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

Prognostic Factors Associated With Mortality Within 6 Months Among Critically Ill Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis

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).

Study Overview

• Status: Completed
• Conditions: Cholangitis Infective; Elderly Person

• Study Type: Observational
• Enrollment (Actual): 204

Contacts and Locations

Study Locations

• France
  • Lorraine
    • Metz, Lorraine, France, 57000
      • CHR Mercy
    • Vandoeuvre Les Nancy, Lorraine, France, 54500
      • Emmanuel NOVY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients > 65 years old admitted to the ICU for acute severe cholangitis

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	rate of survivors and non survivors	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	rate of survivors and non survivors	90 days
mortality	rate of survivors and non survivors	28 days
factors associated with 6 months mortality (underlying condition)	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)	Day 1
factors associated with 6 months mortality (severity score)	Simplified Acute Physiology Score 2 Minimum value : 0 / Maximun value 163	Day 1
factors associated with 6 months mortality (Presence of hemodynamic failure)	infusion of catecholamine (ie norepinephrine) during the ICU stay, yes or not	Up to 7 days
factors associated with 6 months mortality (Presence of respiratory failure)	number of day(s) under mechanical ventilation	Up to 7 days
factors associated with 6 months mortality (Presence of renal failure)	number od day(s) under renal replacement therapy	Up to 7 days
Clinical evolution	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	Day 3

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Publications and helpful links

General Publications

• Novy E, Carrara L, Remen T, Chevaux JB, Losser MR, Louis G, Guerci P. Prognostic factors associated with six month mortality of critically ill elderly patients admitted to the intensive care unit with severe acute cholangitis. HPB (Oxford). 2021 Mar;23(3):459-467. doi: 10.1016/j.hpb.2020.08.003. Epub 2020 Aug 22.

Study record dates

Study Major Dates

• Study Start (Actual): June 18, 2018
• Primary Completion (Actual): November 14, 2018
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: February 4, 2019
• First Posted (Actual): February 6, 2019

Study Record Updates

• Last Update Posted (Actual): February 6, 2019
• Last Update Submitted That Met QC Criteria: February 4, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: outcome; critically ill; mortality; treatment intensity level
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholangitis
• Other Study ID Numbers: PSS2017/ANGIOCHOLREA-NOVY/NK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No