Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments (ICECUBII)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01508819
First received: December 9, 2011
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

Admitting a very elderly patient to the Intensive Care Unit (ICU) is one of the most difficult clinical challenges in medicine. There are few data to help guide clinicians in this area: estimates of the benefits of ICU admission, especially in the very elderly, are sparse. Rates of ICU admission of very elderly thus vary widely by hospitals.

The ICE-CUB1 (PHRC AOR 03 035) project has studied the ICU admission decision process of patients over 80 arriving in Emergency Departments (ED) with conditions that potentially warrant ICU admission and their outcome six months after ED visit. Overall rate of patients deemed eligible for ICU admission was of 12% (Garrouste et al. Crit Care Med 2009) but ranged from 5% to 38% across the participating centers. This variability persisted after adjustment for patients' characteristics (MOR 2.25, 1.60-3.58; hospital-related variance 18%). The analysis also revealed that high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and the absence of cancer were of good prognosis for outcome six months after ED visit. Only 23% of patients visiting the ED with a life-threatening condition and all positive prognostic factors mentioned above were admitted to an ICU in the ICE-CUB1 study.

Hypothesis Elderly patients visiting the ED with a life-threatening condition, high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and no cancer will potentially benefit from ICU care and should thus be admitted.

Main objective Determine whether a strategy consisting of recommendations of ICU admission of all patients over 75 visiting the ED with a life threatening condition, no cancer, good functional and nutritional status prior to ED visit decreases the mortality of these patients six months after ED visit.

Secondary objective : Assess the impact of the strategy on:

  • In-hospital mortality
  • Rate of ICU admission
  • Place of living and quality of life six months after ED visit

Primary outcome :Mortality six months after ED visit Secondary outcomes

  • In-hospital mortality
  • ICU admission
  • Change in functional status six months after ED visit
  • institutionalization
  • Quality of life six months after ED visit

Condition Intervention
Elderly Patients Visiting the Emergency Department
Other: recommendations to admit to ICU all the patients included

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments: a Cluster Randomized Controlled Trial

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Mortality six months after emergency department visit [ Time Frame: 6 months after emergency department visit ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • hospital mortality [ Time Frame: up to 6 months ] [ Designated as safety issue: Yes ]
  • ICU admission rate [ Time Frame: length of hospital stay ] [ Designated as safety issue: No ]
  • change in functional status [ Time Frame: 6 months after emergency department visit ] [ Designated as safety issue: No ]
  • institutionalization [ Time Frame: 6 months after emergency department visit ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 6 months after emergency department visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 2992
Study Start Date: January 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Guidelines for ICU admission of elderly patients arriving in Emergency Departments with a life threatening conditions
Other: recommendations to admit to ICU all the patients included
recommendations to emergency and ICU physicians to admit to ICU all the patients included in the trial
Other Name: recommendations to admit to ICU all the patients included
2
no intervention

Detailed Description:

Admitting a very elderly patient to the Intensive Care Unit (ICU) is one of the most difficult clinical challenges in medicine. There are few data to help guide clinicians in this area: estimates of the benefits of ICU admission, especially in the very elderly, are sparse. Rates of ICU admission of very elderly thus vary widely by hospitals.

The ICE-CUB1 (PHRC AOR 03 035) project has studied the ICU admission decision process of patients over 80 arriving in Emergency Departments (ED) with conditions that potentially warrant ICU admission and their outcome six months after ED visit. Overall rate of patients deemed eligible for ICU admission was of 12% (Garrouste et al. Crit Care Med 2009) but ranged from 5% to 38% across the participating centers. This variability persisted after adjustment for patients' characteristics (MOR 2.25, 1.60-3.58; hospital-related variance 18%). The analysis also revealed that high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and the absence of cancer were of good prognosis for outcome six months after ED visit. Only 23% of patients visiting the ED with a life-threatening condition and all positive prognostic factors mentioned above were admitted to an ICU in the ICE-CUB1 study.

Hypothesis Elderly patients visiting the ED with a life-threatening condition, high functional status prior to ICU visit, good nutritional status as assessed by an emergency physician and no cancer will potentially benefit from ICU care and should thus be admitted.

Main objective Determine whether a strategy consisting of recommendations of ICU admission of all patients over 75 visiting the ED with a life threatening condition, no cancer, good functional and nutritional status prior to ED visit decreases the mortality of these patients six months after ED visit.

Secondary objective : Assess the impact of the strategy on:

  • In-hospital mortality
  • Rate of ICU admission
  • Place of living and quality of life six months after ED visit

Primary outcome :Mortality six months after ED visit Secondary outcomes

  • In-hospital mortality
  • ICU admission
  • Change in functional status six months after ED visit
  • institutionalization
  • Quality of life six months after ED visit

Type of study Cluster stratified randomized controlled trial. Stratification criteria are existence of an acute geriatric ward, capacity of the emergency department and location of the hospital (in or out Paris area)

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients over 75 visiting the emergency department with a condition potentially warranting intensive care unit admission

Criteria

Inclusion Criteria:

  • Age over 75 years old
  • At least one organ failure
  • No cachexia
  • No active known cancer
  • Good functional status (as assessed by an ADL score > 4) or not evaluable
  • Affiliated to social security

Exclusion Criteria:

  • refusal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01508819

Contacts
Contact: Bertrand Guidet, MD, PhD + 33 (0) 1 49 28 23 18 bertrand.guidet@sat.aphp.fr

Locations
France
ICU - Saint-Antoine Hospital Recruiting
Paris, France, 75012
Contact: Bertrand Guidet, MD, PhD    + 33 (0) 1 49 28 23 18    bertrand.guidet@sat.aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Bertrand Guidet, PH Assistance Publique - Hôpitaux de Paris
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01508819     History of Changes
Other Study ID Numbers: K100103
Study First Received: December 9, 2011
Last Updated: March 4, 2014
Health Authority: France: French Data Protection Authority

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Patients over 75
acute pathology
ICU admission

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014