Post Intensive Care SyndromeNCT02706457
Post Intensive Care Syndrome
An observational study of Post Intensive Care Syndrome and Barthel Index, run by Frisius Medisch Centrum at 1 site in Netherlands.
Trial summary
Barthel Index and demographic variables of patients were collected to investigate the question whether the improvements of the functionality improves the Barthel Index over the years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Syndrome, Barthel Index
- What is being tested?
- Barthel index for functionality
- How many people
- 849 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2015to Apr 2016
- 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: patients treated in Intensive Care for minimal 48 hours, during the years 2012 - 2014
Who may be able to join
- 18 years and older
- length of stay longer than 48 hours
Who cannot join
- no exclusion criteria if inclusion is correct
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Do Improvements in Functionality on the ICU Give a Reduction of Post Intensive Care Syndrome
Barthel Index and demographic variables of patients were collected to investigate the question whether the improvements of the functionality improves the Barthel Index over the years.
Read the detailed description
idem
- Conditions
- Post Intensive Care Syndrome, Barthel Index
- Being tested
- Barthel index for functionality
- Keywords
- intensive care, functionality
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Barthel index for functionalityOther
The Barthel Index for functionality is done standard in all patients after intensive care admission
| Study group | Role | What they receive |
|---|---|---|
| cohort 2012 - 2014 | all patients admitted for > 48 hours on the Intensive Care Unit in 2012, 2013 and 2014 Receives: Other: Barthel index for functionality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Barthel Index
barthel index is analyzed over the years 2012 - 2014
Measured: from januari 2012 until decembre 2014
Secondary outcomes (1)
Relation between Barthel Index and length of stay in ICU
Measured: from januari 2012 until decembre 2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2016 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care SyndromeStudies 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
- 849 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisius Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matty Koopmans, Frisius Medisch Centrum
- Investigators
- Matty Koopmans, MSc, Principal investigator, MCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02706457
- Sponsor's protocol ID
- nWMO 143
- Status last verified
- Apr 2016
- First submitted
- 16 Feb 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Improvements in Functionality on the ICU Give a Reduction of Post Intensive Care Syndrome
- ClinicalTrials.gov ID
- NCT02706457
- Acronym / sponsor ID
- nWMO 143
- Conditions
- Post Intensive Care Syndrome, Barthel Index
- Keywords
- intensive care, functionality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 849 participants (actual)
- Lead sponsor
- Frisius Medisch CentrumUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Mar 2016 (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.
Barthel Index and demographic variables of patients were collected to investigate the question whether the improvements of the functionality improves the Barthel Index over the years.
Detailed description
idem
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cohort 2012 - 2014 | – | Other: Barthel index for functionalityall patients admitted for > 48 hours on the Intensive Care Unit in 2012, 2013 and 2014 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated in Intensive Care for minimal 48 hours, during the years 2012 - 2014
Key inclusion criteria (2 listed)
- 18 years and older
- length of stay longer than 48 hours
Key exclusion criteria (1 listed)
- no exclusion criteria if inclusion is correct
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 |
|---|---|---|
| Barthel index for functionalityThe Barthel Index for functionality is done standard in all patients after intensive care admission | Other | cohort 2012 - 2014 |
Primary outcome
Difference in Barthel Index
Time frame: from januari 2012 until decembre 2014
barthel index is analyzed over the years 2012 - 2014
1 secondary outcome
Relation between Barthel Index and length of stay in ICU
Time frame: from januari 2012 until decembre 2014
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 12 Apr 2016.
- 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.
Matty Koopmans, MSc principal investigator
MCL
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 Post Intensive Care Syndrome and Barthel Index, run by Frisius Medisch Centrum at 1 site in Netherlands.
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 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 12 Apr 2016. 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 Netherlands. 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?
Difference in Barthel Index (time frame: from januari 2012 until decembre 2014). 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 12 Apr 2016.