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Outcomes of Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis (ANGIOCHOLREA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03831529
Recruitment Status : Completed
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

Brief Summary:

The aging of the population goes along with an increased demand for intensive care among very elderly patients (above 75-80 years old). At the same time, there is a decline in the supply of intensive care units (ICU). The 1-year mortality of patients above 80 years old in ICU ranged from 40 to 70%. Moreover, many survivors suffer from long-term sequelae as poor quality of life, cognitive impairment and functional disability.

It is unclear under what conditions older patients may benefit from ICU admission. Cholangitis frequently occured in older patient. Moreover, severe acute cholangitis is a potentially life threatening disease characterized by a biliary obstruction and an infection of the bile possibly evolving towards systemic infection, shock and death. Because of its potential rapid reversibility of symptom thanks to early intravenous antibiotics and biliary decompression with drainage, old patients suffering from acute cholangitis are easily admitted to intensive care unit.

To date, there is a lack of data about the outcome in this population admitted to the intensive care unit with acute cholangitis.

The aim of the current study is to describe the outcomes in elderly patients (> 75 years old) admitted to the ICU with acute cholangitis and to identify prognostics factors associated with long term mortality (6 months).


Condition or disease
Cholangitis Infective Elderly Person

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Study Type : Observational
Actual Enrollment : 204 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Prognostic Factors Associated With Mortality Within 6 Months Among Critically Ill Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis
Actual Study Start Date : June 18, 2018
Actual Primary Completion Date : November 14, 2018
Actual Study Completion Date : January 15, 2019

Group/Cohort
ICU older patient
Older patient (> 65 years old) admitted to ICU with severe acute cholangitis



Primary Outcome Measures :
  1. mortality [ Time Frame: 180 days ]
    rate of survivors and non survivors


Secondary Outcome Measures :
  1. mortality [ Time Frame: 90 days ]
    rate of survivors and non survivors

  2. mortality [ Time Frame: 28 days ]
    rate of survivors and non survivors

  3. factors associated with 6 months mortality (underlying condition) [ Time Frame: Day 1 ]
    Functional status : presence or absence of denutrition defined by a BMI < 19 kg/m2 and/or albuminemia < 30 g/l and/or loss of weight > 5% during the last month (or > 10% during the last three months)

  4. factors associated with 6 months mortality (severity score) [ Time Frame: Day 1 ]
    Simplified Acute Physiology Score 2 Minimum value : 0 / Maximun value 163

  5. factors associated with 6 months mortality (Presence of hemodynamic failure) [ Time Frame: Up to 7 days ]
    infusion of catecholamine (ie norepinephrine) during the ICU stay, yes or not

  6. factors associated with 6 months mortality (Presence of respiratory failure) [ Time Frame: Up to 7 days ]
    number of day(s) under mechanical ventilation

  7. factors associated with 6 months mortality (Presence of renal failure) [ Time Frame: Up to 7 days ]
    number od day(s) under renal replacement therapy

  8. Clinical evolution [ Time Frame: Day 3 ]
    Change in Sequential Organ Failure score between Day 1 and Day 3. We measured the Sepsis-related Organ Failure Assessment (SOFA) score at day and day 3 and then made the difference between the two scores the SOFA score could range between 0 and 24 We calculated the score at day 1 and day 3 and made the difference An absence or a small difference between the 2 days is associated with a worse outcome



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients > 65 years old admitted to the ICU for acute severe cholangitis
Criteria

Inclusion Criteria:

  • > 65 years old
  • ICU admission for acute cholangitis
  • follow up in the same center after the ICU stay

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831529


Locations
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France
CHR Mercy
Metz, Lorraine, France, 57000
Emmanuel NOVY
Vandoeuvre Les Nancy, Lorraine, France, 54500
Sponsors and Collaborators
Central Hospital, Nancy, France
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03831529    
Other Study ID Numbers: PSS2017/ANGIOCHOLREA-NOVY/NK
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Central Hospital, Nancy, France:
critically ill
mortality
outcome
treatment intensity level
Additional relevant MeSH terms:
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Cholangitis
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases