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

• ClinicalTrials.gov Identifier: NCT03831529
• Recruitment Status: Completed
• First Posted: February 6, 2019
• Last Update Posted: February 6, 2019
• Sponsor: Central Hospital, Nancy, France
• Information provided by (Responsible Party): Central Hospital, Nancy, France

Study Description

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

Study Design

• 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

Groups and Cohorts

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

France

CHR Mercy

Metz, Lorraine, France, 57000

Emmanuel NOVY

Vandoeuvre Les Nancy, Lorraine, France, 54500

Sponsors and Collaborators

Central Hospital, Nancy, France

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Central Hospital, Nancy, France
• ClinicalTrials.gov Identifier: NCT03831529
• Other Study ID Numbers: PSS2017/ANGIOCHOLREA-NOVY/NK
• First Posted: February 6, 2019
• Last Update Posted: February 6, 2019
• Last Verified: February 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases