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

This study is currently recruiting participants.
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

December 9, 2011
March 4, 2014
January 2012
January 2015   (final data collection date for primary outcome measure)
Mortality six months after emergency department visit [ Time Frame: 6 months after emergency department visit ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01508819 on ClinicalTrials.gov Archive Site
  • 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 ]
  • hospital mortality [ Time Frame: length of hospital stay ] [ 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 ]
Not Provided
Not Provided
 
Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments
Impact on Mid-term Mortality of Guidelines for ICU Admission of Elderly Patients Arriving in Emergency Departments: a Cluster Randomized Controlled Trial

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

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)

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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

Elderly Patients Visiting the Emergency Department
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
  • 1
    Guidelines for ICU admission of elderly patients arriving in Emergency Departments with a life threatening conditions
    Intervention: Other: recommendations to admit to ICU all the patients included
  • 2
    no intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2992
June 2015
January 2015   (final data collection date for primary outcome measure)

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
Both
75 Years and older
No
Contact: Bertrand Guidet, MD, PhD + 33 (0) 1 49 28 23 18 bertrand.guidet@sat.aphp.fr
France
 
NCT01508819
K100103
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Bertrand Guidet, PH Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP