Critical IllnessNCT06373068
Association Between Resuscitation Orders and Mortality in ICU Patients
An observational study of Critical Illness, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Resuscitation orders
- How many people
- 1,500 participants
- Where
- 1 siteSweden
- Study dates
- 1 May 2024to Dec 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill patients admitted to the intensive care unit during 2023 and 2024
Who may be able to join
- Admitted to ICU
Who cannot join
- Second or subsequent admission to ICU during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study of the Association of Different Levels of Resuscitation Orders and Mortality in ICU Patients.
The hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty Scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained.
- Conditions
- Critical Illness
- Being tested
- Resuscitation orders
- Keywords
- Resuscitation orders
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resuscitation ordersOther
Resuscitation orders, commonly referred to as Code Status, communicate to the healthcare team the specific medical interventions that patients will receive while hospitalised. These orders are issued by a doctor and require confirmation by at least one other licensed medical professional
| Study group | Role | What they receive |
|---|---|---|
| Full code | Patients without any restrictions on the types of treatments available, such as cardiopulmonary resuscitation, intubation, various life support measures, surgery, etc., if indicated. Receives: Other: Resuscitation orders | |
| Simple Do-Not-Attempt-Resuscitation | The only treatment limitation in patient care is cardiopulmonary resuscitation in case of a cardiac arrest. All other indicated devices or treatments may still be utilized. Receives: Other: Resuscitation orders | |
| Do not attempt resuscitation with limited scope | The treatment limitation in patient care includes not performing cardiopulmonary resuscitation and also involve additional limitations, typically including various life support measures. Receives: Other: Resuscitation orders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Hazard ratio of death
Measured: 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 May 2024
- Primary completion28 Feb 2025
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- Retrospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Jonmarker, Karolinska Institutet
- Investigators
- Sandra Jonmarker, Principal investigator, Stockholm South General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373068
- Sponsor's protocol ID
- Resuscitation Orders ICU
- Status last verified
- Aug 2025
- First submitted
- 15 Apr 2024
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The privacy of the data is protected under Swedish law, and the original patient data will be stored in a de-identified form for 10 years in accordance with Karolinska Institute regulations. Use of the de-identified data for research purposes beyond those specified in this registration may be considered, but requires additional approval from the Swedish Ethics Committee.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study of the Association of Different Levels of Resuscitation Orders and Mortality in ICU Patients.
- ClinicalTrials.gov ID
- NCT06373068
- Acronym / sponsor ID
- Resuscitation Orders ICU
- Conditions
- Critical Illness
- Keywords
- Resuscitation orders
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 18 Apr 2024 (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 hypothesis of the study is that a resuscitation order other than full code is associated with increased mortality among critically ill patients. By incorporating conventional variables associated with death such as age, sex, and Simplified Acute Physiological Score, as well as including the new Clinical Frailty Scale in a statistical model, the aim is to investigate whether there is still an increased risk of death that remains unexplained.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Full code | – | Other: Resuscitation ordersPatients without any restrictions on the types of treatments available, such as cardiopulmonary resuscitation, intubation, various life support measures, surgery, etc., if indicated. |
| Simple Do-Not-Attempt-Resuscitation | – | Other: Resuscitation ordersThe only treatment limitation in patient care is cardiopulmonary resuscitation in case of a cardiac arrest. All other indicated devices or treatments may still be utilized. |
| Do not attempt resuscitation with limited scope | – | Other: Resuscitation ordersThe treatment limitation in patient care includes not performing cardiopulmonary resuscitation and also involve additional limitations, typically including various life support measures. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients admitted to the intensive care unit during 2023 and 2024
Key inclusion criteria (1 listed)
- Admitted to ICU
Key exclusion criteria (1 listed)
- Second or subsequent admission to ICU during the study period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resuscitation ordersResuscitation orders, commonly referred to as Code Status, communicate to the healthcare team the specific medical interventions that patients will receive while hospitalised. These orders are issued by a doctor and require confirmation by at least one other licensed medical professional | Other | Do not attempt resuscitation with limited scope, Full code, Simple Do-Not-Attempt-Resuscitation |
Primary outcome
Mortality
Time frame: 365 days
Hazard ratio of death
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 4 Sep 2025.
- Individual participant dataSharing planned: Undecided. The privacy of the data is protected under Swedish law, and the original patient data will be stored in a de-identified form for 10 years in accordance with Karolinska Institute regulations. Use of the de-identified data for research purposes beyond those specified in this registration may be considered, but requires additional approval from the Swedish Ethics Committee.
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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.
Sandra Jonmarker principal investigator
Stockholm South General Hospital
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 Karolinska Institutet at 1 site in Sweden.
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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 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 Sweden. 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?
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?
Mortality (time frame: 365 days). 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 4 Sep 2025.