Intensive Care PatientsNCT06770751
Family Involvement in ICU
An observational study of Intensive Care Patients and Relatives, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this prospective cohort study was to investigate the effect of the time spent with relatives of patients treated in a tertiary intensive care unit on patient outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Patients, Relatives, Delirium in the Intensive Care Unit
- How many people
- 122 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Jan 2025to 15 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: patients in a tertiary intensive care unit of a university hospital
Who may be able to join
- Patients aged 18 and over.
- Patients with at least one family member actively involved in the care process in the ICU.
Who cannot join
- Patients with pre-existing cognitive impairment or dementia.
- Patients with severe traumatic brain injury.
- Patients with an expected mortality in the ICU of more than 80%.
- Absence of family members for patients admitted to the ICU.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Cerrahpaşa Medical Faculty
Istanbul, 34153
Oguzhan Kayhan, 0090 212 414 3000 ext. 63943, oguzhan.kayhan@iuc.edu.tr
About this study
Official title: Family Involvement in the Intensive Care Unit: a Prospective Cohort Study Exploring Its Effects on Sedation Dosages, Delirium, Ventilator-Free Days, and Length of Stay.
The aim of this prospective cohort study was to investigate the effect of the time spent with relatives of patients treated in a tertiary intensive care unit on patient outcomes.
The main question it aimed to answer was:
Does spending more time with relatives of patients in intensive care result in lower sedative agent requirements? Does spending more time with relatives of patients in intensive care result in less delirium, fewer ventilator days, and shorter ICU stays?
- Conditions
- Intensive Care Patients, Relatives, Delirium in the Intensive Care Unit, Sedatives, Family
- Keywords
- Intensive care patients, relatives, Delirium in the intensive care unit, Sedatives
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 |
|---|---|---|
| Short involvement of family | A group where relatives spend up to 2 hours with patients and are involved in their care. | |
| Long involvement of family | A group where relatives spend more than 2 hours with patients and are involved in their care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sedative dose
It is the average daily dose of sedative drugs used by a patient. It will be calculated for each sedative drug. It will be calculated by dividing all doses taken by the number of days of hospitalization.
Measured: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.
Secondary outcomes (3)
Delirium
Each patient will be assessed for delirium every day during their hospitalization. CAM-ICU scoring will be used for assessment. The average number of delirium days for each patient will be found by dividing the number of days they were in delirium by the total number of days they were in hospital.
Measured: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.
Ventilatory days
For each patient, the number of days they are on a ventilator will be calculated as a percentage of their length of stay. For each patient, the days they receive invasive ventilation will be divided by the number of days they are treated in the intensive care unit to calculate the percentage.
Measured: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.
Stay in intensive care unit
The length of time each patient stays in intensive care will be recorded.
Measured: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start13 Jan 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care PatientsStudies 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
- Prospective
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguzhan Kayhan, Istanbul University - Cerrahpasa
- Investigators
- Oktay Demirkiran, Professor, Study director, İstanbul University - Cerrahpaşa, Cerrahpaşa Medical FacultyOguzhan Kayhan, Principal investigator, İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770751
- Sponsor's protocol ID
- 2024/231
- Status last verified
- Jan 2025
- First submitted
- 8 Jan 2025
- Last updated
- 17 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Ethics committee approval was not obtained for sharing patient data with an international database.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family Involvement in the Intensive Care Unit: a Prospective Cohort Study Exploring Its Effects on Sedation Dosages, Delirium, Ventilator-Free Days, and Length of Stay.
- ClinicalTrials.gov ID
- NCT06770751
- Acronym / sponsor ID
- 2024/231
- Conditions
- Intensive Care Patients, Relatives, Delirium in the Intensive Care Unit, Sedatives, Family
- Keywords
- Intensive care patients, relatives, Delirium in the intensive care unit, Sedatives
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 13 Jan 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 13 Jan 2025 (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.
The aim of this prospective cohort study was to investigate the effect of the time spent with relatives of patients treated in a tertiary intensive care unit on patient outcomes.
The main question it aimed to answer was:
Does spending more time with relatives of patients in intensive care result in lower sedative agent requirements? Does spending more time with relatives of patients in intensive care result in less delirium, fewer ventilator days, and shorter ICU stays?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short involvement of family | – | –A group where relatives spend up to 2 hours with patients and are involved in their care. |
| Long involvement of family | – | –A group where relatives spend more than 2 hours with patients and are involved in their care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients in a tertiary intensive care unit of a university hospital
Key inclusion criteria (2 listed)
- Patients aged 18 and over.
- Patients with at least one family member actively involved in the care process in the ICU.
Key exclusion criteria (4 listed)
- Patients with pre-existing cognitive impairment or dementia.
- Patients with severe traumatic brain injury.
- Patients with an expected mortality in the ICU of more than 80%.
- Absence of family members for patients admitted to the ICU.
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
Sedative dose
Time frame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.
It is the average daily dose of sedative drugs used by a patient. It will be calculated for each sedative drug. It will be calculated by dividing all doses taken by the number of days of hospitalization.
3 secondary outcomes
Delirium
Time frame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.
Ventilatory days
Time frame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.
Stay in intensive care unit
Time frame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Individual participant dataSharing planned: No. Ethics committee approval was not obtained for sharing patient data with an international database.
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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.
Oktay Demirkiran, Professor study director
İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty
Oguzhan Kayhan principal investigator
İstanbul University - Cerrahpaşa, Cerrahpaşa Medical Faculty
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 Intensive Care Patients and Relatives, run by Istanbul University - Cerrahpasa 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oguzhan Kayhan (0090 212 414 3000 ext. 63943, oguzhan.kayhan@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sedative dose (time frame: Each patient will be evaluated and recorded daily up to first 4 weeks of their stay in ICU.). 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 17 Jan 2025.