Critical IllnessINAPPT-ICUNCT03520270
Prevalence of Potentially Inappropriate Treatments
An observational study of Critical Illness and Terminal Illness, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
A multicenter point prevalence study in Turkish intensive care units. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Terminal Illness, Potentially Inappropriate Medication List
- How many people
- 1,128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2018to 30 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All intensive care patients fulfilling eligibility criteria
Who may be able to join
- All patients who are over 18 years old, more than 48 hours in the intensive care unit, or expected to be hospitalized
Who cannot join
- Patients under 18 years of age, less than 48 hours in the intensive care unit stay, or who are monitorized for post-operative care
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa Medical School
Istanbul
About this study
Official title: Potentially Inappropriate Treatments in Turkish ICUs: Point Prevalence Study
A multicenter point prevalence study in Turkish intensive care units.
Read the detailed description
Intensive care units (ICU) are life-saving units for critical patients with using advanced technology. In some cases, it becomes a unit where treatment is not possible, the fatal patients are admitted and the death process is extended. Most patients with end-stage cancer, advanced-stage chronic obstructive pulmonary disease (COPD) and advanced-stage Alzheimer's disease prefer to die at home, although many often refer to emergency services at the end of their life and are then transferred to the ICU. Intensive care treatments are often very invasive and painful interventions. The patient who lives in intensive care unit is faced with many psychological distresses such as communication, isolation and fear besides physical ache. For this reason, it is necessary to make decisions (end-of-life decisions) such as forbearing intensive care treatments applied to the patients in the death process or cutting out the ones started. In the world, the goal for the end of life patients is, improving the last phase of their lives with the application of these decisions and symptom therapy, living in a peace without pain and respiratory distress. However, there is an uncertanity in these issues in our country and intensive care physicians are hesitant to make decisions about the end of life with concern about legal problems. Although it is known that these patients will not benefit most from the treatment of ICU, they are getting treatments for saving their lives in ICUs. The fact that intensive care beds are not available due to the patients who are not get beneficial treatment, brings the result of difficult finding of the beds which will benefit from the intensive care, and in fact it is a waste of intensive care resources which is very expensive. The size of the problem is not known as there is no data on the frequency of patients in our country who are in intensive care and require end-of-life care.
In this multicenter point prevalence study our aims are;
- to find out the incidence of patients in intensive care units in Turkey in the last period of life,
- to compare the resource use of end-of-life and non-end-of-life patients.
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of terminal patients in the ICU
Investigation of the number of terminal patients treated in the intensive care units at the last days of life
Measured: 1 day
Secondary outcomes (1)
Resource use
Comparison of treatment implementations such as antibiotics, use of mechanical ventilation, renal replacement therapy, nutrition and blood transfusions and their estimated costs, used for terminal and non-terminal patients
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start15 Oct 2018
- Primary completion14 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 1,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ELIF ERDOGAN, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520270
- Sponsor's protocol ID
- EERDOGAN
- Acronym
- INAPPT-ICU
- Status last verified
- Feb 2019
- First submitted
- 13 Apr 2018
- Last updated
- 1 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nelson JE, Bassett R, Boss RD, Brasel KJ, Campbell ML, Cortez TB, Curtis JR, Lustbader DR, Mulkerin C, Puntillo KA, Ray DE, Weissman DE; Improve Palliative Care in the Intensive Care Unit Project. Models for structuring a clinical initiative to enhance palliative care in the intensive care unit: a report from the IPAL-ICU Project (Improving Palliative Care in the ICU). Crit Care Med. 2010 Sep;38(9):1765-72. doi: 10.1097/CCM.0b013e3181e8ad23.
PubMed 20562699Shreves A, Marcolini E. End of life/palliative care/ethics. Emerg Med Clin North Am. 2014 Nov;32(4):955-74. doi: 10.1016/j.emc.2014.07.010. Epub 2014 Sep 16.
PubMed 25441045
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potentially Inappropriate Treatments in Turkish ICUs: Point Prevalence Study
- ClinicalTrials.gov ID
- NCT03520270
- Acronym / sponsor ID
- INAPPT-ICU / EERDOGAN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,128 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 9 May 2018 (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.
A multicenter point prevalence study in Turkish intensive care units.
Detailed description
Intensive care units (ICU) are life-saving units for critical patients with using advanced technology. In some cases, it becomes a unit where treatment is not possible, the fatal patients are admitted and the death process is extended. Most patients with end-stage cancer, advanced-stage chronic obstructive pulmonary disease (COPD) and advanced-stage Alzheimer's disease prefer to die at home, although many often refer to emergency services at the end of their life and are then transferred to the ICU. Intensive care treatments are often very invasive and painful interventions. The patient who lives in intensive care unit is faced with many psychological distresses such as communication, isolation and fear besides physical ache. For this reason, it is necessary to make decisions (end-of-life decisions) such as forbearing intensive care treatments applied to the patients in the death process or cutting out the ones started. In the world, the goal for the end of life patients is, improving the last phase of their lives with the application of these decisions and symptom therapy, living in a peace without pain and respiratory distress. However, there is an uncertanity in these issues in our country and intensive care physicians are hesitant to make decisions about the end of life with concern about legal problems. Although it is known that these patients will not benefit most from the treatment of ICU, they are getting treatments for saving their lives in ICUs. The fact that intensive care beds are not available due to the patients who are not get beneficial treatment, brings the result of difficult finding of the beds which will benefit from the intensive care, and in fact it is a waste of intensive care resources which is very expensive. The size of the problem is not known as there is no data on the frequency of patients in our country who are in intensive care and require end-of-life care.
In this multicenter point prevalence study our aims are;
- to find out the incidence of patients in intensive care units in Turkey in the last period of life,
- to compare the resource use of end-of-life and non-end-of-life patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All intensive care patients fulfilling eligibility criteria
Key inclusion criteria (1 listed)
- All patients who are over 18 years old, more than 48 hours in the intensive care unit, or expected to be hospitalized
Key exclusion criteria (1 listed)
- Patients under 18 years of age, less than 48 hours in the intensive care unit stay, or who are monitorized for post-operative care
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
Prevalence of terminal patients in the ICU
Time frame: 1 day
Investigation of the number of terminal patients treated in the intensive care units at the last days of life
1 secondary outcome
Resource use
Time frame: 1 day
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 1 Mar 2019.
- Results publication: PubMed 20562699Nelson JE, Bassett R, Boss RD, Brasel KJ, Campbell ML, Cortez TB, Curtis JR, Lustbader DR, Mulkerin C, Puntillo KA, Ray DE, Weissman DE; Improve Palliative Care in the Intensive Care Unit Project. Models for structuring a clinical initiative to enhance palliative care in the intensive care unit: a report from the IPAL-ICU Project (Improving Palliative Care in the ICU). Crit Care Med. 2010 Sep;38(9):1765-72. doi: 10.1097/CCM.0b013e3181e8ad23.
- Results publication: PubMed 25441045Shreves A, Marcolini E. End of life/palliative care/ethics. Emerg Med Clin North Am. 2014 Nov;32(4):955-74. doi: 10.1016/j.emc.2014.07.010. Epub 2014 Sep 16.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Terminal Illness, run by Istanbul 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 1 inclusion and 1 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 1 Mar 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?
Prevalence of terminal patients in the ICU (time frame: 1 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 NCT03520270, which also lists 2 linked publications.
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 1 Mar 2019.