Intensive Care Unit SyndromeDAARNCT02849756
Future of the Older Patients After Intensive Care Unit
An observational study of Intensive Care Unit Syndrome, run by Hôpital NOVO at 1 site in France.
Trial summary
Estimate the future six months after the admission in an intensive care unit of the patients of 85 and more years old in terms of autonomy. Read more about this study
- Who is it for?
- Ages 85 years and older
- Conditions the study is for
- Intensive Care Unit Syndrome
- What is being tested?
- older in intensive care unit
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Jun 2017
- 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 85 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients older than 85 years hospitalized in intensive care unit will be included in this study.
Who may be able to join
- All patients over 85 years old staying in intensive car units
Who cannot join
- Knaus D
- No possibly of call (phone) 6 months after ICU admission
- Patients who do not speak French
- Patients do not accept the participation
Trial locations and contacts
1 site in 1 country.
About this study
Estimate the future six months after the admission in an intensive care unit of the patients of 85 and more years old in terms of autonomy.
Read the detailed description
The diverse studies published on the future of the elderly hospitalized in resuscitation place the limit very low, between 65 and 80 years. The feeling of a very bad forecast at these extreme ages pulls nevertheless a filter in the admission in ICU which has this day no scientific justification. The knowledge of the evolution after the hospitalization of these older patients can help to make certain decisions concerning as well the admission of these patients in ICU as the realization of invasive treatments.
After informal interrogation of numerous intensivists, it seems to take shape a bar around 85 years beyond which the forecast would be worse without more proof what consolidated the choice of this limit.
The reserved scores were already used in similar studies (simplified ALD).
Primary purpose :
- Describe the survival and the evolution of the quality of life after a stay in resuscitation for very old patients.
- The quality of life will be studied through a score of autonomy: the simplified ALD score.
The population will be described in general then by age bracket (more or less of 90 years old), according to the length of stay in ICU, the heavy treatments (artificial ventilation, renal replacement therapy) practiced, the initial gravity (score IGS 2). The impact of possible decisions of Limitation or Stop of Therapeutic Activates will also be taken into account.
- Conditions
- Intensive Care Unit Syndrome
- Being tested
- older in intensive care unit
- Keywords
- Intensive care, elderly, autonomy, Future, older patients, intensive care unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
older in intensive care unitOther
It is an observational study with no intervention.
| Study group | Role | What they receive |
|---|---|---|
| older in intensive care unit | older (age superior at 85 years) hospitalized in intensive care unit. A follow-up until 6 months after hospitalization will determine the evolution of the quality of life and others secondary outcomes. Receives: Other: older in intensive care unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
ALD score
Geriatric score of autonomy
Measured: Six month
Secondary outcomes (1)
survival
survival
Measured: Six month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startFeb 2015
- Primary completionJun 2017
- Study completionJun 2017
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 Intensive Care Unit 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
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Dr MICHEL, PH, Principal investigator, René-Dubos Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849756
- Sponsor's protocol ID
- CHRD0514
- Acronym
- DAAR
- Status last verified
- Jul 2019
- First submitted
- 27 Jul 2016
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Khouli H, Astua A, Dombrowski W, Ahmad F, Homel P, Shapiro J, Singh J, Nallamothu R, Mahbub H, Eden E, Delfiner J. Changes in health-related quality of life and factors predicting long-term outcomes in older adults admitted to intensive care units. Crit Care Med. 2011 Apr;39(4):731-7. doi: 10.1097/CCM.0b013e318208edf8.
PubMed 21263318Lewis-Newby M, Curtis JR, Martin DP, Engelberg RA. Measuring family satisfaction with care and quality of dying in the intensive care unit: does patient age matter? J Palliat Med. 2011 Dec;14(12):1284-90. doi: 10.1089/jpm.2011.0138. Epub 2011 Nov 22.
PubMed 22107108Biston P, Aldecoa C, Devriendt J, Madl C, Chochrad D, Vincent JL, De Backer D. Outcome of elderly patients with circulatory failure. Intensive Care Med. 2014 Jan;40(1):50-6. doi: 10.1007/s00134-013-3121-7. Epub 2013 Oct 17.
PubMed 24132383
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Future of the Older Patients After Intensive Care Unit
- ClinicalTrials.gov ID
- NCT02849756
- Acronym / sponsor ID
- DAAR / CHRD0514
- Conditions
- Intensive Care Unit Syndrome
- Keywords
- Intensive care, elderly, autonomy, Future, older patients, intensive care unit
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 29 Jul 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.
Estimate the future six months after the admission in an intensive care unit of the patients of 85 and more years old in terms of autonomy.
Detailed description
The diverse studies published on the future of the elderly hospitalized in resuscitation place the limit very low, between 65 and 80 years. The feeling of a very bad forecast at these extreme ages pulls nevertheless a filter in the admission in ICU which has this day no scientific justification. The knowledge of the evolution after the hospitalization of these older patients can help to make certain decisions concerning as well the admission of these patients in ICU as the realization of invasive treatments.
After informal interrogation of numerous intensivists, it seems to take shape a bar around 85 years beyond which the forecast would be worse without more proof what consolidated the choice of this limit.
The reserved scores were already used in similar studies (simplified ALD).
Primary purpose :
- Describe the survival and the evolution of the quality of life after a stay in resuscitation for very old patients.
- The quality of life will be studied through a score of autonomy: the simplified ALD score.
The population will be described in general then by age bracket (more or less of 90 years old), according to the length of stay in ICU, the heavy treatments (artificial ventilation, renal replacement therapy) practiced, the initial gravity (score IGS 2). The impact of possible decisions of Limitation or Stop of Therapeutic Activates will also be taken into account.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| older in intensive care unit | – | Other: older in intensive care unitolder (age superior at 85 years) hospitalized in intensive care unit. A follow-up until 6 months after hospitalization will determine the evolution of the quality of life and others secondary outcomes. |
Who may qualify
- Ages
- 85 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients older than 85 years hospitalized in intensive care unit will be included in this study.
Key inclusion criteria (1 listed)
- All patients over 85 years old staying in intensive car units
Key exclusion criteria (4 listed)
- Knaus D
- No possibly of call (phone) 6 months after ICU admission
- Patients who do not speak French
- Patients do not accept the participation
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 |
|---|---|---|
| older in intensive care unitIt is an observational study with no intervention. | Other | older in intensive care unit |
Primary outcome
ALD score
Time frame: Six month
Geriatric score of autonomy
1 secondary outcome
survival
Time frame: Six month
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 29 Jul 2019.
- Background: PubMed 21263318Khouli H, Astua A, Dombrowski W, Ahmad F, Homel P, Shapiro J, Singh J, Nallamothu R, Mahbub H, Eden E, Delfiner J. Changes in health-related quality of life and factors predicting long-term outcomes in older adults admitted to intensive care units. Crit Care Med. 2011 Apr;39(4):731-7. doi: 10.1097/CCM.0b013e318208edf8.
- Background: PubMed 22107108Lewis-Newby M, Curtis JR, Martin DP, Engelberg RA. Measuring family satisfaction with care and quality of dying in the intensive care unit: does patient age matter? J Palliat Med. 2011 Dec;14(12):1284-90. doi: 10.1089/jpm.2011.0138. Epub 2011 Nov 22.
- Background: PubMed 24132383Biston P, Aldecoa C, Devriendt J, Madl C, Chochrad D, Vincent JL, De Backer D. Outcome of elderly patients with circulatory failure. Intensive Care Med. 2014 Jan;40(1):50-6. doi: 10.1007/s00134-013-3121-7. Epub 2013 Oct 17.
- 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.
Philippe Dr MICHEL, PH principal investigator
René-Dubos 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 Intensive Care Unit Syndrome, run by Hôpital NOVO at 1 site in France.
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 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: finished, as of the sponsor's last update on 29 Jul 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 France. 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?
ALD score (time frame: Six month). 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 NCT02849756, 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 29 Jul 2019.