Critical CareDEFAULTNCT03789305
Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes
An observational study of Critical Care and Rehabilitation, run by Technical University of Munich at 1 site in Germany.
Trial summary
This is a prospective analysis of patient registry data of intensive care patients. The aim is to investigate if frailty is a predictor of decline of functional status of critically ill patients during their hospital stay. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Rehabilitation, Outcome Assessment
- How many people
- 731 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2017to 31 May 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: Critically ill patients admitted to two intensive care units at a university hospital from the Department of Anesthesiology and Intensive Care in Munich, Germany.
Who may be able to join
- intensive care stay > 48 hours
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinikum rechts der Isar, School of Medicine, Technical University of Munich
Munich, Bavaria, 81675
About this study
This is a prospective analysis of patient registry data of intensive care patients. The aim is to investigate if frailty is a predictor of decline of functional status of critically ill patients during their hospital stay.
Read the detailed description
Elderly critical-ill patients with a high frailty level are becoming increasingly important in the ICU and the health system. Especially, questions about the course of the individual proceeding, withhold of therapy and level of care are controversial among caretakers, as outcome and functional independence remain still unclear in these patients.
This applies particularly in view of the fact that large studies such as VIP1 showed an inverse association of high frailty classes with short-term survival.
Our main objective in this study was to focus on functional outcome and independency measured by Barthel Index after ICU stay regarding frailty, the effect of critical care and severity and prognosis of the disease.
- Conditions
- Critical Care, Rehabilitation, Outcome Assessment, Critical Illness, Frailty, Physical and Rehabilitation Medicine
- Keywords
- Early Mobilization, Early Rehabilitation, Functional Status, Functional Outcome, Patient Outcome, Intensive Care, Critical Care Outcomes
- Medical subject headings
- Critical Illness, Frailty
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 |
|---|---|---|
| Critically ill patients | Critically ill patients admitted to intensive care for more than 48 hours |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probability not to deteriorate in functional status during the hospital stay
Analysis of the course of functional status measured by the Barthel Score sub-components transfer and ambulation during the hospital stay. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.
Measured: a median of 30 days
Secondary outcomes (7)
Change in Functional status before hospital admission to ICU discharge
Analysis of the change of functional status measured by the Barthel Score sub-components transfer and ambulation from before hospital admission to ICU discharge. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.
Measured: a median of 20 days
Change in Functional status before hospital admission to hospital discharge
Analysis of the change of functional status measured by the Barthel Score sub-components transfer and ambulation from before hospital admission to hospital discharge. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.
Measured: a median of 30 days
ICU length of stay
Duration of stay on intensive care
Measured: a median of 11 days
Hospital length of stay
Duration of stay in the hospital
Measured: a median of 30 days
Rate of discharge disposition to home
Rate of participants being discharged home after the hospital stay.
Measured: 1 day
ICU mortality
Expired during the intensive care stay
Measured: a median of 11 days
Hospital mortality
Expired during the hospital stay
Measured: a median of 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2018
- Study start1 Apr 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe 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
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Schaller, Technical University of Munich
- Investigators
- Stefan J Schaller, MD, MHBA, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03789305
- Sponsor's protocol ID
- DEFAULT
- Acronym
- DEFAULT
- Status last verified
- Jan 2019
- First submitted
- 25 Dec 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data will be made available to other researchers on reasonable request. A data share agreement will have to be signed by both parties. Examples of reasonable requests are: * a metaanalysis in the field * a research collaboration * rerun the analysis Data will only be provided for the purpose requested and may not be used otherwise without authorization/agreement.
Publications
Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
PubMed 23395245Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.
PubMed 28936626Latronico N, Herridge M, Hopkins RO, Angus D, Hart N, Hermans G, Iwashyna T, Arabi Y, Citerio G, Ely EW, Hall J, Mehta S, Puntillo K, Van den Hoeven J, Wunsch H, Cook D, Dos Santos C, Rubenfeld G, Vincent JL, Van den Berghe G, Azoulay E, Needham DM. The ICM research agenda on intensive care unit-acquired weakness. Intensive Care Med. 2017 Sep;43(9):1270-1281. doi: 10.1007/s00134-017-4757-5. Epub 2017 Mar 13.
PubMed 28289812
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes
- ClinicalTrials.gov ID
- NCT03789305
- Acronym / sponsor ID
- DEFAULT / DEFAULT
- Conditions
- Critical Care, Rehabilitation, Outcome Assessment, Critical Illness, Frailty, Physical and Rehabilitation Medicine
- Keywords
- Early Mobilization, Early Rehabilitation, Functional Status, Functional Outcome, Patient Outcome, Intensive Care, Critical Care Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 28 Dec 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.
This is a prospective analysis of patient registry data of intensive care patients. The aim is to investigate if frailty is a predictor of decline of functional status of critically ill patients during their hospital stay.
Detailed description
Elderly critical-ill patients with a high frailty level are becoming increasingly important in the ICU and the health system. Especially, questions about the course of the individual proceeding, withhold of therapy and level of care are controversial among caretakers, as outcome and functional independence remain still unclear in these patients.
This applies particularly in view of the fact that large studies such as VIP1 showed an inverse association of high frailty classes with short-term survival.
Our main objective in this study was to focus on functional outcome and independency measured by Barthel Index after ICU stay regarding frailty, the effect of critical care and severity and prognosis of the disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | –Critically ill patients admitted to intensive care for more than 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients admitted to two intensive care units at a university hospital from the Department of Anesthesiology and Intensive Care in Munich, Germany.
Key inclusion criteria (1 listed)
- intensive care stay > 48 hours
Key exclusion criteria (1 listed)
- none
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
Probability not to deteriorate in functional status during the hospital stay
Time frame: a median of 30 days
Analysis of the course of functional status measured by the Barthel Score sub-components transfer and ambulation during the hospital stay. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.
7 secondary outcomes
Change in Functional status before hospital admission to ICU discharge
Time frame: a median of 20 days
Change in Functional status before hospital admission to hospital discharge
Time frame: a median of 30 days
ICU length of stay
Time frame: a median of 11 days
Hospital length of stay
Time frame: a median of 30 days
Rate of discharge disposition to home
Time frame: 1 day
ICU mortality
Time frame: a median of 11 days
Hospital mortality
Time frame: a median of 22 days
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 Jan 2019.
- Background: PubMed 23395245Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.
- Background: PubMed 28936626Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.
- Background: PubMed 28289812Latronico N, Herridge M, Hopkins RO, Angus D, Hart N, Hermans G, Iwashyna T, Arabi Y, Citerio G, Ely EW, Hall J, Mehta S, Puntillo K, Van den Hoeven J, Wunsch H, Cook D, Dos Santos C, Rubenfeld G, Vincent JL, Van den Berghe G, Azoulay E, Needham DM. The ICM research agenda on intensive care unit-acquired weakness. Intensive Care Med. 2017 Sep;43(9):1270-1281. doi: 10.1007/s00134-017-4757-5. Epub 2017 Mar 13.
- Individual participant dataSharing planned: Undecided. Anonymized data will be made available to other researchers on reasonable request. A data share agreement will have to be signed by both parties. Examples of reasonable requests are: * a metaanalysis in the field * a research collaboration * rerun the analysis Data will only be provided for the purpose requested and may not be used otherwise without authorization/agreement.
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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.
Stefan J Schaller, MD, MHBA principal investigator
Technical University of Munich
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 Care and Rehabilitation, run by Technical University of Munich at 1 site in Germany.
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 Jan 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 Germany. 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?
Probability not to deteriorate in functional status during the hospital stay (time frame: a median of 30 days). 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 NCT03789305, which also lists 3 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 23 Jan 2019.