
- Conditions
- Chronic Critical Illness
- Keywords
- Prolonged akut mechanical ventilation, Tracheotomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,493 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Collaborators
- Kahramanmaras Sutcu Imam University, Izmir Ataturk Training and Research Hospital
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 28 Apr 2019 (actual)
- First posted
- 25 Aug 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 known that the number of Chronic Critical İllnes, an iatrogenic condition, increases all over the world. The prevalence of 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 1 year of patients receiving treatment at the Adult Intensive Care Unit.
Detailed description
The patients who survive an acute critical illness in the Intensive Care Unit (ICU) may be delayed in a situation where they are sometimes totally independent before hand due to iatrogenic causes such as infections, dysfunctions, psychological disorders. This can take weeks, sometimes months. This disease is called "Chronic Critical Illness" (CCI).
Most researchers associate CCI with the need for prolonged acute mechanical ventilation or the opening of tracheostomy for prolonged acute mechanical ventilation. There is no single condition that does not require an extended mechanical ventilation from CCI. In conclusion, CCI is characterized by long-term care requiring survival and it is predicted that the cost of these patients will increase with the new patients whose cost will be added in the coming years. In the United States, the number of CCI is around 250,000, and this figure has increased by 50-100% in the last 10 years. At least 50% of these patients die in one year and less than 12% recover and become discharged. The annual cost of these patients' health care system is over $ 20 billion. The prevalence of CCI in Turkey is still unknown. In this study, it was aimed to investigate the prevalence of patients with Chronic Critical Syndrome in intensive care units in Turkey.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Critical Illness | – | –The patients who is over 18 years old and staying in the critical care unit at least 8 days. Additional criterias: 1. Prolonged mechanical ventilation (longer than 96 hours) 2. Tracheostomy 3. Sepsis 4. Serious injury (burn) 5. Stroke (hemorhagic or ischemic) 6. Traumatic brain injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient older than 18 years old staying in the intensive care unit longer than 8 days
Key inclusion criteria (7 listed)
- The patient who is over 18 years old, taking mechanical ventilation support and staying in the critical care unit at least 8 days. Additional criterias; Clinical diagnosis of following situations:
- Prolonged mechanical ventilation
- Tracheotomia
- Sepsis
- Serious injury (burn)
Key exclusion criteria (3 listed)
- The patients who not having mechanical ventilation support
- The patient staying less than 8 days in the intensive care unit
- The patient younger than 18 years old
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 and 90 day
The mortality change rates in the 30th days and 90th days
1 secondary outcome
Critical care unit costs
Time frame: Duration of intensive care unit stay (8 day after the hospitalisation to sixth month)
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 10 Oct 2019.
- 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 Demirkıran principal investigator
Official of the university
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 Chronic 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 7 inclusion and 3 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 10 Oct 2019. 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 and 90 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2019.