Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Treatment Intensity/Factors Predicting Short and Long Term Outcomes in Elderly Critically Ill Patients
This study is currently recruiting participants.
Verified by St. Luke's-Roosevelt Hospital Center, October 2007
Sponsored by: St. Luke's-Roosevelt Hospital Center
Information provided by: St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT00554684
  Purpose
  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. Patients greater than 90 years old will show lower levels of function than younger patients controlling for disease and acuity
  4. 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

Condition
Critically Ill Very Elderly Patients Admitted to ICU's

U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: Treatment Intensity and Factors Predicting Short and Long Term Outcomes in Elderly and Very Elderly Patients Admitted to Intensive Care Units

Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 399
Study Start Date: July 2007
Estimated Study Completion Date: July 2008
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Critically Ill Elderly Patients

Criteria

Inclusion Criteria:

  • Patients 65 year an older Admitted to MICU, SICU, and CCU

Exclusion Criteria:

  • Patients who refuse to complete HRQL questionaire while hospitalized
  • Subjects refuse to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00554684

Contacts
Contact: Hassan Khouli, MD 212 523 8914 hkhouli@chpnet.org

Locations
United States, New York
St. Luke's Roosevelt Hospital Recruiting
New York, New York, United States, 10019
Principal Investigator: Hassan Khouli, MD            
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Investigators
Principal Investigator: Hassan Khouli, MD St. Luke's-Roosevelt Hospital Center
  More Information

Study ID Numbers: 06-171
Study First Received: November 5, 2007
Last Updated: November 5, 2007
ClinicalTrials.gov Identifier: NCT00554684  
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Outcome
Elderly
ICU
Quality of Life

Study placed in the following topic categories:
Critical Illness
Quality of Life

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 15, 2009