Critically Ill Very Elderly Patients Admitted to ICU'sNCT00554684
Treatment Intensity/Factors Predicting Short and Long Term Outcomes in Elderly Critically Ill Patients
An observational study of Critically Ill Very Elderly Patients Admitted to ICU's, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
1. Patients greater than 90 years of age will have poorer outcomes in terms of mortality than younger patients controlling for disease and acuity 2. Patients greater than 90 years old will consume more resources than younger patients controlling for disease and acuity 3. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Critically Ill Very Elderly Patients Admitted to ICU's
- How many people
- 399 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Aug 2012
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Critically Ill Elderly Patients
Who may be able to join
- Patients 65 year an older Admitted to MICU, SICU, and CCU
Who cannot join
- Patients who refuse to complete HRQL questionaire while hospitalized
- Subjects refuse to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Roosevelt Hospital
New York, New York, 10019
About this study
Official title: Treatment Intensity and Factors Predicting Short and Long Term Outcomes in Elderly and Very Elderly Patients Admitted to Intensive Care Units
- Patients greater than 90 years of age will have poorer outcomes in terms of mortality than younger patients controlling for disease and acuity
- Patients greater than 90 years old will consume more resources than younger patients controlling for disease and acuity
- Patients greater than 90 years old will show lower levels of function than younger patients controlling for disease and acuity
- Patients greater than 90 years old will show lower levels of HRQOL at 90-120 days post ICU discharge than younger patients controlling for disease and acuity
Read the detailed description
Elderly patients make up between 26% and 51% of patients who are admitted to ICUs. The proportion of individuals in North America aged > 65 is projected to increase to 20% of the population by 2026. As population demographics change, and as new technologies, pharmaceuticals, and interventions prolong lives, the proportion of elderly patients admitted to ICUs and surviving ICU stay will continue to increase. Studies that have examined only ICU or hospital survival as an outcome have had variable results. Few studies have demonstrated that elderly ICU patients experience higher mortality rates, while others have demonstrated that age alone, when adjusted for other factors, is not an important prognostic indicator among elderly patients admitted to the intensive care units (ICU). However, age is still used as an important criteria for admission to ICUs. Most studies reviewed have looked at patients sixty-five to ninety years old. To our knowledge only two studies to date have addressed this issue among patients older than 90 to an ICU, both were retrospective.
With increasing age there is a parallel increase in health care costs. The use of expensive technology and procedures in the very elderly is fast becoming a major concern. Data on resource allocation and treatment intensity in the (90+) subgroup is sparse.
Beyond mortality and cost, health-related quality of life (HRQOL) is a fundamentally important end point of medical care. Few studies have addressed outcomes in terms of HRQOL and functional status of elderly following discharge the from critical care unit. These studies were limited by small number of subjects enrolled, retrospective design, and lack of validated tool to assess HRQOL.
We plan to prospectively collect data to look at determinants of treatment intensity, outcome, and resource allocation in elderly patients ages 65 and above admitted to the ICU with care taken to including as many patients in the age interval above 90 years of age. We will also assess HRQOL and functional status in very elderly patients who survive admission and are discharged from the hospital.
- Keywords
- Outcome, Elderly, ICU, Quality of Life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2007 (estimated)
- Study startJul 2007
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically Ill Very Elderly Patients Admitted to ICU'sStudies 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
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hassan Khouli, St. Luke's-Roosevelt Hospital Center
- Investigators
- Hassan Khouli, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00554684
- Sponsor's protocol ID
- 06-171
- Status last verified
- Aug 2012
- First submitted
- 5 Nov 2007
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Intensity and Factors Predicting Short and Long Term Outcomes in Elderly and Very Elderly Patients Admitted to Intensive Care Units
- ClinicalTrials.gov ID
- NCT00554684
- Acronym / sponsor ID
- 06-171
- Keywords
- Outcome, Elderly, ICU, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Jul 2007
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Nov 2007 (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.
- Patients greater than 90 years of age will have poorer outcomes in terms of mortality than younger patients controlling for disease and acuity
- Patients greater than 90 years old will consume more resources than younger patients controlling for disease and acuity
- Patients greater than 90 years old will show lower levels of function than younger patients controlling for disease and acuity
- Patients greater than 90 years old will show lower levels of HRQOL at 90-120 days post ICU discharge than younger patients controlling for disease and acuity
Detailed description
Elderly patients make up between 26% and 51% of patients who are admitted to ICUs. The proportion of individuals in North America aged > 65 is projected to increase to 20% of the population by 2026. As population demographics change, and as new technologies, pharmaceuticals, and interventions prolong lives, the proportion of elderly patients admitted to ICUs and surviving ICU stay will continue to increase. Studies that have examined only ICU or hospital survival as an outcome have had variable results. Few studies have demonstrated that elderly ICU patients experience higher mortality rates, while others have demonstrated that age alone, when adjusted for other factors, is not an important prognostic indicator among elderly patients admitted to the intensive care units (ICU). However, age is still used as an important criteria for admission to ICUs. Most studies reviewed have looked at patients sixty-five to ninety years old. To our knowledge only two studies to date have addressed this issue among patients older than 90 to an ICU, both were retrospective.
With increasing age there is a parallel increase in health care costs. The use of expensive technology and procedures in the very elderly is fast becoming a major concern. Data on resource allocation and treatment intensity in the (90+) subgroup is sparse.
Beyond mortality and cost, health-related quality of life (HRQOL) is a fundamentally important end point of medical care. Few studies have addressed outcomes in terms of HRQOL and functional status of elderly following discharge the from critical care unit. These studies were limited by small number of subjects enrolled, retrospective design, and lack of validated tool to assess HRQOL.
We plan to prospectively collect data to look at determinants of treatment intensity, outcome, and resource allocation in elderly patients ages 65 and above admitted to the ICU with care taken to including as many patients in the age interval above 90 years of age. We will also assess HRQOL and functional status in very elderly patients who survive admission and are discharged from the hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Critically Ill Elderly Patients
Key inclusion criteria (1 listed)
- Patients 65 year an older Admitted to MICU, SICU, and CCU
Key exclusion criteria (2 listed)
- Patients who refuse to complete HRQL questionaire while hospitalized
- Subjects refuse to participate
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
Not reported in the source record.
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 Aug 2012.
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.
Hassan Khouli, MD principal investigator
St. Luke's-Roosevelt Hospital Center
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 Critically Ill Very Elderly Patients Admitted to ICU's, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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 2 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 Aug 2012. 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 United States. 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.
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 Aug 2012.