NCT01293708

Brief Summary

The purpose of this study is to understand the realities, expectations and attitudes of patients 80+ and their families about the use of life-sustaining technology, and to document the patient outcomes and family experiences associated with surviving and not surviving critical illness. Specifically in this project the investigators will determine the real outcomes of critical illness experienced by octogenarians.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,504

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2009

Typical duration for all trials

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

December 16, 2020

Status Verified

December 1, 2020

Enrollment Period

3.4 years

First QC Date

February 10, 2011

Last Update Submit

December 11, 2020

Conditions

Keywords

OctogenariansHRQOLmortalityprospective observationalElderly

Outcome Measures

Primary Outcomes (1)

  • Health Related Quality of Life (HRQOL)

    To determine the 12 month HRQOL of 80+ year olds admitted to the ICU in Canada.

    12 months

Secondary Outcomes (3)

  • To determine which patient characteristics are associated with 12-month HRQOL

    12 month

  • To determine which patient characteristics are associated with functional status.

    12 months

  • To determine which patient characteristics are associated with survival

    12 months

Study Arms (2)

Hospital Cohort

All 80+ year old that had had an ICU stay of \>=24 hrs. Followed until hospital d/c

Longitudinal Cohort

All 80+ year old that had had an ICU stay of \>=24 hrs. Followed for 12 months

Eligibility Criteria

Age80 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

80+ year old admitted to ICU

You may qualify if:

  • minimum stay in the ICU of 24 hrs
  • patient is \>=80 years old
  • patient is a resident of Canada and has a permanent address in this country
  • patient has an eligible family caregiver who has visited the patient at least once within 96 hours of the current ICU admission

You may not qualify if:

  • family caregiver is \<= 18
  • family caregiver is paid to do so
  • family caregivers that do not speak English or French
  • previously enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Peter Lougheed Hospital

Calgary, Alberta, T1Y 6J4, Canada

Location

Foothills Hospital

Calgary, Alberta, T2N 2T9, Canada

Location

University of Alberta Hospital

Calgary, Alberta, T6G 2B7, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, T5H 1A8, Canada

Location

Grey Nuns Community Hospital

Edmonton, Alberta, T6T 0Z0, Canada

Location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W4, Canada

Location

Surrey Memorial Hospital

Surrey, British Columbia, V3W, Canada

Location

St.Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Royal Jubilee Hospital

Vancouver, British Columbia, V8R 1J8, Canada

Location

Victoria General Hospital

Vancouver, British Columbia, V8Z 6R5, Canada

Location

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Winnipeg Health Sciences Center

Winnipeg, Manitoba, R3A 1R9, Canada

Location

St. Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

Ottawa Hospital

Ottawa, Ontario, K1Y 4E9, Canada

Location

Sunnybrook Health Sciences

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michaels Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Mount Sinai

Toronto, Ontario, M5G 1X5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Hospital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Hospital de Sacre-Coeur

Montreal, Quebec, H4J 1C5, Canada

Location

Departement d'Anesthesie

Québec, Quebec, G1J 1Z4, Canada

Location

Hospital Laval

Québec, Quebec, G1V 4G5, Canada

Location

Royal University Hospital

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Related Publications (4)

  • Chin-Yee N, D'Egidio G, Thavorn K, Heyland D, Kyeremanteng K. Cost analysis of the very elderly admitted to intensive care units. Crit Care. 2017 May 16;21(1):109. doi: 10.1186/s13054-017-1689-y.

  • Heyland DK, Garland A, Bagshaw SM, Cook D, Rockwood K, Stelfox HT, Dodek P, Fowler RA, Turgeon AF, Burns K, Muscedere J, Kutsogiannis J, Albert M, Mehta S, Jiang X, Day AG. Recovery after critical illness in patients aged 80 years or older: a multi-center prospective observational cohort study. Intensive Care Med. 2015 Nov;41(11):1911-20. doi: 10.1007/s00134-015-4028-2. Epub 2015 Aug 26.

  • Heyland D, Cook D, Bagshaw SM, Garland A, Stelfox HT, Mehta S, Dodek P, Kutsogiannis J, Burns K, Muscedere J, Turgeon AF, Fowler R, Jiang X, Day AG; Canadian Critical Care Trials Group; Canadian Researchers at the End of Life Network. The Very Elderly Admitted to ICU: A Quality Finish? Crit Care Med. 2015 Jul;43(7):1352-60. doi: 10.1097/CCM.0000000000001024.

  • Heyland DK, Dodek P, Mehta S, Cook D, Garland A, Stelfox HT, Bagshaw SM, Kutsogiannis DJ, Burns K, Muscedere J, Turgeon AF, Fowler R, Jiang X, Day AG; Canadian Critical Care Trials Group and Canadian Researchers at End of Life Network (CARENET). Admission of the very elderly to the intensive care unit: family members' perspectives on clinical decision-making from a multicenter cohort study. Palliat Med. 2015 Apr;29(4):324-35. doi: 10.1177/0269216314566060. Epub 2015 Feb 2.

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daren Heyland, MD

    Clinical Evaluation Research Unit,, Kingston General Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. Daren Heyland

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

September 1, 2009

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

December 16, 2020

Record last verified: 2020-12

Locations