PneumoniapneumoniaNCT02212093
5 Years Mortality-rate in Patients Treated for Severe Pneumonia in an ICU - a Retrospective Study
An observational study of Pneumonia, run by University Hospital, Akershus at 1 site in Norway.
Trial summary
Severe pneumonia has a high in-hospital mortality. There are few studies which investigate the long-term mortality in patients that are discharged alive from the hospital. In this study we want to investigate the 5 years mortality after treatment of severe pneumonia in an ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- How many people
- 236 participants
- Where
- 1 siteNorway
- Study dates
- Jun 2014to Feb 2015
- 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 same as the inclusion criteria
Who may be able to join
- Patients > 18 years. Primary diagnose: pneumonia, and the need of mechanical ventilation for at least 24 hours in an ICU. The patients who arrived the ICU in Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.
Who cannot join
- Patients < 18 years. Patients with need for mechanical ventilation < 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cause-specific 5 Years Mortality-rate in Patients Treated for Severe Pneumonia in an ICU - a Retrospective Study
Severe pneumonia has a high in-hospital mortality. There are few studies which investigate the long-term mortality in patients that are discharged alive from the hospital. In this study we want to investigate the 5 years mortality after treatment of severe pneumonia in an ICU. We will also investigate the cause of death after discharge from the hospital.
Read the detailed description
Patients with severe pneumonia who need treatment in an ICU have a high in-hospital mortality (16-46%). There are few studies which investigate the long-term mortality (> 1year) in patients after discharge from the hospital. There seems to be a higher mortality in this group compared to the general population. The cause(s) of this higher long-term mortality is unclear and few studies have investigated this problem.
We are going to investigate the 5 years mortality rate in this population of patients. We are also going to investigate the cause of death in the patients who are discharged from the hospital alive.
Inclusion criteria: Patients > 18 years. Primary diagnose: pneumonia, and the need of mechanical ventilation for at least 24 hours in an ICU. The patients who arrive at the ICU in Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.
The datas are collected from the patients' journals and the local ICU register. Collecting data: Age, sex, comorbidity, SAPSII, mechanical ventilation time, stay in the ICU, stay in the hospital, ICU mortality, hospital mortality, 5 years mortality, type of pneumonia (bacteriology).
Time of death after discharge is collected from Norwegian National Registry. Cause of death after discharge is collected from Norwegian Institute of Public Health.
- Conditions
- Pneumonia
- Keywords
- Pneumonia, mechanical ventilation, ICU, mortality
- Medical subject headings
- Pneumonia
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 |
|---|---|---|
| pneumonia and mechanical ventilation | The data are collected retrospectively from this one group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
5 years mortality
Measured: 5 years
Secondary outcomes (1)
cause of death after discharge from the hospital
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies 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
- Time perspective
- Retrospective
- Enrolment
- 236 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Akershus
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital
- Responsible party
- Principal investigator, Vegard Dahl, University Hospital, Akershus
- Investigators
- Vegard Dahl, Professor, Principal investigator, University Hospital, Akershus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212093
- Sponsor's protocol ID
- 2013/2338
- Acronym
- pneumonia
- Status last verified
- Jul 2015
- First submitted
- 7 Aug 2014
- Last updated
- 23 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cause-specific 5 Years Mortality-rate in Patients Treated for Severe Pneumonia in an ICU - a Retrospective Study
- ClinicalTrials.gov ID
- NCT02212093
- Acronym / sponsor ID
- pneumonia / 2013/2338
- Conditions
- Pneumonia
- Keywords
- Pneumonia, mechanical ventilation, ICU, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 236 participants (actual)
- Lead sponsor
- University Hospital, AkershusUniversity, hospital or other
- Collaborators
- Oslo University Hospital
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 8 Aug 2014 (estimated)
- 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.
Severe pneumonia has a high in-hospital mortality. There are few studies which investigate the long-term mortality in patients that are discharged alive from the hospital. In this study we want to investigate the 5 years mortality after treatment of severe pneumonia in an ICU. We will also investigate the cause of death after discharge from the hospital.
Detailed description
Patients with severe pneumonia who need treatment in an ICU have a high in-hospital mortality (16-46%). There are few studies which investigate the long-term mortality (> 1year) in patients after discharge from the hospital. There seems to be a higher mortality in this group compared to the general population. The cause(s) of this higher long-term mortality is unclear and few studies have investigated this problem.
We are going to investigate the 5 years mortality rate in this population of patients. We are also going to investigate the cause of death in the patients who are discharged from the hospital alive.
Inclusion criteria: Patients > 18 years. Primary diagnose: pneumonia, and the need of mechanical ventilation for at least 24 hours in an ICU. The patients who arrive at the ICU in Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.
The datas are collected from the patients' journals and the local ICU register. Collecting data: Age, sex, comorbidity, SAPSII, mechanical ventilation time, stay in the ICU, stay in the hospital, ICU mortality, hospital mortality, 5 years mortality, type of pneumonia (bacteriology).
Time of death after discharge is collected from Norwegian National Registry. Cause of death after discharge is collected from Norwegian Institute of Public Health.
Study design
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pneumonia and mechanical ventilation | – | –The data are collected retrospectively from this one group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The same as the inclusion criteria
Key inclusion criteria (1 listed)
- Patients > 18 years. Primary diagnose: pneumonia, and the need of mechanical ventilation for at least 24 hours in an ICU. The patients who arrived the ICU in Akershus University Hospital in the period from 01.01.1997 to 31.12.2006.
Key exclusion criteria (1 listed)
- Patients < 18 years. Patients with need for mechanical ventilation < 24 hours
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
5 years mortality
Time frame: 5 years
1 secondary outcome
cause of death after discharge from the hospital
Time frame: 5 years
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 23 Jul 2015.
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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.
Vegard Dahl, Professor principal investigator
University Hospital, Akershus
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 Pneumonia, run by University Hospital, Akershus at 1 site in Norway.
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 23 Jul 2015. 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 Norway. 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?
5 years mortality (time frame: 5 years). 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 23 Jul 2015.